Baseline BMI Research Articles

The effect of a low-calorie diet on depressive symptoms in individuals with overweight or obesity: a systematic review and meta-analysis of interventional studies.

Individuals with overweight or obesity are at a high risk for so-called 'atypical' or immunometabolic depression, with associated neurovegetative symptoms including overeating, fatigue, weight gain, and a poor metabolic profile evidenced e.g. by dyslipidemia or hyperglycemia. Research has generated preliminary evidence for a low-calorie diet (LCD) in reducing depressive symptoms. The aim of the current systematic review and meta-analysis is to examine this evidence to determine whether a LCD reduces depressive symptoms in people with overweight or obesity. Eligible studies were identified through PubMed, ISI Web of Science, and PsycINFO until August 2023. Standardized mean differences (SMDs) were derived using random-effects meta-analyses for (1) pre-post LCD comparisons of depression outcomes, and (2) LCD v. no-diet-control group comparisons of depression outcomes. A total of 25 studies were included in the pre-post meta-analysis, finding that depression scores were significantly lower following a LCD (SMD = -0.47), which was not significantly moderated by the addition of exercise or behavioral therapy as a non-diet adjunct. Meta-regressions indicated that a higher baseline BMI and greater weight reduction were associated with a greater reduction in depression scores. The intervention-control meta-analysis (n = 4) found that overweight or obese participants adhering to a LCD showed a nominally lower depression score compared with those given no intervention (SMD = -0.29). There is evidence that LCDs may reduce depressive symptoms in people with overweight or obesity in the short term. Future well-controlled intervention studies, including a non-active control group, and longer-term follow-ups, are warranted in order to make more definitive conclusions.

Illustration of association between change in prostate-specific antigen (PSA) values and time to tumor status after treatment for prostate cancer patients: a joint modelling approach

BackgroundProstate cancer (PCa) is the most prevalent tumor in men, and Prostate-Specific Antigen (PSA) serves as the primary marker for diagnosis, recurrence, and disease-free status. PSA levels post-treatment guide physicians in gauging disease progression and tumor status (low or high). Clinical follow-up relies on monitoring PSA over time, forming the basis for dynamic prediction. Our study proposes a joint model of longitudinal PSA and time to tumor shrinkage, incorporating baseline variables. The research aims to assess tumor status post-treatment for dynamic prediction, utilizing joint assessment of PSA measurements and time to tumor status.MethodsWe propose a joint model for longitudinal PSA and time to tumor shrinkage, taking into account baseline BMI and post-treatment factors, including external beam radiation therapy (EBRT), androgen deprivation therapy (ADT), prostatectomy, and various combinations of these interventions. The model employs a mixed-effect sub-model for longitudinal PSA and an event time sub-model for tumor shrinkage.ResultsResults emphasize the significance of baseline factors in understanding the relationship between PSA trajectories and tumor status. Patients with low tumor status consistently exhibit low PSA values, decreasing exponentially within one month post-treatment. The correlation between PSA levels and tumor shrinkage is evident, with the considered factors proving to be significant in both sub-models.ConclusionsCompared to other treatment options, ADT is the most effective in achieving a low tumor status, as evidenced by a decrease in PSA levels after months of treatment. Patients with an increased BMI were more likely to attain a low tumor status. The research enhances dynamic prediction for PCa patients, utilizing joint analysis of PSA and time to tumor shrinkage post-treatment. The developed model facilitates more effective and personalized decision-making in PCa care.

Early- and later-stage persistence with antiobesity medications: A retrospective cohort study.

The study's objective was to examine the percentage of patients with an initial antiobesity medication (AOM) fill who were persistent with AOM at 3, 6, and 12 months and to characterize factors associated with persistence at 12 months. This retrospective cohort study used electronic health records from January 2015 to July 2023 in a large health system in Ohio and Florida and included adults with BMI ≥30 kg/m2 who had an initial AOM prescription filled between 2015 and 2022. The authors identified 1911 patients with a median baseline BMI of 38 (IQR, 34-44). Over time, 44% were persistent with AOM at 3 months, 33% at 6 months, and 19% at 12 months. Across categories of AOM, the highest 1-year persistence was in patients receiving semaglutide (40%). Semaglutide (adjusted odds ratio [AOR] = 4.26, 95% CI: 3.04-6.05) was associated with higher odds of 1-year persistence, and naltrexone-bupropion (AOR = 0.68, 95% CI: 0.46-1.00) was associated with lower odds, compared with phentermine-topiramate. Among patients who were persistent at 6 months, a 1% increase in weight loss at 6 months was associated with 6% increased odds of persistence at year 1 (AOR = 1.06, 95% CI: 1.03-1.09). Later-stage persistence with AOM varies considerably based on the drug and the weight loss at 6 months.

IBC-Oxford University2023_BJSOral_17The Endoscopic Sleeve Megaplication (ESM): Preliminary Results of a Modification of a Standard Procedure to Reduce the Cost with Maintaining the Effectiveness. A six-month follow-up.

Abstract Aims The cost of POSE 2.0 is very high, being one of the limitations of the accessibility of this procedure. The Endoscopic Sleeve Megaplication (ESM) procedure involves a novel pattern of full-thickness gastric body plications to shorten and narrow the stomach using the IOP platform (USGI Medical, San Clemente, CA) and durable suture anchor pairs g-Cath and two g-Lix simultaneously to achieve larger folds, reducing the number of sutures per procedure. Our prospective trial examined the safety and durability of ESM in adults with obesity grade I and II. Methods Adults suffering obesity underwent ESM in our centre. A single line of double plications in the greater curvature from incisura till 3-4 cm from gastro-oesophageal junction, single plications were placed in distal body anterior and posterior walls to close the diameter of the distal body under 10 mm. Primary outcomes were safety, durability of plications at 3-, 6-, 12- and 24-month follow-up and the cost effectiveness of the technique. Safety will be determined by the incidence of any serious adverse events reported either by the subject or observed by the investigator, relating to the procedure either peri-procedurally or in the follow-up period. All adverse events will be documented. Secondary outcomes were total body weight loss (%TBWL), proportion of patients achieving > 5% TBWL at 12 months and reduction of the cost of the procedure compared to standard POSE 2.0 technique, based on the average number of plications placed. Results 13 patients (7F, age 45 ± 9.9 years) underwent ESM between February 2022 to September 2022. Baseline BMI was 37.2 ± 3.1 kg/m2. Technical success was 100%. An average of 10 ± 2 suture anchor pairs were placed in each case. At six months, patients (n=13) achieved a 16.1 ± 3.9 % total weight loss (%TWL), with 84,61 % achieving more than 10 % TWL. Blood test results, state that insulin resistance and liver enzymes improved. No serious adverse events were reported. The reduction of an average of 8 plications compared to the standard POSE 2.0 pattern brings a significant reduction of the cost of the procedure. Conclusions ESM procedure happens to be effective for treating obesity and its related comorbidities. It is a safe, durable and a cost-effective procedure however, it is necessary to complete a long-term follow-up and carry out studies with larger samples to proclaim those benefits.

The effect of computerized cognitive training and exercise on white matter integrity: a secondary analysis of a randomized controlled trial

AbstractBackgroundAs a consequence of aging, the structure of the brain can be negatively impacted, and consequently, cognitive function. Although aerobic exercise and computerized cognitive training (CCT) are promising lifestyle interventions to prevent or delay cognitive decline, the underlying mechanisms of the effect of CCT, with or without exercise, on cognitive function remain poorly understood. Diffusion tensor imaging (DTI) is a neuroimaging technique for detecting changes in white matter (WM) tissue. Common DTI metrics such as fractional anisotropy (FA) can be summarized as a measure of overall WM integrity. The aim of this analysis was to explore the effect of CCT, with or without exercise, on WM integrity in healthy older adults.MethodsThis sub‐analysis included 65 community‐dwelling older adults aged 65‐85 years. Participants were enrolled in an 8‐week proof‐of‐concept randomized controlled trial and were assigned to either: 1) Group‐based CTT (Fit Brains; FBT; n = 19) 3x/week for 1hr plus 3x/week home‐based training; 2) Group‐based CCT preceded by exercise (ExFBT; n = 22) 3x/week for 1hr plus 3x/week home‐based training or; 3) Group‐based balanced‐and‐toned (BAT; n = 24) classes 3x/week for 1hr (control). DTI scans were acquired at baseline and at trial completion. Analysis of covariance (ANCOVA) evaluated treatment effects on FA at trial completion controlling for baseline age, MoCA, BMI, and FA. We conducted planned contrasts of FBT vs. BAT and ExFBT vs. BAT. In addition, we included an exploratory comparison between ExFBT vs. FBT.ResultsWe found significant group differences in fornix and superior longitudinal fasciculus (SLF) FA at trial completion. Planned contrasts revealed significantly greater fornix FA in BAT vs. FBT (mean difference = 0.015, 95%CI = 0.002‐0.029). Also, fornix FA was significantly greater in ExFBT vs. FBT (mean difference = 0.017, 95%CI = 0.003‐0.031). In addition, SLF FA was significantly greater in ExFBT vs. FBT (mean difference = 0.008, 95%CI = 0.001‐0.014) at trial completion.ConclusionThese findings suggest CCT alone may be detrimental to WM integrity, potentially due to its sedentary nature.

Health‐related quality of life in full spectrum of Alzheimer’s disease: a longitudinal analysis

AbstractBackgroundUnderstanding the health‐related quality of life (HR‐QoL) in subjective cognitive decline (SCD), mild cognitive impairment (MCI) and demented patients is essential from the health economic perspective for evaluating new disease‐modifying treatments and preventive interventions. This study aims to assess HR‐QoL and the factors associated with longitudinal change in HR‐QoL in the full spectrum of Alzheimer’s disease.MethodLongitudinal data from 918 SCD and 1,346 MCI patients from the MEMENTO cohort were included in the study. MCI was defined as performing one standard deviation (SD) worse than the age, sex and education‐level thresholds in one or more cognitive domains identified within six months of the study enrollment. SCD was defined as having isolated subjective cognitive complaints but without any objective cognitive deficit and aged 60 years or older. HR‐QoL was measured by EuroQol EQ‐5D‐3L patient‐reported version. Linear mixed‐effect models with disease stage as a time‐varying covariate were used to (1) assess the utility changes over time across the dementia spectrum and (2) compare the utility changes between amyloid positive and negative SCD and MCI patients.ResultAt baseline, mean utilities were 0.84 ± 0.16 and 0.81 ± 0.18 in SCD and MCI patients. Linear mixed effect models estimated that the utilities were ‐0.016 (SE 0.003), ‐0.07 (SE 0.009), ‐0.18 (SE 0.014) and ‐0.36 (SE 0.034) lower than SCD in patients with MCI, mild, moderate and severe dementia over the study period. Time is associated with a significant decrease in utility with ‐0.008 (SE 0.001) per year. Baseline age, BMI, female, diabetes, cardiovascular history, neuropsychiatric symptoms and inability to perform Instrumental activity of daily living (IADL) were negatively associated with utilities. Amyloid‐positive SCD patients showed a faster decline in utility than amyloid‐negative SCD patients (p < 0.05). The decrease was not statistically significant in amyloid‐positive MCI patients compared to amyloid‐negative MCI.ConclusionHealth utilities decrease over time in all stages of dementia, and the decline is steeper in moderate and severe stages. Positive amyloid accelerates health utility decline in SCD but not MCI individuals. The ability to perform IADL is the major factor affecting HR‐QoL in all phases of dementia.

A co-designed, community-based intensive health behavior intervention promotes participation and engagement in youth with risk factors for type 2 diabetes.

Obesity among youth (children and adolescents) is associated with increased risk for youth-onset type 2 diabetes. Lifestyle change can delay or prevent the development of type 2 diabetes, yet real-world implementation of health behavior recommendations is challenging. We previously engaged youth with risk factors for type 2 diabetes, their caregivers, and professionals in a human-centered design study to co-design a lifestyle change program. Here we report the outcomes for this 16-week co-designed lifestyle change program for youth at risk for T2D and their caregivers. This single-arm family-based cohort study included youth aged 7-18 years, with BMI ≥85th percentile (overweight or obese) and at least one additional risk factor for type 2 diabetes, and their caregivers. Clinical (BMI, HbA1c), self-reported physical activity, and quality of life outcomes were evaluated at baseline (B), post-intervention (M4), and 1 year (M12) following the intervention. Seventy-eight youth (mean age 12.4 ± 2.7y, 67% female, 37.8% white) and 65 caregivers were included in the data analysis. Youth baseline BMI z-scores (2.26 ± 0.47) and HbA1c (5.3 ± 0.3) were unchanged at follow up time points [BMI z-scores M4 (2.25 ± 0.52), M12 (2.16 ± 0.58), p-value 0.46], [HbA1c M4 (5.3 ± 0.3), M12 (5.2 ± 0.3), p-value (0.04)]. Youth reported increased physical activity at M4 (p = 0.004), but not at M12. Youth quality of life scores increased at M12 (p=0.01). Families who attended at least one session (n=41) attended an average of 9 out of 16 sessions, and 37 percent of families attended 13 or more sessions. A co-designed, community-based lifestyle intervention promotes increased physical activity, improved quality of life, maintenance of BMI z-scores and HbA1c, and engagement in youth with risk factors for T2D.

Influence and Role of the Body Mass Index and Its Development on the Course of Pediatric HSCT - a Retrospective Analysis

T Stetter and M Döring contributed equally to this work. Background Children and adolescents are at increased risk of malnutrition during the course of hematopoietic stem cell transplantation (HSCT). Increased endocrine activity, a catabolic metabolic state and inflammatory processes increase the energy metabolism and therapy-associated side effects impair nutritional intake. Studies have shown that the nutritional status before HSCT in adults has a decisive influence on the time afterwards. The role of nutritional status in children and adolescents before, during, and after HSCT remains poorly understood. Patients and Methods In this monocentric, retrospective study, data from patients who underwent autologous or allogeneic HSCT at the University Children's Hospital Tübingen between November 2012 and November 2021, were analyzed. Exclusion criteria were known gastrointestinal malformations, permanent enteral/parenteral nutrition, and known chronic inflammatory bowel disease before HSCT. On three observation days (baseline: day of in-patient admission, day +30, and day +200 after HSCT) data on age-adjusted BMI percentiles, incidence of transplant-associated adverse events (TRAE; e.g., graft-versus-host disease (GvHD), veno-occlusive disease (VOD), mucositis, infection), and survival (up to 10 years after HSCT; last note in file). were collected. Patients were categorized into alloHSCT and autoHSCT Patients as well as BMI-percentile groups depending on baseline BMI percentile: <3rd percentile, 3rd-<10th percentile, 10th-<25th percentile, 25th-<50th percentile, 50th-<75th percentile, 75th-97th percentile, and >97th percentile. Results A total of 365 patients with a median age of 9 years (0-23 years), 56% of whom were female, were studied. Of these, 307 (84%) underwent allogeneic and 58 (16%) autologous HSCT. The underlying disease was malignant in 262 cases (72%) and non-malignant in 103 cases (28%). The proportions of patients fell into the corresponding BMI percentile groups at the respective observation days (see Table). During the course of time until day +200 after HSCT, the BMI percentile category remained the same in 28% of the cases, in 17%, 10%, and 3% of cases, respectively, patients moved up one, two, and >2 categories, respectively; in 20%, 12%, and 9% of cases, patients dropped one, two, and >2 categories, respectively, compared to baseline. However, comparing the alloHSCT and autoHSCT patients, a different distribution in the development until day +200 is noticeable. Overall, 27% of the alloHSCT and 44% of autoHSCT patients ascend one or more percentile groups, whereas 46% of the alloHSCT and 22% of the autoHSCT patients descend one or more BMI percentile categories. Higher-grade intestinal GvHD stage 3-4 occurred statistically more frequently in the percentile group >75th-97th ( p=0.0028), but when all grades were considered together, no significant clustering in any group was observed. A significant accumulation ( p=0.0413) of VOD, BKV cystitis ( p=0.0021), and Viremia ( p=0.0081) was found in the group >75th-97th percentile. A total of 115 patients (32%) died during the observation period. In the alloHSCT group, 35 deaths (12% of alloHSCT patients) fell under TRM. Here, of the 35 deceased, 12 (34% of deceased, 4% of total alloHSCT patients) were ascribed to the >75th-97th percentile group; the median proportion of deceased patients was 9% (1% of alloHSCT group) in the other percentile groups. In the autoHSCT group, a total of 23 patients (41%) died; of these, all were due to progression or recurrence of the underlying disease. The <3rd percentile and >25th-50th percentile groups each recorded the most deaths, with 26% of those who died and 11% of patients in the autoHSCT group, respectively. Conclusions Contrary to the expectation that particularly underweight pediatric HSCT patients might be more affected by complications, this data collection showed statistically clustered complications and TRM in the group of patients between the 75th-97th BMI percentiles. Although this is only a status description of body weight and length during follow-up, and not a specific survey of nutritional status, the data analysis suggests that HSCT patients in the overweight range should be focused on more closely. A prospective survey of differential nutritional status in pediatric HSCT patients is currently being conducted at our study center.

2200. The Antibiotic Steward's Nightmare: Long-Term Antibiotics in An Infectious Disease Practice

Abstract Background The effects of long-term antibiotic use, including the frequency of recurrent infections and new-onset resistant infections, are not fully understood. The role of antibiotics in the disruption of the gut microbiota has been well-described, impacting insulin susceptibility and lipid deposition. Prolonged antibiotic use may have potential to be implicated in obesity, diabetes, and hyperlipidemia. There may also be an effect on the incidence of secondary infections with new organisms, the frequency of breakthrough infections from the index organism, and the selection for resistant infections. Methods This retrospective study evaluated 78 patients seen at an outpatient infectious disease practice. Inclusion criteria were patients with prescription of an oral antibiotic for 90 or more consecutive days between 9/1/18 and 12/31/2019, who utilize a health system pharmacy. Data was collected from patient charts at baseline prior to antibiotic initiation, and at time of most recent follow up after the initiation of antibiotic. Results Cephalexin (37.2%), azithromycin (34.6%) and amoxicillin (12.8%) were the most common antibiotics prescribed. Mean patient age was 69.4 years. Indications for antibiotic use included NTM infections (34.6% of cases), prosthetic joint infections (21.8%), recurrent UTIs (10.3%), and prosthetic valve infection (7.7%). 23.4% of patients experienced breakthrough infection with the index organism, while 21.8% experienced new, unrelated infection during follow-up, of which 52.9% had a resistant organism isolated. Mean BMI at baseline was 26.9, and BMI at follow-up was 27.3. The difference between baseline and follow-up BMI was not statistically significant (p=0.177). A1C, LDL, and cholesterol rose from baseline to follow-up, but did not reach statistical significance. Conclusion Patients on long-term antibiotics had a numerical increase in BMI, A1C, LDL, and cholesterol values following initiation, but those increases were not statistically significant. Recurrence of infection and emergence of resistance was common. The small sample size and limitation of studying patients from one practice within one health system pharmacy are limitations of the study. Further studies with larger sample sizes and comparative groups by diagnosis are needed. Disclosures All Authors: No reported disclosures

The Impact of Fluid Therapy on Glycemic Variation in Non-diabetic Patients Undergoing Laparoscopy.

Background Hyperglycemia is a risk factor for perioperative morbidity and mortality. A surgical procedure triggers a physiological stress response, which culminates in insulin resistance by activating the sympathetic autonomic system. The impact of fluid management in the perioperative period on the glycemic variation of patients has not been thoroughly investigated. Methods This study, which included 42 non-diabetic patients undergoing laparoscopic surgeries, was an observational, prospective cohort study. The sample was split into two groups according to the type of fluid used intraoperatively: polyelectrolyte and 5% glucose polyelectrolyte. Results No significant differences were found between the groups in demographic and baseline data, including age, BMI, and American Society of Anesthesiologists (ASA) physical status. There were no differences in glycemic variation between the two groups. Blood glucose varied over time with statistical significance in the perioperative period but with no difference between the two groups. Conclusion Using 5% glucose polyelectrolyte in laparoscopic surgery for non-diabetic patients with ASA physical status 3 or lower did not significantly affect glycemic variation compared to polyelectrolyte. These results suggest the possibility of optimizing resources and minimizing waste without compromising patient homeostasis in perioperative care.

Global benchmarks in primary robotic bariatric surgery redefine quality standards for Roux-en-Y gastric bypass and sleeve gastrectomy.

Whether the benefits of the robotic platform in bariatric surgery translate into superior surgical outcomes remains unclear. The aim of this retrospective study was to establish the 'best possible' outcomes for robotic bariatric surgery and compare them with the established laparoscopic benchmarks. Benchmark cut-offs were established for consecutive primary robotic bariatric surgery patients of 17 centres across four continents (13 expert centres and 4 learning phase centres) using the 75th percentile of the median outcome values until 90 days after surgery. The benchmark patients had no previous laparotomy, diabetes, sleep apnoea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, history of thromboembolic events, BMI greater than 50 kg/m2, or age greater than 65 years. A total of 9097 patients were included, who were mainly female (75.5%) and who had a mean(s.d.) age of 44.7(11.5) years and a mean(s.d.) baseline BMI of 44.6(7.7) kg/m2. In expert centres, 13.74% of the 3020 patients who underwent primary robotic Roux-en-Y gastric bypass and 5.9% of the 4078 patients who underwent primary robotic sleeve gastrectomy presented with greater than or equal to one complication within 90 postoperative days. No patient died and 1.1% of patients had adverse events related to the robotic platform. When compared with laparoscopic benchmarks, robotic Roux-en-Y gastric bypass had lower benchmark cut-offs for hospital stay, postoperative bleeding, and marginal ulceration, but the duration of the operation was 42 min longer. For most surgical outcomes, robotic sleeve gastrectomy outperformed laparoscopic sleeve gastrectomy with a comparable duration of the operation. In robotic learning phase centres, outcomes were within the established benchmarks only for low-risk robotic Roux-en-Y gastric bypass. The newly established benchmarks suggest that robotic bariatric surgery may enhance surgical safety compared with laparoscopic bariatric surgery; however, the duration of the operation for robotic Roux-en-Y gastric bypass is longer.

Atrial fibrillation and electronic healthcare records in UK Biobank: Relevance of ascertainment in primary and secondary care for risk factor associations and patient outcomes

Abstract Background Electronic health data have played a pivotal role in the development and success of large-scale biobanks, and have enabled a range of epidemiological studies with wide-ranging applications[1]. Hospital admissions (HA) data are often used to identify individuals with disease, but this may result in incomplete ascertainment for conditions such as atrial fibrillation (AF), which often does not require hospitalisation. Understanding ascertainment through primary care (PC) data is essential to determine the potential benefits and drawbacks of using difference data sources for AF ascertainment. Purpose To explore potential differences between AF cases identified from PC and HA data with respect to participant characteristics, timing of ascertainment, and AF-related sequelae. Methods UK Biobank is a large prospective study with PC and HA data available in 230,000 participants[2]. Incident AF cases were defined using a combination of Read clinical codes in PC data and ICD-10 diagnostic and OPCS-4 procedural codes in HA data. Individuals were divided into 3 groups representing whether AF was defined using PC records only (PC-only), hospital admissions only (HA-only), or both (PC+HA). Descriptive statistics and multinomial regression were used to describe differences between groups in terms of ascertainment timing, risk factor associations, and post-AF stroke and death. Results During a median follow-up of 7 years, 7,142 incident AF cases were identified: 22% through PC-only (1571 new cases), 30% through HA-only, and 48% via PC+HA. In the latter group, when AF was first identified through PC (3827), there was an average lag of 1.3 years before it was identified in HA data, but a 5-year lag in the opposite direction (Figure 1). The patterns of associations for baseline age, sex, BMI, smoking, blood pressure, and composite clinical risk (CHARGE-AF[3]) suggested little evidence of systematic differences between the groups (Figure 2). However, the associations of AF with baseline diabetes, heart failure, myocardial infarction, and an AF polygenic risk score[4] suggested HA-only cases had a higher prevalence of cardiometabolic comorbities, but lower overall genetic AF risk. Moreover, HA-only AF cases had similar rates of subsequent stroke but substantially higher rates of death (73.2 per 1000 person-years) compared to the PC-only and PC+HA groups (6.6 and 23.1, respectively). Conclusion PC data identifies 28% additional AF cases than HA alone in UK Biobank, with important implications for the power of epidemiological studies. The strength of associations between risk factors and AF varies by ascertainment source, as do the rates of AF-related sequelae, suggesting that further studies comparing treatment in different groups may be warranted. Furthermore, for AF identified in HA alone, improved consistency and timeliness of routine recording of AF in PC may have important implications for management and risk of sequelae.

High-normal systolic blood pressure in early midlife is a stronger risk factor for incident hypertension later in life for women than men

Abstract Background We have previously found that having high-normal blood pressure (BP) in early midlife is a stronger risk factor for incident hypertension later in life for women than for men. Whether this risk is related both to high-normal systolic and diastolic BP is not known. Purpose To explore whether there is a sex difference in risk of incident hypertension related to high-normal systolic and diastolic BP in early midlife. Methods In the community-based Hordaland Health Study, 1025 women and 703 men were examined at age 42 years (baseline) and re-examined after 26 years. Patients with hypertension at baseline were excluded. Attended BP was measured in triplets, and clinic BP taken as the average of the two last measurements. High-normal systolic BP was identified as systolic BP of 130-139 mmHg and high normal diastolic BP as diastolic BP 85-89 mmHg. Incident hypertension was identified as BP ≥140/90 mmHg or patient reported use of antihypertensive drugs on the follow-up visit. The associations of systolic and diastolic BP at baseline with incident hypertension at follow-up were explored in sex specific multivariable logistic regression analyses. Multivariable analysis looking at high-normal diastolic BP was adjusted for baseline BMI, systolic BP, high-normal diastolic BP , heart rate, physical activity, daily smoker, cholesterol, triglycerides. Multivariable analysis looking at high-normal systolic BP was adjusted for baseline BMI, diastolic BP, high normal systolic BP , heart rate, physical activity, daily smoker, cholesterol, triglyceride. Results are presented as odds ratios (OR), 95% confidence intervals (CI) and p-values. Results At baseline, average BP was 119/73 mmHg in women and 126/76 mmHg in men (p<0.001). A high-normal systolic BP was found in 16% of women and 35% of men (p< 0.001). A high-normal diastolic BP was found in 7% of women and 11% of men(p=0.008). After 26 years of follow-up, 39% of women and 45% of men had developed hypertension (p<0.05). In multivariable logistic regression analyses, high-normal systolic and diastolic BP at baseline predicted incident hypertension at follow up in both sexes (Table 1). High-normal systolic BP was a significantly stronger predictor for incident hypertension in women (OR 2.32, CI 1.5-3.5) with p<0.01 for sex interaction (Table 1). In men, high-normal diastolic BP at baseline, was the strongest predictor of incident hypertension (OR 2.1, 95% CI 1.2-3.7), but no sex-interaction was found for high-normal diastolic BP, possibly due to low numbers. Conclusions Having a high-normal systolic BP in early midlife is a greater risk for developing hypertension later in life for women than men.Table 1

Abstract 15307: Sex-Specific Cognitive Effects of Intensive Systolic Blood Pressure Lowering in Patients With and Without Diabetes Mellitus

Background: The SPRINT trial demonstrated that intensive systolic blood pressure (SBP) lowering (<120 mm Hg) reduced risk of mild cognitive impairment compared to standard SBP control (<140 mm Hg). However, the ACCORD-BP trial did not show the same effect in patients with diabetes. Aims: This study aimed to 1) determine the impact of intensive SBP on cognitive impairment in patients with and without diabetes by analyzing individual patient data of ACCORD-BP and SPRINT, using three cognitive domains and the same follow-up durations, and 2) assess potential sex differences in the effect of intensive SBP lowering on cognitive function in patients with and without diabetes. Methods/Approach: We pooled individual patient data from the SPRINT and ACCORD-BP and standardized cognitive outcomes at baseline, 20-24 months, and 40-48 months post-randomization. Both studies randomized hypertensive patients to intensive SBP control or standard SBP control. Cognitive outcomes included general cognitive function, cognitive processing speed, and memory. Linear mixed models were employed, adjusting for covariates such as age, baseline BMI, SBP, eGFR and LDL. Analyses were repeated separately for patients with and without diabetes and for men and women. Results: The study cohort comprised of 10,800 patients (mean age 67.2 ±9.1 years; mean baseline SBP:139.6 ± 15.6 mmHg, with 14.7% having diabetes and 61.8% being women. Patients without diabetes in the intensive SBP control group had an accelerated decline in processing speed decline compared to the standard control group (P time*treatment interaction=0.02). Patients with diabetes exhibited similar rates of decline in all cognitive outcomes across treatment groups. Stratifying by sex, intensive SBP control was associated with improved memory in female patients (estimated sd=0.07 (0.03), p=0.06), and faster decline in processing speed in male patients. (p=0.03). Conclusions: The effects of intensive SBP control on general cognitive function were comparable between patients with and without diabetes and between men and women. While intensive SBP control was associated with accelerated decline in cognitive processing speed in patients without diabetes, it was linked to improved memory in female patients.

Abstract 12762: Plasma Lipidomic Signature of Peripheral Artery Disease in Young and Middle-Aged American Indian Individuals: The Strong Heart Family Study

Introduction: Dyslipidemia is an independent risk factor for peripheral artery disease (PAD). Ankle-brachial index (ABI) is a sensitive and cost-effective tool for screening and predicting PAD. The association between individual lipid species and the progression in subclinical PAD, assessed by change in ABI, remains to be determined, especially in understudied populations at high risk. Hypothesis: To identify individual molecular lipid species associated with PAD progression in American Indians, independent of traditional risk factors. Methods: Using an untargeted lipidomic method by liquid chromatography-mass spectrometry, we repeatedly measured 1,542 individual lipid species in 2,830 fasting plasma samples at two time points (2001-2003 and 2006-2009, mean 5 years apart) from 1,415 unique American Indians in the Strong Heart Family Study. Participants were free of prevalent PAD at both time points. ABI was measured in the right arm and bilateral (both left and right posterior tibial artery) using a handheld Doppler and was analyzed as a continuous variable. We first identified baseline lipid species associated with change in ABI by generalized estimating equation models, adjusting for baseline age, sex, BMI, smoking, eGFR, diabetes, hypertension, lipid-lowering medication and baseline ABI. We then examined the longitudinal association between change in lipid species and change in ABI, adjusting for same covariates plus baseline lipids. Results: Participants (63% female) were aged between 18-65 (mean 38) at baseline and 22-72 (mean 43) at follow-up. Higher baseline levels of 36 lipid species were positively (ORs: 1.01 - 3.60), whereas 16 lipid species were inversely (ORs: 0.26 - 0.98), associated with change in ABI. Longitudinal changes in 77 lipid species, largely glycerolipids, glycerophospholipids, and sphingolipids, were significantly associated with change in ABI during 5-year follow-up. Conclusions: Baseline plasma lipid species and their longitudinal changes over time are significantly associated with PAD progression beyond known risk factors. These findings shed light on the role of dyslipidemia in PAD among young and middle-aged American Indians who suffer high rates of obesity, diabetes and other cardiometabolic disorders.

Abstract 16764: Changes in Triglyceride Levels During Omega-3 Fatty Acid Supplementation, and Incident Cardiovascular Events: Secondary Analysis From the OMEMI Trial

Background: Elevated triglyceride levels are associated with increased cardiovascular risk. Omega-3 polyunsaturated fatty acids (n-3PUFA) are known to reduce triglyceride levels, but whether changes in triglycerides mediate any cardiovascular effects of n-3PUFA, remains unclear. Methods: In the randomized controlled OMEMI trial, 1014 elderly (70-82 years) patients with a recent acute myocardial infarction (AMI) were treated with 1.8 g/day of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or placebo (corn oil) for two years, and followed for the primary outcome of MACE (AMI, coronary revascularization, stroke, heart failure hospitalization or all-cause death). Relative changes in triglycerides from baseline to 3 months (n=920, 91%), were associated with incident MACE (N=175) using landmark Cox regression models. Results: The median (Q1-Q3) baseline triglyceride concentration was 97 (74-135) mg/dL, and higher levels were associated with higher BMI, diabetes and heart failure, in multivariable models. After 3 months of treatment, triglycerides decreased by median -10% and 0% in the n-3PUFA and placebo groups, respectively, followed by relatively stable levels at 12 and 24 months ( Figure ). Greater triglyceride reductions at 3-months were associated with a lower risk of MACE in the n-3PUFA group (HR 1.98 [95%CI 1.23-3.17] per doubling, p=0.004; Figure ), and this persisted after adjusting for baseline triglycerides, age, sex, BMI and comorbidities (HR 2.34 [1.37-3.98], p=0.002). Changes in triglycerides did not associate with MACE in the placebo group (HR 1.13 [0.63-2.02], p=0.68). Conclusion: Treatment with 1.8 g/day of EPA/DHA modestly reduced triglyceride levels and greater on-treatment triglyceride-reductions were associated with a lower risk of MACE. Although the overall OMEMI-trial was neutral, these findings suggest that n-3PUFA-related triglyceride changes may play a role with respect to cardiovascular outcomes.

Abstract 15033: Development of an Interpretable Machine Learning Model for Predicting Individual Response to Antihypertensive Treatments

Introduction: Accurate prediction of individual response to anti-hypertensive treatment is crucial in enhancing the safety and efficiency of offering appropriate regimens to attain desired blood pressure (BP) goals. Hypothesis: Machine learning (ML) based models could accurately predict the BP reduction of different antihypertensive regimens. Methods: We utilized data from the LIGHT study, a pragmatic, cluster-randomized trial conducted in 94 primary care institutions in China, involving 13146 visits of 5192 patients who were required to attend the clinic for hypertension management every 3 months during an overall study period of 1 year. Clinical and laboratory variables, baseline BP, and anti-hypertensive therapies at baseline and at follow-up were used to develop models for predicting post-treatment individual BP response. Five ML algorithms were applied as candidate models, and mean squared error (MSE) was used to evaluate the model performance ( panel A ). Results: The mean (standard deviation) age of the study population at baseline was 64.2 (14.0) years, and 2207 (42.5%) were female. 29 features selected by the least absolute shrinkage and selection operator method and purposeful selection were used to build the model, including age, sex, weight, waist circumference, BMI, baseline systolic and diastolic BP, smoking status, visit interval, history of coronary heart disease, diabetes, and dyslipidemia, and baseline and prescript antihypertensive drugs. Among all candidate models, the Catboost model had the best performance with a training MSE of 149.6 and a validation MSE of 135.2 ( panel B ). The most important features include baseline BP, age, weight, and BMI ( panel C and D ). Conclusions: We developed an ML-based model for predicting the response to antihypertensive regimens for assisting clinicians to achieve individualized antihypertensive treatment effectively and safely.

Abstract 18229: The Effectiveness of a Student-Delivered Weight Loss Program in a High-Risk Urban Practice

Introduction: Obesity is a global epidemic contributing to CVD, the leading cause of death worldwide. Diet, exercise, and lifestyle are crucial to CVD prevention and treatment. The Healthy Eating Index (HEI) is a 13-component dietary analysis tool based on the Dietary Guidelines for Americans, with higher scores associated with lower CVD risk. Calculating the HEI involves a 24-hour food recall and complex scoring. The Diet Risk Score (DRS), a 9-question, efficient alternative screening tool, has been validated against the HEI. JeffWLP, a unique low-cost, long-term student-delivered nutrition education program, evaluates improvement in DRS. Hypothesis: JeffWLP participants in JeffWLP would demonstrate significant weight loss, increased physical activity, and improved DRS in urban at-risk patients. Methods: In this randomized controlled trial, 30 obese adults from an underserved urban population were randomized to intervention (n=18) or control/usual care (n=12) groups. Mean age was 46 +/- 13 years. 80% were African American, and 90% were female; mean baseline BMI was 38 +/- 5. Mean socioeconomic status, self-assessed using the MacArthur Scale, was 6 (maximum 10). JeffWLP includes 12 core weekly group and individual nutrition education counseling sessions, meal replacements, and an exercise component, followed by unlimited bimonthly maintenance counseling. Vitals were obtained pre, mid, and post-core intervention. Results: JeffWLP participants achieved mean weight loss of 6.1 +/- 7.8 lbs (p=0.01), or 2.7 +/- 3.3% body weight (p < 0.01) in 12 weeks. Mean DRS improved by 7 +/- 6 points (p <0.001). Number of weekend steps walked increased by 3500 +/- 3150 (p = 0.016). Pilot JeffWLP patients (n=7), sustained weight loss of 4.8 +/- 8.1 lbs, 285 days after enrollment (p = 0.17). Conclusions: Our study demonstrates the cost-effectiveness of JeffWLP for improving weight loss, exercise, and dietary risk in 12 weeks. We anticipate additional sustained improvements in this ongoing study with double the sample size; this additional data will be available at the AHA meeting. JeffWLP empowers medical students to improve health outcomes in disadvantaged, at-risk underserved populations affordably, addressing critical health disparities.

Body Mass Index and Clinical and Health Status Outcomes in Chronic Coronary Disease and Advanced Kidney Disease in the ISCHEMIA-CKD Trial

ObjectiveThis study aimed to assess whether an obesity paradox (lower event rates with higher body mass index [BMI]) exists in participants with advanced chronic kidney disease (CKD) and chronic coronary disease in the International Study of Comparative Health Effectiveness of Medical and Invasive Approaches (ISCHEMIA)-CKD, and whether BMI modified the effect of initial treatment strategy. MethodsBaseline BMI was analyzed as both a continuous and categorical variable (< 25, ≥ 25 to < 30, ≥ 30 kg/m2). Associations between BMI and the primary outcome of all-cause death or myocardial infarction (D/MI), and all-cause death, cardiovascular death, and MI individually were estimated. Associations with health status were also evaluated using the Seattle Angina Questionnaire-7, the Rose Dyspnea Scale, and the EuroQol-5D Visual Analog Scale. ResultsBody mass index ≥ 30 kg/m2 vs < 25 kg/m2 demonstrated increased risk for MI (hazard ratio [HR] [95% confidence interval] = 1.81 [1.12-2.92]) and for D/MI (HR 1.45 [1.06-1.96]) with a HR for MI of 1.22 (1.05-1.40) per 5 kg/m2 increase in BMI in unadjusted analysis. In multivariate analyses, a BMI ≥ 30 kg/m2 was marginally associated with D/MI (HR 1.43 [1.00-2.04]) and greater dyspnea throughout follow-up (P < .05 at all time points). Heterogeneity of treatment effect between baseline BMI was not evident for any outcome. ConclusionsIn the ISCHEMIA-CKD trial, an obesity paradox was not detected. Higher BMI was associated with worse dyspnea, and a trend toward increased D/MI and MI risk. Larger studies to validate these findings are warranted.

The Importance of Screening for Food Insecurity in Children with Sickle Cell Anemia: An Ancillary Study to the Severe Acute Malnutrition Feasibility Trial in Nigeria

Introduction Household food insecurity-lacking access to, or having uncertain access to, food that meets a person's dietary needs-is a longstanding problem in Nigeria that has continued to worsen in recent years. One of its most severe consequences is malnutrition, particularly affecting children due to their high nutrient demand coupled with higher energy expenditure. Even in high-income countries, such as the United States, many children with sickle cell anemia have lower weights and heights than their healthy peers. Due to their elevated nutrient requirements, children with sickle cell anemia may be at an even greater risk of malnutrition when faced with limited access to adequate food. The relationship between childhood food insecurity and malnutrition has been previously studied in younger children in Nigeria, but rarely in older children, and to our knowledge, never in older children with sickle cell anemia. We tested the hypothesis that there is a direct association between increased food insecurity and more severe malnutrition (lower body mass index [BMI] z-score) in older children with sickle cell anemia in Nigeria. Methods This was a planned analysis of the data of children enrolled in a feasibility trial for managing severe acute malnutrition in older children with sickle cell anemia in Nigeria (SAMS trial; #NCT03634488). In this study, children 5-12 years old with sickle cell anemia and uncomplicated severe acute malnutrition (BMI z-score &amp;lt;-3.0) were randomly assigned to receive either supplemental ready-to-use therapeutic food (RUTF) only or RUTF combined with moderate fixed-dose hydroxyurea therapy for 12 weeks. Baseline anthropometric data were obtained for each participant. Upon enrollment in the trial, the participants' caregivers completed the US Household Food Security Survey Module (HFSSM). Using the eight questions in the childhood portion of this standardized survey, we categorized the participants into three food security statuses: food security (0-1), low food security (2-4), and very low food security (5-8). Childhood food security scores were also measured as a continuous variable on a scale of 0-8, with higher scores indicating greater food insecurity. We constructed a linear regression model to estimate the association between childhood food insecurity and baseline BMI z-score. Results Data were collected between August 2021 and May 2022. The median age of the 108 participants in the study was 10.3 years (IQR 8.8-11.5). Most participants had low (55%) or very low (34%) food security. BMI z-score was not associated with categorical food security status (p=0.108). However, higher food insecurity as a continuous variable was associated with a lower BMI z-score (Pearson correlation -0.23, p=0.015; Figure 1). In a multivariable linear regression with sex, age at study entry, total hemoglobin, employment status, and head of household educational status, the childhood food insecurity score was negatively associated with the BMI z-score (Beta coefficient = -.05, p=0.047). Conclusions Our study reveals a high prevalence of food insecurity among older children with sickle cell anemia in Nigeria. Moreover, children experiencing higher food insecurity also exhibited more severe malnutrition, as evidenced by their lower BMI z-scores. Based on these results, we have started implementing food insecurity assessment as routine medical care in children with sickle cell anemia at multiple clinics in northern Nigeria. Children experiencing higher levels of food insecurity are referred to nutritional counseling, where they receive guidance on locally available nutrient-dense foods and preparation strategies. Figure 1.The predicted baseline body mass index z-score with 95% confidence intervals based on childhood food insecurity scores from a linear regression model of the participants in the SAMS trial.