Intensive Lifestyle Modification Research Articles

Reversal of Diabetic Nephropathy with Intensive Lifestyle Intervention: A Case Report

Background: Diabetic nephropathy is a leading cause of chronic kidney disease, and early intervention is very important to prevent the progression of the disease .Case Presentation: A 45-year-old male patient who is a known case of type 2 diabetes mellitus from 10 years and nephropathy from 1 year underwent intensive lifestyle modification, including caloric restriction, high-intensity interval training, and stress management, alongside medication. Results: After 6 months of following the advice , significant improvements were observed:HbA1c decreased from 10.5% to 6.5%, eGFR increased from 45 to 60 ml/min/1.73m, proteinuria reduced from 2.5 to 0.5 g/day, and blood pressure normalized. Conclusion: This case demonstrates the potential for intensive lifestyle intervention to reverse diabetic nephropathy, highlighting the importance of a multidisciplinary approach in managing diabetes and preventing renal complications.

Improvement in symptoms of anxiety and depression in individuals with type 2 diabetes: retrospective analysis of an intensive lifestyle modification program

BackgroundType 2 diabetes (T2D) is a chronic metabolic disorder that has a notable influence on mental well-being, contributing to elevated morbidity and mortality rates. Depression and anxiety disorders are the most common mental health concerns among patients with T2D worldwide. Therefore, the present study aimed to assess the impact of an online intensive lifestyle intervention (ILI) on mental health outcomes (depression and anxiety) in patients with T2D in India.Materials and methodsThis retrospective pre-post analysis included adult patients (aged > 18 years) diagnosed with T2D who were enrolled in a diabetes management program in India between June 2021 and June 2023. The intervention consisted of lifestyle modifications such as a customized plant-based diet, regular physical activity, psychological support through group and individual therapy, and medical management. Data were extracted from the electronic database of the clinic, including anthropometry, medical history, biochemical parameters, symptoms of depression, and anxiety (assessed using the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorders-7 (GAD-7) scale) at the start and end of the six-month intervention period.ResultsOf the 1061 eligible patients (177 with prediabetes), 40.3% were female. The mean age, duration of diabetes, and HbA1c levels were 52 ± 10.4 years, 9.8 ± 7.8 years, and 8 ± 1.7%, respectively. The prevalence of symptoms of depression and anxiety (ranging from mild to severe) was 46% and 44.3%, respectively, which reduced to 28.7% and 29.2%, respectively, post-intervention.ConclusionIntegrated ILI successfully improved the symptoms of anxiety and depression, highlighting the importance of a multidisciplinary approach that includes diet, physical activity, psychological support, and medical management in enhancing mental health outcomes among patients with T2D. Future prospective studies are needed to explore the long-term effects of such interventions and develop effective strategies for promoting mental health in diverse populations.Trial registrationThe study was approved by the Freedom from Diabetes Research Foundation Institutional Ethics Committee (approval number FFDRF/IEC/2024/7) and registered in the Clinical Trials Registry of India (CTRI/2024/03/064596, registered on March 21, 2024).

8613 Diabetes remission: experience from a randomized control trial conducted in a tertiary care hospital in India

Abstract Disclosure: A.M. Chakraborty: None. R. Waila: None. S. Bhansali: None. H. Bhujade: None. N. Sachdeva: None. S. Bhadada: None. Introduction: The usual perception and interpretation of diabetes mellitus is that of an irreversible and chronic persistent disease with little scope for remission. Following the success of metabolic surgery and intensive lifestyle modification, it is time for pharmacotherapy to sept in. Methodology: It was a single-center, randomized controlled trial conducted in patients having HbA1c below 9 % at randomization and having a duration of diabetes less than 2 years. Patients with organ-threatening chronic diseases and severe diabetes-related complications have been excluded. Study populations have been randomized to 1:1 to receive pharmacotherapy with oral semaglutide, dapagliflozin, and metformin in one arm and vildagliptin, metformin, and titrated glimepiride in the control arm. Duration of therapy was 6 months including 2 months of up titration of semaglutide. Patients have been followed up for 3 months after stopping all therapy following 6 months of therapy. The primary outcome was to find out the remission rates in patients with Type 2 diabetes mellitus treated with a combination of oral Semaglutide and dapagliflozin on top of metformin monotherapy and to compare with the standard diabetes practice. The secondary outcome was to assess the anthropometric change and change in beta cell function parameters with a mixed meal tolerance test. Results: A total of 38 patients have completed therapy, 17 were in the trial arm and 21 in the control arm. Among 17 patients in the trial arm, all the patients were in remission as per the prespecified criteria. Among the patients who completed 6 months of follow-up (n-13), 11 patients (84%) maintained remission in the trial arm. The remission rate was 100% in the trial arm and 48% in the conventional arm (p<0.001) after 3 months and 84% and 27.7% in the trial arm and conventional arm respectively after 6 months of follow-up (p<0.05). Reduction in BMI (p <0.001) and percent body fat (p<0.01) and increase in disposition index after mixed meal tolerance test (p<0.01) was statistically related to remission. Conclusion: Remission of diabetes as defined by ADA in the consensus statement (HbA1c < 6.5 % without glucose-lowering therapy for at least 3 months) is a reality. It can be achieved by pharmacotherapy targeting body weight and adiposity. The main predictors of remission were a reduction of BMI and body fat and an increased disposition Index. Since it is an ongoing study, further follow-up is planned to determine the continuation of the remission phase among those who achieved remission with pharmacotherapy. Presentation: 6/3/2024

Camp-style lifestyle modification program (CAMP) for diabetes prevention among rural women with prior GDM: study protocol for a three-arm cluster hybrid type 2 randomized controlled trial

BackgroundIntensive lifestyle interventions were effective to reduce the risk of type 2 diabetes mellitus (T2DM) for women with gestational diabetes mellitus (GDM) history. However, reaching these mothers and maintaining participation in lifestyle interventions is suboptimal in real-world settings. Effective, feasible and sustainable new lifestyle interventions are needed. The objectives of this three-arm trial are to (1) compare diabetes risk outcomes of an evidence-based intensive lifestyle modification (ILSM) intervention, a camp-style lifestyle modification program (CAMP) intervention, and usual care among women with GDM history; and (2) evaluate the comparative efficacy of the CAMP versus ILSM intervention on implementation outcomes.MethodsA three-arm cluster randomized clinical trial (RCT) using a hybrid type 2 implementation design will be conducted in two counties in Hunan province in China. Six towns from each county will be randomly selected and assigned to CAMP, ILSM, and the usual care group (25 women from each of 12 towns, 100 women in each arm). The ILSM includes six biweekly in-person sessions and 3-month telephone health consultations, while the CAMP consists of a 2-day camp-based session and 3-month health consultations via a popular social media platform. Both interventions share the same session content, including six lifestyle skills. Efficacy (T2DM risk score and behavioral, anthropometric, psychosocial, and glycemic variables) and implementation outcomes (recruitment, acceptability, feasibility, fidelity, and cost-effectiveness) will be collected at baseline, 6-month, and 12-month. Pre-planned ANOVA F-test and generalized estimating equations will be included to test time-by-arm interactions.DiscussionThe CAMP intervention is expected to have better reach, better attendance, and comparable effectiveness in reducing the risk of T2DM, thus improving postpartum care for GDM in China. The delivery of a concentrated format supplemented with technology-based support may provide an efficient and effective delivery model for implementing maternal health promotion programs in primary care settings.Trial registrationRegistered in the Chinese Clinical Trial Registry (ChiCTR2200058150) on 31st March 2022.

Educational Model and Prevention on Prediabetes: A Systematic Review.

Prediabetes is a reversible condition before the onset of Type 2 Diabetes Mellitus. Untreated condition of prediabetes will develop into diabetes and its complications. The prevalence of prediabetes has been emerging worldwide and has a considerable socioeconomic impact. The current study reviews the roles of early detection, educational models, life modification, and prophylaxis of individuals with prediabetes in preventing the progression of prediabetes into Type 2 Diabetes Mellitus and complications in the future. This study included published articles from several electronic databases. The obtained articles were limited to March 2023. Articles that were not open access and not in Indonesian or English were excluded. The protocol for this study used the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020. Of 39627 articles, 39601 were excluded due to duplication and did not meet the eligibility criteria. At the final, there were 26 articles that were eligible for systematic review. Prevention of the development of prediabetes into diabetes is essential. A comprehensive understanding and training on intensive lifestyle modification protocols from local and national experts in diabetes prevention through digital-based education models and linguistically and culturally approach can be considered. Intensive lifestyle modification and pharmacological approaches may improve the outcome. Regular monitoring of glycemic control is also important for early diagnosis of diabetes, especially in patients with special conditions.

Emerging Therapeutics Targeting Cellular Stress Pathways to Mitigate End-Organ Damage in Type 1 Diabetes

Type 1 diabetes (T1D) is an autoimmune disease characterized by insulin deficiency and impaired glucose regulation. While daily insulin therapy is life-saving, many patients struggle to achieve optimal glycemic control, leading to microvascular complications affecting various organs, including the kidneys and the liver. This review aims to summarize the current state of knowledge regarding the pathogenesis of hepatic and renal complications in T1D, highlight recent advances in potential therapeutic targets, and provide evidence-based recommendations for mitigating end-organ damage. Chronic hyperglycemia drives diabetic complications through several interrelated mechanisms, including increased polyol pathway flux, advanced glycation end-product (AGE) formation, protein kinase C activation, and mitochondrial reactive oxygen species overproduction. In the liver, these processes contribute to non-alcoholic fatty liver disease, with up to 50% of T1D patients developing hepatic steatosis. Diabetic nephropathy, affecting 25%–40% of long-term T1D patients, is characterized by glomerular basement membrane thickening, mesangial expansion, and tubulointerstitial fibrosis. Recent innovations in T1D management include genomics and precision medicine approaches, gut microbiome modulation, nanomedicine, and artificial intelligence-driven glucose monitoring systems. Emerging immunotherapies aim to fundamentally modify the autoimmune response in T1D. Mitigating T1D complications requires intensive glycemic control, targeted pharmacotherapy, and lifestyle modifications. Emerging therapies and precision medicine approaches offer promising avenues. Ongoing research into molecular mechanisms remains crucial for developing novel interventions and improving long-term outcomes in T1D patients.

Approach to weight management in patients with advanced chronic kidney disease in a real-life clinical setting.

Excess adiposity represents a risk factor for chronic kidney disease (CKD) and progression to end-stage kidney disease. Anti-Obesity Medications (AOMs) are vastly underutilized in patients with advanced CKD because of concerns related to safety and efficacy. This study was conducted to evaluate the real-world approach to weight management and the efficacy and safety of AOMs in people with advanced CKD. This is a retrospective analysis of individuals with Body Mass Index (BMI)≥27kg/m2 and eGFR≤30mL/min/1.73m2 referred to an academic medical weight-management program between 01/2015 and 09/2022. Evaluation of weight-management approaches, body weight change, treatment-related side effects, and reasons for treatment discontinuation were reported. Eighty-nine patients met inclusion criteria, 16 were treated with intensive lifestyle modifications (ILM) alone and 73 with AOMs (all treated with glucagon-like peptide-1 receptor agonist [GLP1-RA] +/- other AOMs) along with ILM. Patients treated with AOMs had a longer duration of on-treatment follow-up (median 924days) compared to (93days) the ILM group. Over 75% of patients treated with AOMs lost ≥5% body weight versus 25% of those treated with ILM. Only 15% of patients treated with AOMs discontinued therapy due to treatment-related side effects. In patients with obesity and advanced CKD, GLP-1RA-based anti-obesity treatment was well-tolerated, effective, and led to durable weight reduction.

The importance of LDL-C lowering in atherosclerotic cardiovascular disease prevention: Lower for longer is better

Cumulative exposure to low-density lipoprotein cholesterol (LDL-C) is a key driver of atherosclerotic cardiovascular disease (ASCVD) risk. An armamentarium of therapies to achieve robust and sustained reduction in LDL-C can reduce ASCVD risk. The gold standard for LDL-C assessment is ultracentrifugation but in routine clinical practice LDL-C is usually calculated and the most accurate calculation is the Martin/Hopkins equation. For primary prevention, consideration of estimated ASCVD risk frames decision making regarding use of statins and other therapies, and tools such as risk enhancing factors and coronary artery calcium enable tailoring of risk assessment and decision making. In patients with diabetes, lipid lowering therapy is recommended in most patients to reduce ASCVD risk with an opportunity to tailor therapy based on other risk factors. Patients with primary hypercholesterolemia and familial hypercholesterolemia (FH) with baseline LDL-C greater than or equal to 190 mg/dL are at elevated risk, and LDL-C lowering with high-intensity statin therapy is often combined with non-statin therapies to prevent ASCVD. Secondary prevention of ASCVD, including in patients with prior myocardial infarction or stroke, requires intensive lipid lowering therapy and lifestyle modification approaches. There is no established LDL-C level below which benefit ceases or safety concerns arise. When further LDL-C lowering is required beyond lifestyle modifications and statin therapy, additional medications include oral ezetimibe and bempedoic acid, or injectables such as PCSK9 monoclonal antibodies or siRNA therapy. A novel agent that acts independently of hepatic LDL receptors is evinacumab, which is approved for patients with homozygous FH. Other emerging agents are targeted at Lp(a) and CETP. In light of the expanding lipid treatment landscape, this manuscript reviews the importance of early, intensive, and sustained LDL-C-lowering for primary and secondary prevention of ASCVD.

Non-alcoholic fatty liver disease and type 2 diabetes mellitus: diagnostic and therapeutic aspects. Review

The increase in the prevalence of non‑alcoholic fatty liver disease (NAFLD) occurs in parallel with the global epidemic of obesity and type 2 diabetes mellitus (T2DM) in the world. T2DM is an independent risk factor for the development of NAFLD. At the same time, researchers found that patients diagnosed with NAFLD have a two‑fold increased risk of developing T2DM. NAFLD is encompasses a spectrum of liver manifestations ranging from simple steatosis to nonalcoholic steatohepatitis (NASH), fibrosis and cirrhosis, which may ultimately progress to hepatocellular carcinoma. NASH is an aggressive form of NAFLD, associated with an increased risk of liver and non‑liver‑related mortality. Liver‑biopsy remains the gold standard for diagnosis, but the majority of patients liver damage can be diagnosed accurately by noninvasive methods.
 The presence of NAFLD in a patient with T2DM makes it difficult to achieve adequate glycemic control, deepens the manifestations of insulin resistance and atherogenic dyslipidemia, increases the risk of serious cardiovascular events and chronic kidney disease. Lifestyle modification and treatment of concomitant T2DM should be undertaken in all patients with NAFLD. To reduce the severity of liver steatosis, weight reduction by 3—5% is necessary, to reduce the inflammatory‑necrotic process, a more significant reduction may be required — up to 10% within 6—12 months. Physical activity increases the sensitivity of insulin receptors, and in combination with diet leads to a significantly significant improvement in biochemical and histological indicators in patients with NAFLD. Early identification and management of patients with intensive dietary and lifestyle modification are essential to prevent the development of advanced liver disease and its complications. Pharmacological therapy should be administered to patients with NASH purposed on the fibrosis inhibition, especially in case of the established predictors of high risk of disease progression (age >50 years, metabolic syndrome, T2DM, or increase in the activity of alanine aminotransferase), as well as to the patients with active NASH with high inflammatory activity.
 At the congress of the European Association for the Study of the Liver (EASL), which took place in Vienna on June 21—24, 2023, a new classification and nomenclature of NAFLD was adopted. It was proposed to replace the term «non‑alcoholic fatty liver disease» to the term «metabolic dysfunction‑associated steatotic liver disease» (MASLD). This diagnosis is established in patients with confirmed steatosis of the liver and one of five cardiometabolic risk factors: obesity, T2DM, insulin resistance, hyperlipidemia, atherosclerosis. The concept of «non‑alcoholic steatohepatitis» (NASH) has been changed to the concept of «metabolic dysfunction‑ associated steatohepatitis» (MASH). Coordination of the views of international and domestic experts in the field of studying this pathology will be important for clinical practice and scientific research.

Prediabetes increases the risk of major limb and cardiovascular events

BackgroundPrediabetes, an intermediate stage between normal blood sugar levels and a diabetes mellitus diagnosis, is increasing in prevalence. Severe prediabetes is associated with a similar risk of complications as diabetes, but its relationship with peripheral arterial disease remains underexplored.MethodsWe conducted a retrospective cohort study involving 36,950 adult patients, utilizing electronic medical records from the National Taiwan University Hospital between 2014 and 2019. We employed multivariable Cox regression and Kaplan–Meier analysis with the log-rank test to analyze major adverse limb events (MALE) and major adverse cardiovascular events (MACE) in relation to normal glucose regulation (NGR) and prediabetes.ResultsDuring the 131,783 person-years follow-up, 17,754 cases of prediabetes and 19,196 individuals with normal glucose regulation (NGR) were identified. Kaplan–Meier analysis revealed an increased incidence of both MALE and MACE in individuals with prediabetes. (log-rank p = 0.024 and < 0.001). Prediabetes exhibited a significant association with an elevated risk of MALE (adjusted hazard ratio (aHR) 1.26 [95% CI 1.10–1.46], p = 0.001) and MACE (aHR 1.46 [1.27–1.67], p < 0.001). Furthermore, in individuals with prediabetes, the elevation in the risk of MALE commenced before HbA1c levels surpassed 5.0% (for HbA1c 5.0-5.5%: aHR 1.78 (1.04–3.04), p = 0.036; HbA1c 5.5-6.0%: aHR 1.29 [1.06–1.58], p = 0.012; aHbA1c 6.0-6.5%: aHR 1.39 [1.14–1.70], p < 0.001). Similarly, the onset of increased MACE risk was observed when HbA1c levels exceeded 5.5% (for HbA1c 5.5–6.0%: aHR 1.67 [1.39–2.01], p < 0.001; HbA1c 6.0-6.5%: HR 2.10 [1.76–2.51], p < 0.001). Factors associated with both MALE and MACE in prediabetes include advanced age, male gender, higher body mass index, and a history of heart failure or atrial fibrillation.ConclusionWe demonstrated higher susceptibility to MALE and MACE in prediabetes compared to normoglycemic counterparts, notwithstanding lower HbA1c levels. Complications may manifest at an earlier prediabetes trajectory. Intensive lifestyle modification may improve the prognosis of severe prediabetes.

A closer look at weight loss interventions in primary care: a systematic review and meta-analysis

PurposeThe major aims were to quantify patient weight loss using various approaches adminstered by a primary care provider for at least 6 months and to unveil relevant contextual factors that could improve patient weight loss on a long-term basis.MethodsA systematic review and meta-analysis was conducted using Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Scopus, and Web of Science from inception to December 5, 2022. COVIDENCE systematic review software was used to identify and abstract data, as well as assess data quality and risk of bias.ResultsSeven studies included 2,187 people with obesity testing (1) anti-obesity medication (AOM), (2) AOM, intensive lifestyle counseling + meal replacements, and (3) physician training to better counsel patients on intensive lifestyle modification. Substantial heterogeneity in the outcomes was observed, as well as bias toward lack of published studies showing no effect. The random effect model estimated a treatment effect for the aggregate efficacy of primary care interventions −3.54 kg (95% CI: −5.61 kg to −1.47 kg). Interventions that included a medication component (alone or as part of a multipronged intervention) achieved a greater weight reduction by −2.94 kg (p &amp;lt; 0.0001). In all interventions, efficacy declined with time (reduction in weight loss by 0.53 kg per 6 months, 95% CI: 0.04–1.0 kg).ConclusionWeight loss interventions administered by a primary care provider can lead to modest weight loss. Weight loss is approximately doubled if anti-obesity medication is part of the treatment. Nevertheless, attenuated weight loss over time underscores the need for long-term treatment.Systematic review registration[https://www.crd.york.ac.uk/prospero/ CRD4202121242344], identifier (CRD42021242344).

SWAT 84: effects of same-day consent vs delayed consent on the recruitment and retention of trial participants—an observational SWAT

Background and aimThe recruitment process in a randomized trial can be challenging. Poor recruitment can have a negative impact on the allocated budget and estimated completion date of the study and may result in an underpowered study. We aimed to perform a Study Within A Trial (SWAT) to evaluate the impact of same-day consent or delayed consent on recruitment and retention in the host trial.MethodsThis SWAT is designed as a prospective cohort design. The host trial was a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification programme in participants with peripheral arterial disease. Researchers screened the participants for inclusion and exclusion criteria. Informed consents were obtained from the participants who were willing to participate in the study on a standardized consent form. Participants were given the option to consent on the same day or to delay their consent. Following the consent, the participants were allocated to two groups (same-day consent vs. delayed consent) based on pre-determined criteria for SWAT. One hundred sixteen participants were consented to take part in the host trial. Seventy-five participants were randomized to the host trial. The primary outcome was the proportion of participants who withdrew consent at the recruitment phase. Secondary outcomes were reasons for consent withdrawal and dropout, attrition rate, and adherence with the host trial intervention.ResultsThere was a significantly lower consent-withdrawal rate in same-day consent (17.4%, n = 8/46), compared to the delayed consent group (47.1%, n = 33/70), p = 0.001. There was a significantly lower dropout rate in participants randomized following same-day consent (10.5%, n = 4/38), compared to those randomized after delayed consent (29.7%, n = 11/37), p = 0.038. Transport was the main reason mentioned for consent withdrawal and dropout. In participants randomized to the host trial intervention arm, there was a significant difference in adherence (percentage of the 12-week programme completed) between same-day consent (96.7% ± 4.9) and delayed consent participants (86.4% ± 11.2), p = 0.003, as well as number of weeks completed (mean difference = − 1.547, 95% confidence intervals (− 2.237 to − 0.85)), p = 0.02.ConclusionThis SWAT found evidence that participants who gave consent on the same day seemed to have better adherence and fewer-withdrawal and dropout rates.SWAT registrationThe SWAT was registered on the Northern Ireland Network for Trials Methodology Research, SWAT 84.

1790-PUB: Effectiveness of an Intensive Lifestyle Modification Program on Type 2 Diabetes Remission in Indian Population

Background and Aim: Type 2 diabetes (T2D) remission is widely reported across the world. However, there are no large-scale cohort studies that report the effectiveness of lifestyle intervention on T2D remission, especially in Indian population. The study aimed to evaluate the effectiveness of a one-year lifestyle modification program-Holistic Transformation Program (HTP) on T2D remission in Indian population. Materials and methods: Patients with diagnosed T2D (&amp;gt;18 years of age) were recruited in a one-year intensive lifestyle modification program at the Freedom from Diabetes Clinic, Pune (India) between April and December 2021. The intervention included a customized vegan diet, exercises, stress management support, and medical management. Anthropometric and biochemical parameters were assessed with scheduled consults every 3 months. Remission was defined as HbA1c&amp;lt;48 mmol/mol for a minimum of 3 months without the use of antidiabetic medication. Results: The mean age and duration of diabetes were 52.0±10.6 years and 10.3±7.9 years, respectively (n=2764). Post-intervention, median weight, and HbA1c decreased significantly (weight-71 kgs to 67 kgs, p&amp;lt;0.01; HbA1c-7.5% to 6.6%) (p&amp;lt;0.05). Remission was seen in 837 (30.3%) patients. Significantly higher remission was seen in those with &amp;gt;15 kg weight loss and with diabetes duration of &amp;lt;10 years (p&amp;lt;0.05). Remission was highest in those who never started medication (with HbA1c&amp;gt;48 mmol/mol at baseline) (79%) followed by those only on oral hypoglycemic agents (31.7%). Improvement in HbA1c and weight loss were similar between patients on external insulin and/or OHA (p&amp;gt;0.1) indicating efficacy of the intervention irrespective of the medicine status at baseline. Conclusion: Our findings suggest that customized lifestyle intervention is beneficial in achieving T2D remission in Indian population. A one-year post-intervention follow-up is underway to understand the long-term effects of the intervention. Disclosure P. Tripathi: Board Member; Freedom from Diabetes Clinic. N.S. Kadam: Research Support; Freedom from Diabetes Clinic. B. Sharma: Research Support; Freedom From Diabetes clinic. A.R. Vyawahare: Research Support; Freedom From Diabetes. M.H. Ganla: Employee; Freedom from Diabetes Clinic. M. Das Biswas: Employee; Freedom from Diabetes Clinic. B.D. Saboo: None.

320-OR: ADA Presidents' Select Abstract: Risk Factors for Distal Symmetrical Polyneuropathy (DSPN) in the Diabetes Prevention Program (DPP) and the DPP Outcomes Study (DPPOS)

Objective: To evaluate how DSPN differs across the randomized DPP treatment groups and is associated with diabetes (DM) status, DM duration, and cumulative glycemic exposure. Methods: In the DPP, adults ≥25 years of age at high risk for DM (n=3234) were randomized to determine the effects of intensive lifestyle modification (ILS) or metformin (MET) compared to placebo (PLA) on incident diabetes. After DPP ended, participants were invited to join the DPPOS during which metformin was continued in those randomized to receive it. DSPN was rigorously assessed in 1,792 participants at DPPOS year 17 based on both symptoms and signs (pinprick, vibration, and monofilament). Multivariable logistic regression models were used to determine whether DSPN was associated with randomized treatment group, DM status and duration, and cumulative glycemic exposure. Results: At 21 years following DPP randomization, 66% had developed DM with median duration of 15 years. The prevalence of DSPN did not differ by DPP treatment group (21.5%, 21.5% and 21.9% in ILS, MET and PLA, respectively), but was slightly lower for those at risk for DM (19.6%) vs. those with DM (22.7%). There was a significant effect modification by age of the association between DPP treatment group and DSPN (p&amp;lt;0.05): the odds ratio (OR) for DSPN with ILS vs PLA decreased by 3.7% (95% CI 0.6-6.7) with each 1 year increase in age. MET vs. PLA was not associated with DSPN and age did not influence the null association. In models adjusted for treatment group, demographics, cardiometabolic risks, and low vitamin B12 or B12 supplement use, DSPN was associated with DM status (OR 1.40, p&amp;lt;0.001 vs. no DM), greater DM duration (OR 1.04 per 1 year, p&amp;lt;0.001), and higher time-weighted HbA1c (OR 1.85 per 1% increase, p&amp;lt;0.001). Conclusions: The likelihood of DSPN was higher for those with DM, longer DM duration, and higher cumulative glycemic exposure. Although ILS did not prevent DSPN overall, there were ILS benefits with increasing age. Disclosure C.Lee: Employee; Pfizer Inc. N.White: None. W.H.Herman: Advisory Panel; National Committee for Quality Assurance, Consultant; Merck Sharp &amp; Dohme Corp., Other Relationship; National Institutes of Health, American Diabetes Association. D.Research group: None. A.Ciarleglio: None. S.Edelstein: None. J.P.Crandall: Research Support; Abbott Diabetes. D.Dabelea: None. R.B.Goldberg: None. S.E.Kahn: Advisory Panel; Anji Pharmaceuticals, Bayer Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Merck &amp; Co., Inc., Other Relationship; Novo Nordisk. W.C.Knowler: None. M.Ma: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (UDK048489, UDK048339, UDK048377, UDK048349, UDK048381, UDK048468, UDK048434, UDK048485, UDK048375, UDK048514, UDK048437, UDK048413, UDK048411, UDK048406, UDK048380, UDK048397, UDK048412, UDK048404, UDK048387, UDK048407, UDK048443, UDK048400)

Intermittent Use of Continuous Glucose Monitoring: A New Paradigm in Treatment of Type 2 Diabetes.

To suggest how continuous glucose monitoring (CGM) may be used intermittently in individuals with type 2 diabetes (T2D). The use of CGM is largely in those with type 1 diabetes (T1D), in whom it makes sense to use CGM continuously as CGM provides a valuable tool to not only adjust their insulin doses but also to match it with their diet, physical activity, and other lifestyle modifications. In the case of T2D, however, especially for those not on insulin, the use of CGM may not be needed on a continuous basis. The use of CGM on an intermittent basis is rarely discussed in the literature. This article tries to provide clinical situations where CGM can be used intermittently. Intermittent use of CGM defined as the "use of CGM once in 2 or 3 months or a fixed frequency," and may be useful in several situations in those with T2D. We suggest the following indications for the intermittent use of CGM in T2D-newly diagnosed patients where treatment is being started, uncontrolled diabetes where treatment is being altered, starting intensive lifestyle modification, during infections, during preoperative control, in children and adolescents with T2D, as a motivational tool to improve behavioral modification, after metabolic surgery, and in patients on steroids, apart from other indications. Intermittent use of CGM in T2D can be useful in special situations and can also be cost saving particularly in resource-constrained regions of the world.

Weight-loss management after catheter ablation of atrial fibrillation

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Overweight and obesity are modifiable risk factors for atrial fibrillation (AF). Pulmonary vein isolation (PVI) is a cornerstone therapy of AF, however elevated body mass index (BMI) is associated with higher AF recurrence rate. Weight loss in patients with increased BMI can improve ablation outcomes, however data on weight loss management after PVI is lacking. Purpose To determine impact of weight loss in overweight and obese patients before PVI and to determine BMI trends after PVI. Methods Consecutive patients with baseline BMI &amp;gt;25 who underwent PVI were included into the study. All patients received comprehensive and intensive dietary and lifestyle modification recommendations. Anthropometric measurements were taken at initial visit (pre-PVI), on the day of ablation (PVI) and at the end of follow-up (post-PVI). Results 60 patients (25 female, age 59±11 years) were included into the study. Mean achieved weigh loss was before PVI was 2±4 kg (pre-PVI vs PVI, 85.3 kg vs 83.3 kg, p=0.31). During follow up lasting 15±13 months 29 patients (48%) remained AF-free. Seventeen patients (28%) gained ≥1kg from baseline and these patients were more likely to experience AF recurrence when compared to these patients who managed to sustained their weigh (76% vs 42%, p=0.0065). Thirty-one (52%) patients who managed to sustain weight loss ≥2kg from baseline were more likely to remain AF-free during follow-up (69% vs 35%, p=0.038). There was no statistically significant difference between weight at baseline vs after follow-up (pre-PVI vs post-PVI, 85.3 kg vs 83.4 kg, p=0.36). Conclusions A substantial portion of patients can experience weight regain after PVI. Weight regain is associated with increased risk of AF recurrence following catheter ablation of AF. In patients with elevated BMI periprocedural risk factor modification resulting in weight loss is associated with improved AF-free survival.

Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS): protocol of a prospective, multicentre, randomised, controlled trial

BackgroundThe superiority of balloon angioplasty plus aggressive medical management (AMM) to AMM alone for symptomatic intracranial artery stenosis (sICAS) on efficacy and safety profiles still lacks evidence from randomised controlled...

Global incidence and mortality trends of corpus uteri cancer and associations with gross domestic product, human development index, lifestyle, and metabolic risk factors.

To evaluate the worldwide distribution, risk factors, and temporal trends of corpus uteri cancer for different countries and age groups. Data relating to corpus uteri cancer in 2020 were retrieved from the Global Cancer Observatory database. Data from Cancer Incidence in Five Continents and the WHO mortality database were used for trend analysis. Age-standardized rates (ASR, per 100 000 persons) were calculated for incidence and mortality. Joinpoint regression analysis was used to estimate the 10-year annual average percent change (AAPC). A total of 417 367 new cases and 97 370 new deaths of corpus uteri cancer were reported globally in 2020. The highest incidence was observed in high-income countries. Higher ASR of mortality of corpus uteri cancer was associated with a higher gross domestic product per capita, higher Human Development Index, and higher prevalence of smoking, alcohol drinking, physical inactivity, obesity, hypertension, diabetes, and lipid disorders. There was a substantial increasing trend of corpus uteri cancer, with the largest AAPC in incidence found in Japan, followed by India, Chile, Korea, and Thailand. The incidence and mortality of corpus uteri cancer have been increasing substantially for the past 10 years. Intensive lifestyle modifications are needed, especially among younger women.

Abstract #1405583: Efficacy and Safety of Medical Weight Loss Interventions in Patients with Advanced Chronic Kidney Disease

The prevalence of obesity in patients with chronic kidney disease is higher than in general population. Obesity may limit accessibility to kidney transplantation, reduces quality of life and increases mortality rates, yet treatments for obesity are vastly underutilized in this population due to concerns related to feasibility and tolerability. This study aimed to evaluate the real-world efficacy and safety outcomes of medical weight loss therapies in patients with advanced chronic kidney disease. This is a retrospective analysis of all individuals with eGFR ≤30 mL/min/1.73m2 referred to an academic medical weight management clinic from 01/2015 through 09/2022. We report body weight changes through 60 months of follow-up, treatment-related side effects and reasons for treatment discontinuation. Overall 89 individuals met inclusion criteria, of which 16 individuals (average age 47.5±14.39 years, weight 114.1±24.27kg, 68.7% women, 75% on dialysis) were treated with intensive lifestyle modifications (ILM) alone and 73 individuals (average age 52.07±14.09 years, weight 120.3±21.63kg, 54.8% women, 53.4% on dialysis) were treated with anti-obesity medications (AOMs) along with ILM [all treated with a glucagon-like peptide-1 receptor agonist (GLP1-RA)+/-other AOMs]. Mean duration of follow-up was significantly longer in those treated with GLP1-RA compared to those treated with ILM: 1036.03±834.81 days versus 180.31±254.37 days, respectively, as such outcome data beyond 3 months of follow-up is only available for those treated with GLP1-RA. Percentage body weight change at 3 months was -0.83+/-11.6% for those treated with ILM and -4.03+/-5.4% for those treated with GLP1-RA (p=0.16 between groups). GLP1-RA group experienced the following percentage weight change from baseline: -5.1+/-6.3% at 6 months, -6.27+/-7.3% at 9 months, -6.44+/-7.8% at 12 months, -7.74+/-10.8% at 24 months, -9.38+/-13.8% at 36 months, -10.06+/-13.8% at 48 months and -7.19+/-14.6% at 60 months. At the time of data extraction 49.3% of patients were continuing treatment with GLP1-RA; 9.58% of individuals treated with GLP1-RA discontinued treatment due to gastrointestinal side effects, only one discontinued due to excessive weight loss. There were 3 events of pancreatitis in the GLP1-RA treated group and none in the ILM group. Of those treated with GLP1-RA, 21.91% reached the maximum dose licensed for obesity, 46.57% the maximum dose licensed for diabetes, and 31.51% were on lower doses. Most patients with advanced chronic kidney disease referred to a weight management program were treated with GLP1-RA based AOMs. These agents successfully induced and maintained weight change over a long period of follow-up, with few experiencing side effects and very few having to discontinue treatment due to side effects.

Effect of calorie restriction in comparison to usual diet or usual care on remission of type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials

BackgroundLimited evidence is available on the dose-dependent effects of calorie restriction in patients with type 2 diabetes. ObjectivesWe aimed to gather available evidence on the effect of calorie restriction on the management of type 2 diabetes. MethodsWe systematically searched PubMed, Scopus, CENTRAL, Web of Science, and gray literature until November 2022 for randomized trials >12 wk looking at the effect of a prespecified calorie-restricted diet on remission of type 2 diabetes. We performed random-effects meta-analyses to estimate the absolute effect (risk difference) at 6-mo (6 ± 3 mo) and 12-mo (12 ± 3 mo) follow-ups. Then, we performed dose–response meta-analyses to estimate the mean difference (MD) for the effects of calorie restriction on cardiometabolic outcomes. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to judge the certainty of evidence. ResultsTwenty-eight randomized trials with 6281 participants were included. Using a remission definition of an HbA1c level of <6.5% without antidiabetic medication use, calorie-restricted diets increased remission by 38 more per 100 patients (95% CI: 9 more, 67 more; n = 5 trials; GRADE = moderate) at 6 mo and by 13 more per 100 patients (95% CI: 10 more, 18 more; n = 4; GRADE = moderate) at 12 mo in comparison to usual diet or usual care. Using a definition of HbA1c of <6.5% after at least 2-mo cessation of antidiabetic medications, remission increased by 34 more per 100 patients (95% CI: 15 more, 53 more; n = 1; GRADE = very low) at 6 mo and by 16 more per 100 patients (95% CI: 4 more, 49 more; n = 2; GRADE = low) at 12 mo. At 6 mo, each 500-kcal/d decrease in energy intake resulted in clinically meaningful reductions in body weight (MD: −6.33 kg; 95% CI: −7.76, −4.90; n = 22; GRADE = high) and HbA1c (MD: −0.82%; 95% CI: −1.05, −0.59; n = 18; GRADE = high), which attenuated remarkably at 12 mo. ConclusionsCalorie-restricted diets may be effective intervention for type 2 diabetes remission, especially when coupled with an intensive lifestyle modification program.This systematic review was registered in PROSPERO as CRD42022300875 (https://www.crd.york.ac.uk/prospero/display_record.php?RecordID = 300875).Am J Clin Nutr 2023;xxx:xx–xx.