Percentage Change In Body Weight Research Articles

Dose-dependent reduction in body weight with LIK066 (licogliflozin) treatment in Japanese patients with obesity.

AimsLIK066 (licogliflozin) is a dual sodium glucose co‐transporter 1/2 inhibitor with potential benefits in weight loss. This study evaluated the efficacy, tolerability and safety of licogliflozin in Japanese adults with obesity.Materials and methodsThis study was a randomized, double‐blind, placebo‐controlled, dose‐finding study to evaluate the effect of licogliflozin (2.5, 10, 25 and 50 mg once daily) in 126 Japanese patients with obesity. The primary objective was to examine the dose–response relationship of licogliflozin treatment in body weight reduction relative to placebo at 12 weeks. The secondary objectives included assessment of responder rates, change in parameters related to complications, visceral and subcutaneous fat area, and safety during 12 weeks of treatment.ResultsThe placebo‐subtracted least square mean percentage change in body weight from baseline at week 12 was −1.99 (95% confidence interval −2.92, −0.21), −3.00 (−4.15, −1.70), −3.54 (−4.54, −2.26) and − 3.91% (−5.01, −2.77) in licogliflozin 2.5, 10, 25 and 50 mg once‐daily dose groups, respectively. The proportion of responders with ≥3% reduction in body weight in the licogliflozin 2.5, 10, 25 and 50 mg once‐daily dose groups were 15.8%, 55.6%, 50.0% and 56.7%, respectively, versus placebo [7.1%; P ≤0.002 for all except the 2.5 mg once‐daily group (P = 0.39)]. Dose‐dependent reductions were observed significantly in haemoglobin A1c, uric acid, fasting plasma glucose and potentially in the waist circumference, diastolic blood pressure and visceral fat area.ConclusionDual inhibition of SGLT1/2 with licogliflozin treatment induced a dose‐dependent reduction in body weight in Japanese patients with obesity. Treatment with licogliflozin was safe and well tolerated in this study. The study is registered with ClinicalTrials.gov (NCT03320941).

Hepatic proteome analysis reveals altered mitochondrial metabolism and suppressed acyl-CoA synthetase-1 in colon-26 tumor-induced cachexia.

Cachexia is a life-threatening complication of cancer traditionally characterized by weight loss and muscle dysfunction. Cachexia, however, is a systemic disease that also involves remodeling of nonmuscle organs. The liver exerts major control over systemic metabolism, yet its role in cancer cachexia is not well understood. To advance the understanding of how the liver contributes to cancer cachexia, we used quantitative proteomics and bioinformatics to identify hepatic pathways and cellular processes dysregulated in mice with moderate and severe colon-26 tumor-induced cachexia; ~300 differentially expressed proteins identified during the induction of moderate cachexia were also differentially regulated in the transition to severe cachexia. KEGG pathway enrichment revealed representation by oxidative phosphorylation, indicating altered hepatic mitochondrial function as a common feature across cachexia severity. Glycogen catabolism was also observed in cachexic livers along with decreased pyruvate dehydrogenase protein X component (Pdhx), increased lactate dehydrogenase A chain (Ldha), and increased lactate transporter Mct1. Together this suggests altered lactate metabolism and transport in cachexic livers, which may contribute to energetically inefficient interorgan lactate cycling. Acyl-CoA synthetase-1 (ACSL1), known for activating long-chain fatty acids, was decreased in moderate and severe cachexia based on LC-MS/MS analysis and immunoblotting. ACSL1 showed strong linear relationships with percent body weight change and muscle fiber size (R2 = 0.73-0.76, P < 0.01). Mitochondrial coupling efficiency, which is compromised in cachexic livers to potentially increase energy expenditure and weight loss, also showed a linear relationship with ACSL1. Findings suggest altered mitochondrial and substrate metabolism of the liver in cancer cachexia, and possible hepatic targets for intervention.

The WORD: Outcomes of a Behavioral Weight Loss Maintenance Effectiveness Trial in Rural Black Adults of Faith.

Rural black communities bear a disproportionate burden of obesity. To increase reach among underserved groups, community-based weight loss and maintenance interventions are crucial. The Diabetes Prevention Program (DPP) was adapted for rural black adults of faith to create The Wholeness, Oneness, Righteousness, Deliverance (WORD) trial, a group-based, community health worker-delivered weight loss intervention. A Weight Loss Only arm (16 sessions) was compared with a Weight Loss + Maintenance arm (16 + 12 sessions) in a cluster randomized controlled trial of 31 churches (n = 440). Weight and related behaviors were assessed at 0, 6, 12, and 18 months. The WORD produced weight loss from baseline to 6 months (percentage body weight change-2.47 [-3.13 to -1.80]). Among those who lost 5% of their baseline weight, there was a statistical trend of lower weight regain in the Weight Loss + Maintenance arm compared with control. Maintenance arm participants reported higher activity at 12 months. There were no between-arm differences at 18 months. The WORD produced weight loss from baseline to 6 months on par with that produced by other DPP adaptations for black communities, including adaptations using health professionals. Weight regain was also consistent with that reported in prior literature. Continuing sessions as part of the church's mission may foster adoption of DPP-based weight loss programs.

Examination Regarding Change of Differences in the Diet Effect with Age: Analysis Based on Wavelet Interpolation Model

During diets, people basically try to change their living habits to lose weight, such as restricting caloric intake and increasing energy consumption through exercise and activity. This could truly be considered a hostile act against corpulence in modern society. For many women in particular, the act of dieting is essentially wishful thinking in their daily lives, and selecting easy diet food would seem to be an obvious way to achieve this wish. However, while the diet effect must be clear when selecting better diet products, there have been no findings on diet effect that consider the effects of age. In this study, we used product evaluation, sex, age, height, body weight before use, body weight after use, duration of use, and other factors in data from the T. M. Community Co., Ltd. (TMC) review site “Diet Cafe,” which specializes in diet products. We analyzed the changes in the diet effect with age by applying the wavelet interpolation model to the change in body weight and the percentage change in body weight in subjects aged from the 10s to 60s. In addition, with the curves describing the amount and percentage of the change in body weight, we investigated the inflection point (critical point) in the diet effect with age by deriving velocity curves as differentials. The WIM was applied to the age-related changes in the size of the diet effect, and the identification of the age of 30 as a critical point in the diet effect from the behavior of the velocity curve may be considered a finding derived for the first time. The slowing of the velocity then becomes consistent about 10 years after the critical point, at around the age of 40, from which it may be proposed that the age of 40 is a true transition phase for women.

Antimalarial Activities of Hydromethanolic Crude Extract and Chloroform Fraction of Gardenia ternifolia Leaves in Plasmodium berghei Infected Mice.

Background Gardenia ternifolia is utilized in traditional medicine of Ethiopia for malaria treatment and possessing in vitro antimalarial activity. However, no in vivo study was conducted to substantiate the claim. The aim of this study was to judge the antimalarial activity of Gardenia ternifolia extract in vivo in Plasmodium berghei-infected mice. Methods Plasmodium berghei was inoculated to healthy mice, and hydromethanolic crude extract and chloroform fraction of G. ternifolia leaves at 100 mg/kg/day, 200 mg/kg/day, and 400 mg/kg/day were administered. Percent parasitemia inhibition, percent change in bodyweight, hemoglobin level, and mean survival time were determined. Data were analyzed using one-way ANOVA followed by post hoc Tukey HSD test with IBM SPSS software version 20.0 statistical package and P < 0.05 considered as statistically significant. Results The chemosuppressive test of hydromethanolic crude extract at 100 mg/kg/day, 200 mg/kg/day, and 400 mg/kg/day ranged from 27.09% to 67.72%, and chloroform fraction had 35.21%–78.19% parasitemia suppression, respectively. For curative test on day 5, hydromethanolic crude extract at 100 mg/kg/day, 200 mg/kg/day, and 400 mg/kg/day ranged from 25.58% to 48.76%, chloroform fraction at 100 mg/kg/day, 200 mg/kg/day, and 400 mg/kg/day and chloroquine base at 10 mg/kg showed 46.36%–74.42% and 92.87% percent parasitemia inhibition, respectively, and also the results to both tests were highly significant (P < 0.001) compared to the negative control. Maximum effects on chemosuppressive, curative, prevention of weight loss, and reduction in hemoglobin were observed at higher doses of the hydromethanolic crude extract and chloroform fraction. Conclusion From this study, hydromethanolic crude extract and chloroform fraction of G. ternifolia leaves have shown promising antimalarial activity. The findings support the traditional claim of G. ternifolia leaves for malaria treatment; however, species variation could also limit such a straightforward extrapolation of the findings of this study in humans.

Two-Year Weight Loss but Not Body Mass Index Predicts Mortality and Disability in an Older Japanese Community-Dwelling Population

ObjectivePrevious studies in older populations have shown a cardioprotective effect for obesity, an observation known as the obesity paradox. However, whether a decrease or increase in body weight over a certain period affects disability and mortality in older adults remains unknown. Hence, we examined whether the percent body weight change can predict the risk of mortality and disability in older Japanese adults. DesignWe performed a longitudinal prospective cohort study. Setting and participantsWe investigated 1229 community-dwelling older adults (aged ≥65 years) living in Japan. MethodsParticipants were divided into 3 groups (weight loss, stable weight, and weight gain) based on percentage body weight change (using 1 standard deviation from the mean as cutoff points) between 2011 and 2013. Death and disability incidences were monitored between April 2013 and March 2016. Disability was defined as the need for new long-term care insurance (LTCI). ResultsThe rates of death and new LTCI requests over the 3-year follow-up were 2.4% and 4.7%, respectively. The weight loss group (reduction >4.8%) had a 5.0% death rate and an 11.1% new LTCI rate, which were significantly higher than those in the stable weight (1.6% and 3.8%, respectively) and weight gain (ie, gain >3.1%) groups (3.9% and 4.7%, respectively). Cox regression analysis confirmed a higher risk for death [hazard ratio (HR) = 3.10, 95% confidence interval (CI) = 1.31-7.31] and new LTCI requests (HR = 3.03, 95% CI = 1.69-5.43) only in the weight loss group. The body mass index did not significantly influence the risk of death or disability. Conclusions/ImplicationsWeight loss over 2 years but not body mass index was associated with a higher death and disability risk during the subsequent 3-year follow-up period among older participants. Weight change surveillance can improve the quality of health care by early identifying frailty and death risk population.

Factors associated with minimal changes in countermovement jump performance throughout a competitive division I collegiate basketball season

ABSTRACTThe purpose of the study was to assess factors that contribute to countermovement jump (CMJ) performance in women’s basketball athletes. Thirteen female athletes participated and were tested for maximal oxygen uptake (VO2max) and heart rate (HRmax). Athletes were monitored, daily for a total of 21 weeks with heart rate-based wearable devices and CMJ performance and body weight were tested weekly after one day of recovery. 3-jump average height (CMJavg), maximum height jump (CMJmax), and CMJ power (Watts) were calculated and recorded. Playing intensities >85% HRmax, HRavg, HRmax and training load were averaged for three consecutive days prior to the recovery day. After the season, data was grouped as changes in CMJ power from week one: Large (≤ −4.39% change), Moderate (−4.4% to −0.62% change), and Minimal (≥ −0.61% change) changes. Fixed-effects models revealed a main effect of group (p ≤ 0.05) for CMJavg, CMJmax, VO2max, weekly percent changes in body weight and for 3-day training load, HRavg, and playing time at >85% HRmax. When athletes experienced minimal changes in CMJ performance, relative to large changes, they produced greater power, jumped higher, avoided negative changes in weekly body weight, had a greater preseason VO2max and 3-day average workloads appeared to have an impact on CMJ performance

Personalized intervention to improve stress and sleep patterns for glycemic control and weight management in obese Emirati patients with type 2 diabetes: a randomized controlled clinical trial.

Background: There is growing evidence that stress and sleep deprivation are involved in development of type 2 diabetes (T2DM). The latter is one of the most challenging health problems in the UAE. Therefore, the present study aimed to investigate the effects of personalized intervention on glycemic and weight control in Emirati patients with T2DM. The intervention involved assessment and modification of stress levels and sleep patterns.Methods: This was a randomized controlled study conducted on 51 Emirati patients with T2DM (age 18–60 years, body-mass index (BMI) ≥25 kg/m2): those in the intervention group who completed the trial numbered 18 and those in the control group who completed the trial numbered 17. Heart-rate variability was used for real-life and long-term assessments of stress, sleep, and recovery. Body weight, BMI, HbA1c and lipid profile were included in the investigation. The National Clinical Trial identifier number is NCT03644134.Results: Percentage change in body weight was significantly greater (P<0.05) in the intervention group (–3.2±2.9) than the control group (–0.02). Percentage change in the BMI of the intervention group was –4.50±5.9, while the control group exhibited less change in BMI (–0.0003±3.3, P<0.05). In addition, a significant reduction in HbA1c was observed in the intervention group (–5.3±15.7) and an increase of 9.9±13.1 was observed in the control group (P<0.01).Conclusion: The findings of the present study show that personalized approaches that reduce stress levels, increase recovery levels, and promote healthy sleep habits play an important role in weight management and glycemic control in T2DM.

Unrecognized fluid overload during induction therapy increases morbidity in patients with acute promyelocytic leukemia.

The combination of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) has proven to be the most effective therapy for patients with acute promyelocytic leukemia (APL). The majority of the morbidity and mortality from APL therapy occur during the induction phase. The objective of the current study was to identify the risk factors associated with transfer to the intensive care unit (ICU) and endotracheal intubation during induction therapy in patients with APL. The authors analyzed the clinical characteristics of 187 patients with newly diagnosed APL who were treated with ATRA and ATO with or without gemtuzumab ozogamicin. The authors documented the percentage change in body weight from baseline to the maximum recorded weight during induction or to the day of ICU transfer. A total of 18 patients (10%) who initiated therapy with ATRA and ATO on a regular hospital floor required transfer to the ICU after a median of 12days of induction therapy. The median volume of transfusions was 4350mL (range, 60-30,750mL). The volume of transfusions was the main factor associated with the risk of ICU transfer (odds ratio, 4.1; P<.001). Of the 18 patients transferred to the ICU, 10 patients (5%) required intubation. An increase in the total volume of transfusions, increase in weight ≥10% during induction therapy, and a plasma albumin level ≤3.2g/dL at the time of diagnosis were found to be associated with an increased risk of endotracheal intubation. Large volumes of blood product transfusions and unrecognized fluid overload during induction are associated with ICU transfer and endotracheal intubation in patients with APL. These can be prevented by limiting the amount of transfusions, careful monitoring for subtle signs of fluid overload, and early intervention with aggressive diuretic therapy.

Real-World Clinical Effectiveness of Liraglutide 3.0 mg for Weight Management in Canada.

ObjectiveReal‐world clinical effectiveness of liraglutide 3.0 mg, in combination with diet and exercise, was investigated 4 and 6 months post initiation. Changes in absolute and percent body weight were examined from baseline.MethodsA cohort of liraglutide 3.0 mg initiators in 2015 and 2016 was identified from six Canadian weight‐management clinics. Post initiation values at 4 and 6 months were compared with baseline values using a paired t test.ResultsThe full cohort consisted of 311 participants, with 210 in the ≥ 4‐month persistence group and 167 in the ≥ 6‐month persistence group. Average baseline BMI was 40.7 kg/m2, and weight was 114.8 kg. There was a significant change in body weight 6 and 4 months after initiation of treatment in persistent subjects (≥ 6‐month: −8.0 kg, P < 0.001; ≥ 4‐month: −7.0 kg, P < 0.001) and All Subjects, regardless of persistence (−7.3 kg; P < 0.001). Percentage change in body weight from baseline was −7.1% in the ≥ 6‐month group and −6.3% in the ≥ 4‐month group, and All Subjects lost 6.5% body weight. Of participants in the ≥ 6‐month group, 64.10% and 34.5% lost ≥ 5% and > 10% body weight, respectively.ConclusionsIn a real‐world setting, liraglutide 3.0 mg, when combined with diet and exercise, was associated with clinically meaningful weight loss.

Predicting the Magnitudes of Hyperthermia and Hypohydration during Prolonged Exposures to Warm and Very Humid Environments

In the event of a disabled submarine a pressurized rescue module (PRM) may be deployed. Safe deployment of the PRM depends on understanding the challenges should failures occur. If a PRM were to become disabled, temperature and humidity are predicted to rise quickly, and submariners may need to endure environments approaching 35°C, 95% relative humidity (RH) until rescued. Models predicting increases in core temperature (i.e., hyperthermia) and the magnitude of hypohydration incurred over 24 h in 95% RH environments yield physiologically impossible outcomes at ambient temperatures ≥32°C. Thus, it is not possible to accurately predict the magnitudes of hyperthermia and hypohydration during prolonged exposures to warm and very humid environments. By extension, the fluid prescription required to prevent unsafe levels of hypohydration, defined as a loss of body weight &gt;4%, in a disabled PRM is also unknown.PurposeTest the hypothesis that the predicted magnitudes of hyperthermia and hypohydration during a 24 h exposure to a 95% RH environment are dependent on ambient temperature.Methods10 healthy males (23 ± 3 y) sat in a 95 ± 2% RH normobaric environment for 8 h on three occasions separated by ≥7 days. Trials differed by temperature (32 ± 0°C, 33 ± 0°C, 35 ± 0°C). The order of the trials was randomly assigned. Subjects were not allowed to eat or drink throughout. Core temperature (telemetry pill) and percent changes in body weight (%ΔBW), an index of changes in total body water, were measured every hour. Sweat rate was calculated from %ΔBW. Linear regression models were fit to core temperature (over the final 3 h of exposure), and %ΔBW and sweat rate (over the entire 8 h exposure) over time for each subject. The resulting equations were used to predict the magnitudes of hyperthermia, %ΔBW, and sweat losses for up to 24 h. The volume of fluid required to prevent &gt;4% loss of body weight was calculated accordingly. Data are presented as mean ± SD.ResultsAt the end of the 8 h exposure, core temperature was higher in 35°C (38.0 ± 0.3°C, P&lt;0.01) compared to 32°C (37.6 ± 0.2°C) and 33°C (37.5 ± 0.2°C). At this time, %ΔBW was greater in 35°C (−2.0 ± 0.5%, P&lt;0.01) compared to 32°C (−1.5 ± 0.5%) and 33°C (−1.7 ± 0.4%). At 24 h, predicted core temperature was higher in 35°C (39.0 ± 1.1°C, P&lt;0.01) compared to 32°C (37.7 ± 1.0°C) and 33°C (37.8 ± 0.9°C), and the predicted %ΔBW was greater in 35°C (−6.1 ± 1.2%, P&lt;0.01) compared to 32°C (−4.5 ± 1.2%) and 33°C (−5.3 ± 1.3%). Predicted sweat loss at 24 h was greater in 35°C (−5.2 ± 1.4 L, P&lt;0.01) compared to 32°C (−3.8 ± 1.6 L) and 33°C (−4.4 ± 1.1 L). The predicted fluid prescription required to prevent &gt;4% loss of body weight was greater in 35°C (1.8 ± 0.9 L) compared to 32°C (0.7 ± 0.8 L, P&lt;0.02), and 33°C (1.0 ± 0.8 L, P=0.06).ConclusionIn a 95% RH environment, the magnitudes of hyperthermia and hypohydration predicted to occur during a 24 h exposure are dependent on ambient temperature. Moreover, the volume of fluid required to prevent &gt;4% loss in body weight during a 24 h exposure in ambient temperatures ≤35°C is ~1.8 L.Support or Funding InformationNaval Sea Systems Command Award N00024‐18‐C‐4316.This abstract is from the Experimental Biology 2019 Meeting. There is no full text article associated with this abstract published in The FASEB Journal.

Effects of an immunomodulatory feed additive on body weight, production parameters, blood metabolites, and health in multiparous transition Holstein cows.

The study investigated the impact of feeding OmniGen-AF® (OG; Phibro Animal Health, Quincy, IL) from dry-off to week 4 of lactation at two doses on production performance and metabolic adaptation of multiparous Holstein cows. Forty-eight cows were blocked and assigned randomly to three treatments: OG was fed at 0g/head/day (CON), 60g/head/day (OG60), or 90g/head/day (OG90). No difference was observed in dry matter intake (DMI) throughout the experiment, whereas feeding OG tended to decrease the percentage body weight change (PWC) on week 2. Although colostrum yield was not affected by treatment, colostrum IgG production of OG90 tended to be higher than that of CON. OG supplementation did not affect overall milking performance but decreased milk SCC during the first 4weeks of lactation. In prepartum, OG supplementation decreased the concentrations of serum albumin and calcium, and increased serum globulin. OG supplementation tended to increase serum total protein, globulin, and calcium contents postpartum. Furthermore, reduced incidence of mastitis and udder edema were observed. In conclusion, supplementing cows with OG from dry-off period reduces or modulates the inflammation responses associated with parturition, potentially resulting in improved postpartum health, while feeding OG more than 60g/head/day did not warrant further benefits.

Effectiveness of a Total Meal Replacement Program (OPTIFAST Program) on Weight Loss: Results from the OPTIWIN Study.

ObjectiveThe aim of this study was to test the effectiveness of the OPTIFAST program (OP), a total meal replacement dietary intervention, compared with a food‐based (FB) dietary plan for weight loss.MethodsParticipants with BMI 30 to 55 kg/m2, age 18 to 70 years old, were randomized to OP or FB dietary and lifestyle interventions for 26 weeks, followed by a weight‐maintenance phase. Outcomes were percent change in body weight (%WL) from baseline to weeks 26 and 52, associated changes in body composition (using dual energy x‐ray absorptiometry), and adverse events. Primary analysis used repeated‐measures multivariable linear mixed models to compare outcomes between groups in a modified intention‐to‐treat fashion (mITT).ResultsA total of 273 participants (83% of randomized; 135 OP, 138 FB) made up the mITT population. Mean age was 47.1 ± 11.2 years; 82% were female and 71% non‐Hispanic white. Baseline BMI was 38.8 ± 5.9 kg/m2. At 26 weeks, OP %WL was 12.4% ± 0.6% versus 6.0% ± 0.6% in FB (P < 0.001). At 52 weeks, OP %WL was 10.5% ± 0.6% versus 5.5% ± 0.6% in FB (P < 0.001). Fat mass loss was greater for OP; lean mass loss was proportional to total weight loss. There was no difference in serious adverse event rates between groups.ConclusionsCompared with an FB approach, OP was more effective with greater sustained weight loss.

Abstract 17193: Effect of Long Term Canagliflozin Use on Body Weight and Blood Pressure: A Systematic Review and Meta-Analysis

Introduction: Although Canagliflozin, an FDA-approved sodium-glucose cotransporter 2 inhibitor (SGLT2i), is known to reduce body weight and blood pressure (BP) in the short-term, it is unclear whether this effect persists in the long-term. Furthermore, it remains uncertain whether the reduction in BP and body weight is dose-dependent. Objective: To conduct a meta-analysis to study the effects of long term Canagliflozin use on BP and body weight in type 2 diabetes mellitus (T2DM) patients and stratify the results by dosage. Methods: MEDLINE and Scopus were queried in May 2018 for randomized controlled trials (RCTs) of Canagliflozin that had a follow-up period of at least one year and reported change in BP and percentage change in body weight. Data from included studies were pooled using a random effects model and results were presented as weighted mean differences (WMDs) with 95% confidence intervals (CIs). Subgroup analysis according to dosage (100mg/300mg) was performed. Chi-squared test was conducted to test for subgroup differences. Results: Five RCTs (N=15,230 participants) were included in the final analysis. Canagliflozin also led to significant reduction in body weight when compared to controls (WMD: -3.32% [-4.04, -2.60]; p&lt;0.001); however, this effect was not found to be dose-dependent (p=0.76). Both systolic (WMD: -4.40 mmHg [-5.18, -3.62]; p&lt;0.001) and diastolic (WMD: -1.68 mmHg [-2.14, -1.23]; p&lt;0.001) BP were significantly lower with long-term canagliflozin use, when compared to placebo (Figure 1). This effect was significantly stronger in the 300mg subgroup, when compared to the 100mg subgroup for both systolic (p=0.02) and diastolic (p=0.01) BP. There was no significant change in the risk of hypotension with the use of canagliflozin (Odds ratio: 1.59 [0.80, 3.19]; p=0.19). Conclusion: Long-term Canagliflozin is associated with reduced body weight and may be one mechanism for the beneficial BP response observed . Favorable changes in body weight and BP may be responsible for improved cardiovascular outcomes in T2DM patients with Canagliflozin.

PSY10 - Real-World Clinical Effectiveness of Liraglutide 3.0 mg for Weight Management in Canada

Real-world clinical effectiveness of liraglutide 3.0 mg, in combination with diet and exercise, was investigated at 4 and 6 months post-initiation. Changes in absolute and percent body weight, and in cardiometabolic markers, were examined from baseline. Using a database of de-identified electronic medical records from 6 Canadian weight management clinics, a cohort of liraglutide 3.0 mg initiators during 2015-2016 was identified. Post-initiation values at 4 and 6 months were compared to respective baseline values using a paired t-test. The full cohort consisted of 311 subjects, with 210 subjects in the ≥4months and 167 subjects in the ≥6months persistence groups. For all subjects, average age was 49.7 and subjects were predominantly white (77.5%) and female (83.0%). Average BMI was 40.7 kg/m2, and weight was 114.8 kg. At baseline, 74.9%, 19.9% and 5.1% of subjects had normoglycemia, prediabetes, and diabetes, respectively. Average baseline values for HbA1c and blood pressure were 5.8% and 127/77 mmHg. There was a significant change in body weight 6 months after initiation of treatment in persistent subjects (≥6months: -8.1 kg, p<0.001). Weight loss was also significant for subjects persistent on treatment for ≥4months (-6.9 kg, p<0.001) and in all subjects, regardless of persistence (-7.5 kg, p-value<0.001). Percentage change in body weight from baseline for the ≥6months group was -7.1%, with 63.4% and 35.2% of subjects having lost ≥5% and >10% body weight, respectively. Overall percentage change in body weight was also observed in the ≥4months group (-6.2%) and in all subjects (-6.6%). For the ≥6months treatment group, there was a statistically significant change in HbA1c (-0.35%, p<0.001) and SBP (-3.0 mmHg, p<0.01), but not DBP (0.1 mmHg, p=0.90). In a real-world setting, liraglutide 3.0 mg, when combined with diet and exercise, was associated with clinically meaningful weight loss and with improvements in cardiometabolic markers.

Risk Factors for Weight Loss 1 Year After Esophagectomy and Gastric Pull-up for Esophageal Cancer

BackgroundLoss of body weight is regarded as a marker of malnutrition after esophagectomy. This study investigated changes in body weight and risk factors for weight loss after esophagectomy for esophageal cancer. MethodsWe retrospectively reviewed records of 181 patients who underwent esophagectomy and gastric pull-up from 2012 to June 2016. Patients with operative mortality and recurrences were excluded. Percent change in body weight was defined as change in body weight (%)=(1-year body weight−preoperative body weight)×100/preoperative body weight. ResultsMean age of patients was 62.98±8.23 years with 164 men (90.6%). Mean preoperative body weight was 63.12±9.42 kg, and body weight at 1 year was 56.04±8.59 kg. Mean change in body weight was −10.95±7.50%, and 98 (54.1%) patients showed weight loss more than 10% compared to initial body weight. Univariable analysis showed that initial body weight, narrow gastric tube, thoracotomy, laparotomy, and postoperative vocal cord palsy (VCP) were related to more than 10% weight loss. Multivariable analysis showed that initial body weight (odds ratio [OR]=1.041, p=0.031) and postoperative VCP (OR=2.772, p=0.025) were adverse risk factors for weight loss 1 year after esophagectomy, whereas conduit type, route of reconstruction, postoperative complications, anastomotic complications, minimally invasive esophagectomy, and adjuvant therapy were not. ConclusionsInitial body weight and postoperative VCP were related to weight loss. Patients with VCP need additional nutritional monitoring and support.

S226. A STUDY COMPARING WEIGHT GAIN FROM ALKS 3831 TO OLANZAPINE IN EARLY-ILLNESS YOUNG ADULTS WITH SCHIZOPHRENIFORM, SCHIZOPHRENIA, OR BIPOLAR I DISORDER

BackgroundOptimal pharmacological efficacy is crucial in first-episode and early-episode schizophrenia and bipolar I disorder. Olanzapine (OLZ) is a highly efficacious antipsychotic indicated for the treatment of schizophrenia and bipolar I disorder. However, the clinical utility of OLZ may be limited by a propensity to cause significant weight gain and increased metabolic side effects, especially for patients early in the course of their illness. ALKS 3831 is composed of a flexible dose of olanzapine (OLZ) and a fixed dose of 10 mg of samidorphan (SAM), formulated as a bilayer tablet. ALKS 3831 has been shown in Phase 1 and Phase 2 studies to result in significantly less weight gain than OLZ while delivering equivalent antipsychotic efficacy. This Phase 3, 12-week study, is designed to evaluate the effect of ALKS 3831 on body weight in young adults early in the course of diagnosis of a serious mental illness, including a schizophreniform, schizophrenia, or bipolar I disorder diagnosis.MethodsThis is an international (Austria, Germany, Ireland, Israel, Italy, Poland, Spain, UK, and USA) two-arm, double-blind, active-comparator–controlled, multicentre study (planned N=250) that started enrollment in 2017. Key inclusion criteria are a primary diagnosis of schizophreniform disorder, schizophrenia, or bipolar I disorder; a body-mass index (BMI) of ≥18.0 and ≤27.0 kg/m2; and meeting specific criteria for duration of illness and prior antipsychotic exposure. Patients with a bipolar I diagnosis must be in the manic phase. In the US sites, men and women must be aged ≥16 to <40 years at screening, and in Europe, aged ≥18 to <40 years. Exclusion criteria include diagnosis of additional psychiatric conditions and use of prohibited drugs.ResultsPatients will be randomised 1:1 to receive either OLZ or ALKS 3831 treatment for 12 weeks. ALKS 3831 (OLZ + SAM) and matched OLZ + placebo (OLZ + PBO) will be provided as bilayer tablets to be taken by mouth once daily and doses will include ALKS 3831 (OLZ/SAM) 5/10 mg, 10/10 mg, 15/10 mg, 20/10 mg, or (OLZ/PBO) 5 mg, 10 mg, 15 mg, or 20 mg. The primary endpoint will be percent change in body weight from baseline to Week 12. Secondary and exploratory endpoints will include the proportion of patients who gain ≥7% and ≥10% of baseline body weight, metabolic parameters (change in fasting lipids and glucose), body composition measured through bioimpedance, clinical global impression, and safety, pharmacokinetic, and pharmacodynamic parameters. Patients will be offered a supportive clinical care programme during the 12-week treatment period, and also receive a daily medication-adherence monitoring and reminder system (via smartphones).DiscussionPatients who complete the study will have the option to participate in an open-label 2-year extension of ALKS 3831 (based on clinician and patient decision).EudraCT number: 2017-000497-11; ClinicalTrials.gov identifier: NCT03187769

Quantification of Biological Responses as Predictors of Cognitive Outcome after Developmental TBI.

Successful translational studies within the field of Traumatic Brain Injury (TBI) are concerned with determining reliable markers of injury outcome at chronic time points. Determination of injury severity following Fluid Percussion Injury (FPI) has long been limited to the measured atmospheric pressure associated with the delivered pulse. Duration of unresponsiveness to toe pinch (unconsciousness) was next introduced as an extra marker of injury severity. The current study is an effort to assess the utilization of acute injury-induced biological responses (duration of toe pinch unresponsiveness, percent body weight change, quantification of brain edema, and apnea duration) to predict cognitive performance at a subacute time point following developmental brain injury. Cognitive performance, when measured at a subacute phase, after developmental FPI was negatively correlated with the following variables, duration of toe pinch unresponsiveness, percent weight change, and quantified level of brain edema. These finding suggest the potential utilization of reliable severity assessment of injury-induced biological responses in determining outcome measures at subacute time points.

Effectiveness of an Interprofessional Glycemic Optimization Clinic on Preoperative Glycated Hemoglobin Levels for Adult Patients With Type 2 Diabetes Undergoing Bariatric Surgery.

Bariatric surgery is an effective treatment for patients with type 2 diabetes and refractory obesity; however, many patients have nonoptimal glycemic control preoperatively. We created an interprofessional bariatric glycemic optimization clinic. Patients were seen monthly and received weekly phone calls. We analyzed the effectiveness in assisting patients reach a preoperative glycated hemoglobin (A1C) level of <7.5%. Data were analyzed for the first 75 patients. The primary outcome measure was percentage of patients reaching target A1C levels. Mean age was 51±8.3 years; 64% were women. Mean baseline weight was 134.4±29.2 kg. Baseline body mass index was 48.2±8.3 kg/m2. Duration of diabetes was 9±7.9 years. Baseline A1C level was 9.0±1.2%. Number of antihyperglycemic agents at baseline was 2.7±0.96. Seventy-five percent reached a target A1C level of ≤7.5%, 92% reached a target of ≤8.0% and 95% reached a target of ≤8.5%; 32% had achieved A1C levels ≤7.5% at 1 month, 59% at 2 months, 70% at 3 months, 73% at 4 months and 75% at 5 months. Mean number of antihyperglycemic agents at target A1C levels was 3.6±1.1. Mean absolute decrease in A1C levels from baseline to target A1C levels was 1.7±1.2. Mean absolute change in weight was -1.9±8.0 kg. Percent change in body weight from baseline to target A1C level was -1.3±4.9%. Glycemic optimization for candidates with diabetes for bariatric surgery is possible in a short time by an interprofessional diabetes team and without weight gain. Further research is needed to determine whether better preoperative glycemic control improves bariatric surgery outcomes.

Bisphosphonates prevent age-related weight loss in Japanese postmenopausal women.

Decline of body weight with aging is a major risk factor for frailty, osteoporosis and fracture, suggesting that treatment for osteoporosis may affect body composition. Recently, we have shown that 5-year treatment with raloxifene prevented age-related weight loss, suggesting some other drugs for osteoporosis may also prevent a decrease in body weight with aging. The present study aimed to identify the relationship between bisphosphonate treatment and body composition markers. We measured bone mineral density (BMD), body composition, and bone remodeling markers in 551 Japanese postmenopausal women with bisphosphonate treatment, which included risedronate or alendronate treatment (BP-treatment group; N=193) and without treatment by any osteoporosis drug (no-treatment group; N=358) for 4-7years (mean observation periods; 5.5years) and analyzed the relationship of these with BMD, body mass index (BMI), body weight, and biochemical markers. The mean (SD) age of the participants was 68.6 (9.8)years in the BP-treatment group and 63.7 (10.6)years in the no-treatment group. Percent changes in body weight and BMI were significantly different between the BP-treatment and no-treatment groups (P<0.01 and P<0.01, respectively). In multiple linear regression analysis, bisphosphonate treatment was a significant independent determinant of percent changes in body weight and BMI (P<0.01 and P=0.01, respectively). Long-term use of bisphosphonates prevented reductions in BMI and body weight, usually observed in elderly women. Our results suggest that bisphosphonate treatment not only reduces the risk for incident osteoporotic fractures but also for frailty in the elderly.