Clinical Research Directory

Time Restricted Eating for WeIght LoSs MainTenance-2

The TWIST 2.0 Study is a 12-month, 2-arm RCT in adults with recent weight loss. We will examine the efficacy of TRE on weight (Aim 1a) and fat mass (Aim 1b) regain, and describe changes in subjective appetite following a mixed-meal tolerance test (Exploratory).

Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment

This study will determine whether electrical stimulation of an area of the brain called the dorsolateral prefrontal cortex, which is important in determining the feeling of fullness after eating, affects how much food a person eats and weight loss over 4 weeks. It will also compare weight changes in people who attend weight loss counseling sessions and those who do not over this period of time. Obese, non-diabetic people between 18 and 60 years of age who are in good health and who live in the Phoenix, AZ, metropolitan area are eligible for this study. Candidates must have a body mass index of 35 kg/m(2) or more and weigh less than 350 pounds. Participants are admitted to the NIH inpatient unit in Phoenix for the first 9 days of the study for tests, which include meal tests to determine eating behaviors and caloric intake, blood and urine tests, glucose tolerance test, weight measurement, psychological assessments and DEXA scan to measure body fat. For 3 of the days, they will be asked to eat all of their food from automated vending machines. Some subjects receive transcranial direct current stimulation (TDCS). For this procedure, electrodes that conduct electricity are placed on the head and arm and the current is turned on for 40 minutes. Some tingling may be felt under the electrodes. Other subjects receive sham TDCS, with the current turned on only very briefly. After the evaluations, subjects are discharged home from the NIH unit and instructed to eat 25 percent fewer calories than they consumed while on a weight maintenance diet the first 3 days of their inpatient stay. They maintain the lower calorie diet at home for 4 weeks. During this period they come to the NIH unit 3 days a week to receive either real or sham TDCS.

Metabolic Health, Bones and Nuts During Weight Loss in Adults

The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain, and several dietary pattern studies indicate that nuts and legumes are associated with better bone health. In addition, our preliminary translational data indicates that a higher monounsaturated fatty acid (MUFA) intake is associated with improved bone mineral density (BMD) and quality. Given these findings, the proposed study aims to examine the impact of consuming peanut products on bone health, metabolic health (e.g., serum glucose, insulin, lipids and inflammation), markers of brain and sleep health, and physical function in overweight and obese older adults before and after a six-month weight loss intervention using a randomized controlled design. The results of this study have the potential to provide valuable insights into the role of peanuts as a sources of fatty acids in promoting health and preventing disease in at-risk adults.

Sustaining Health After an Intensive Weight-loss Pro-gramme

Since 2021 Copenhagen University Hospital - Hvidovre, Denmark, has offered a 2-year, highly specialised, intensive clinical weight loss programme to patients living with severe and complex obesity, who due to somatic and/or psychiatric comorbidity are not eligible for bariatric surgery. This understudied group often lacks treatment options despite significant functional impairment and high healthcare costs. The programme is based on an intensive dietary and behavioural support provided by trained dieti-cians. It begins with an 8-week period of full TDR of 800 kcal/day. During this initial phase the patients have bimonthly consultations with the dieticians, a schedule which continues throughout the first year. At week 6-8 the patients begin the treatment with GLP-1 receptor agonist (GLP-1-RA). Until medio 2024 patients without diabetes were treated with Liraglutide, thereafter Semaglutide has been used. After week 8 the patients transition back to a normal balanced diet, guided by the dieticians. Shorter periods of TDR can be used as a rescue-strategy in cases of weight-regain during the treat-ment period. In their second year of treatment the frequency of dietician consultations de-creases to once a month. Patients are scheduled to see a physician at the beginning of the treatment, at 4 months, at 12 months and at 21 months. At the end of the programme dieticians and physicians' advice on weight loss maintenance strategies including possibilities for cessation/reducing dose of weight loss medication but there are no clinical follow up visits. Overall research question What is the durability and long-term health effects of a hospital-based IWL-treatment programme, with specific attention to cardiometabolic health, body-composition and health-related quality of life, at least 1 year after cessation of treatment in a clinical cohort of patients living with severe obesity and multimorbidity? Study design This study is a post-intervention observational follow-up (FU) study, evaluating the durability of the IWL-treatment offered to patients at Hvidovre Hospital since 2022. This study is a substudy under the study-compilation SHAPe, consisting of a quality-assurance project evaluating the treatment programme, this post-intervention observational FU-study, a qualitative study exploring psychosocial and socio-economic precarity mediate adherence to the programme and durability of health outcomes and a societal and economic impact study to evaluate the impact on total health care costs and labour market attachment. The FU-visit will consist of a single investigation day at Hvidovre Hospital and will be scheduled at least 12 months after completing the treatment programme. Participants will provide blood and urine samples, undergo anthropometric measurements (weight, height, waist circumference), blood pressure assessment, and body composition analysis. They will also complete the SF-36 questionnaire and a . Additionally, they will be asked for consent to link their data to national registries for a 10-year follow-up on hospital admissions, medication use, and employment status. Biological samples may be stored for future analysis of metabolic biomarkers related to weight regulation. Due to the clinical nature of the study, it is exploratory and descriptive and hence does not include hypothesis testing, but instead an overall research question. Thus, it is designed with a non-hierarchical outcome structure, though with certain patient-centred "key outcomes." These outcomes have been chosen to reflect what is important for patients lives with skeletal muscle mass, health-related quality of life and weight as key outcomes. Additionally, we will explore the following outcomes: fat-mass, waist circumference, use of weight-loss medication, lower body strength, blood-pressure, HbA1c, lipid levels and potential proteomic biomarkes associated with regain vs weight maintenance. We aim to include 200 participants in the FU study.

Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC

The purpose of this trial is to learn whether participants who take rilogrotug gain weight, have a better appetite, and have a better quality of life than participants who do not take rilogrotug (placebo arm). Adult participants with cachexia who have also been diagnosed with metastatic colorectal or non-small cell lung cancer will be enrolled. The primary hypothesis is that after 12 weeks, rilogrotug will cause an increase from baseline in body weight and appetite (as measured by the Functional Assessment of Anorexia/Cachexia Therapy 5-item Anorexia Symptom Scale \[FAACT-5IASS\] questionnaire) compared to placebo.

Bimbingamba Zerosix Third Phase: Studying Communities

Childhood obesity is increasing in the last years especially in developed countries, and, as well as adult obesity, is related to the development of pathologies. Unfortunately, the restoration of a normal weight condition, if the ponderal excess rose in the first years of life, seems very difficult. Despite the importance of this issue, there is a paucity of evidence demonstrating effective interventions in reducing weight over time. The observation that in developed countries childhood obesity appears with evident social and geographical gradients justifies the implementation of inter-sectoral interventions of primary prevention, to be declined at the contextual level: family and community. Nowadays, there are numerous interventions for the promotion of lifestyle in pediatric age, in particular, those aimed at primary school and adolescence. On the other hand, few interventions were directed at the 0-7 age group. Therefore, this community intervention trial involved the pediatric population (aged 0-7 years) and their families, and it is aimed at the prevention of obesity and the restoring normal weight through community interventions aimed at improving lifestyles and with them the bio-metric parameters, health and well-being outcomes and soft skills in the population aged 0-7 years. The target population is children aged 0-7 years resident in the two municipalities (Mondovì and Savigliano), respectively selected as Intervention and Control Common. Totally, to conduct this study 2000 children, of both sex, will be enrolled (near 1000 for each of the two Municipalities).

OverStitch NXT Endoscopic Suture System

To demonstrate the safety and efficacy of OverStitch NXT Endoscopic Suture System for endoscopic sleeve gastroplasty（ESG） in obese populations to support the registration of OverStitch NXT for ESG indication.

Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')

To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365.

The Sleep2BWell Trial

Improving multiple domains of cardiometabolic health (CMH) through contextual behavioral interventions has the potential to substantially reduce persistent chronic disease disparities. Sleep is critical for preserving CMH and is amenable to intervention in real-world settings. Although sleep health, in conjunction with other lifestyle behaviors, can improve CMH through complementary or synergistic pathways, most existing lifestyle change programs focus solely on diet and physical activity. Sleep2BWell is a community-based cluster randomized trial aimed at evaluating the impact of incorporating a multidimensional sleep health intervention into the BWell4Life program, an ongoing 4-week program for promoting CMH through healthy diet and physical activity, delivered by peer health educators at faith-based organizations and community centers in underserved NYC neighborhoods. The enhanced 6-week intervention, Sleep2BWell, will include the following additional components: 1) two sleep health education and group coaching sessions, 2) self-monitoring and motivational enhancement using a Fitbit, and 3) addressing prevalent environmental barriers to healthy sleep in urban settings such as noise and light with a novel and timely extension to address indoor air pollution. A total of 10 community sites will receive the intervention enrolling an average of 15 participants per site for an expected sample of 150. The investigators will collect objective measures of sleep and physical activity throughout the study, and assess diet and CMH outcomes at baseline and 10 weeks (primary endpoint). The investigators hypothesize that Sleep2BWell will improve CMH, including reduced blood pressure (primary outcome) improved health behaviors (sleep, diet, physical activity) and adiposity markers (secondary outcomes). To ensure the successful completion and future expansion of this work, this study will use mixed methods to understand implementation determinants and outcomes, guided by implementation science frameworks. This first-of-its-kind effectiveness-implementation study, addressing individual level behaviors and factors and upstream influences and leveraging key behavior change and community engagement strategies, will investigate the integration of sleep health into a multi-behavior lifestyle change intervention aimed at addressing CMH disparities in community settings. This innovative multilevel intervention will inform scalable sustainable community health approaches and public health policy to improve sleep health and CMH disparities through advancement in novel multilevel bundled behavioral interventions.

Predicting Weight Gain and Weight Loss Associated With Overeating or Fasting

This study will investigate how to better predict why some individuals gain or lose weight more easily than others. It will examine whether the increase in the amount of energy a body burns in 24 hours with overeating or the decrease over 24 hours with fasting can help determine how easily someone gains or loses weight. Healthy people between 18 and 60 years of age who have a body mass index (BMI) between 18.5 kg/m(2) and 24 kg/m(2) (for overfeeding study) or a BMI greater than 27 kg/m(2) with a body weight less than 350 pounds (weight loss study) may be eligible for this study. The study requires a 10-week admission to the NIH Clinical Center (2-week baseline, 6-week overfeeding/weight loss, 2-week post-weight change). Participants undergo the following tests and procedures during the hospital admission: * Medical history, physical examination and laboratory studies * Questionnaires to assess eating behavior, food preferences, body composition, and activity level * Body composition assessment (height, weight, waist circumference, and fat mass and muscle content through DXA and MRI scans) * Oral glucose tolerance test * Meal test to measure the response of certain hormones to food * Activity monitors to determine activity level * Metabolic chamber study to measure calories burned over 24 hours and monitor body temperature * Free-living energy use study to measure calories burned under normal home conditions over 7 days * Fat and muscle biopsies * Dietary intervention: Measurements of food intake and energy loss over a 6-week overfeeding (1.5 times the subject s normal food intake) or weight loss (one-half the subject s normal food intake) program Followup procedures after the inpatient stay: * Height and weight measurements at 6 months (overfeeding study participants) and monthly for the first year, at 3-month intervals for the second year, and then yearly for 3 more years (weight loss study participants) * Yearly visits (2-night inpatient stay) for all participants for repeat meal test, DXA, oral glucose tolerance test, behavioral questionnaires and, in women who can become pregnant, pregnancy test

Teen Weight Control

The prevalence of obesity in adolescents is remarkably high, with 38.7% of youth 12-15 years of age and 41.5% of 16-19 year olds meeting criteria for overweight or obesity. Behavioral weight control interventions for adolescents have had limited impact on this field and there is considerably more that needs to be done. Notably, adolescents who have difficulty managing their feelings have been found to consume higher caloric foods and report greater amounts of sedentary time. Poor emotion management among adolescents has also been associated with more rapid weight gain and higher BMI. Data from adolescents with overweight/obesity attending our outpatient weight management program (N=124) indicate that 82% of these youth report emotion regulation scores that are comparable to youth with significant mental health problems. Despite documented relationships between adolescent weight control and emotion regulation, no proven adolescent weight management programs targeting emotion regulation exist. To fill this gap, our laboratory developed and piloted an adolescent weight control intervention (HealthTRAC) that combines two previously tested effective interventions, one targeting emotion regulation skill building, the other focused on behavioral weight control. Findings from our small pilot trial are promising and indicate that the newly created HealthTRAC intervention is acceptable to parents and teens, easy to deliver, and leads to modest weight loss and improved emotion management skills compared to a standard behavioral weight control (SBWC) program. These data suggest that emotion regulation is related to weight management and may assist adolescents with overweight/obesity who are seeking to lose weight. The current multi-site study builds on this previous work and will examine the impact of the developed HealthTRAC intervention on improving emotion regulation skills and reducing adolescent BMI in a larger sample with longer term follow-up (18 months after starting the intervention). Adolescents will receive 27.5 hours of intervention time over a 12- month period. We expect that adolescents enrolled in the HealthTRAC intervention will show greater reduction in BMI over the 12-month program and will sustain these losses up to 18 months after starting the intervention compared to teens enrolled in SBWC. The information learned from this project will help us better understand how helping adolescents manage their emotions can improve weight loss outcomes.

Aleniglipron Phase 2 in Type 2 Diabetes Mellitus

The purpose of this study is to assess the safety and tolerability of aleniglipron at doses up to 180 mg once daily (QD) in participants with T2DM who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2).

Diabetes Prevention Through Genetics, Familial History and Behavior Change

The goal of this clinical trial is to learn if adding a family engagement component to the standard Diabetes Prevention Program (DPP) improves outcomes for adults with prediabetes. It will also learn about the effects of this approach on family members' health. The main questions it aims to answer are: * Does adding family health history collection and family participation to the DPP improve session attendance compared to standard DPP? * Does this family-centered approach lead to greater weight loss and HbA1c (blood sugar) reduction compared to standard DPP? * Do health improvements extend to participants' family members, and what factors explain differences in family-level outcomes? Researchers will compare an adapted DPP with a family component to the standard DPP (individual-focused) to see if involving family members improves diabetes prevention outcomes. Participants will: * Be assigned to one of two groups: adapted DPP with family sessions, or standard DPP * If assigned to the adapted DPP, complete a family health history using the Center for Disease Control and Prevention's (CDC) My Family Health Portrait tool and attend 6 additional sessions with family members focused on personalized risk communication * Attend regular checkups to measure weight and HbA1c at 6 and 12 months * Have session attendance tracked throughout the program * Family members of participants may also be asked to complete health assessments to measure any changes in their own health behaviors

Small Intestinal Bacterial Overgrowth (SIBO) in Pancreatic Adenocarcinoma (PDAC)

The purpose of this study is to prospectively analyze the prevalence of SIBO in patients with Pancreatic adenocarcinoma (PDAC) and understand its association with weight loss and pancreatic resection status. Each patient will be tested for SIBO using Lactulose Hydrogen Breath Test. 100 patients with diagnosed pancreatic adenocarcinoma and clinically diagnosed weight loss will be enrolled in this study.

15-years Outcomes of Sleeve Gastrectomy on Weight Loss

Evaluate the beneficial and harmful effects of sleeve gastrectomy at 15 years in a pioneering center for this surgical technique in France

Weight Loss and Comorbidity Outcomes After Revisional Bariatric Surgery

Some people who have had weight-loss (bariatric) surgery do not lose enough weight, regain much of the weight they lost, see obesity-related diseases such as diabetes or high blood pressure return, or develop complications of the first operation. Many of them need a second, revisional operation. This study reviews the medical records of adults who had revisional bariatric surgery between 2017 and 2025 at a single surgical centre. It describes which revisional operations were performed after each type of first operation and measures how much weight patients lost 6 months, 12 months and up to 3 years after the revision. It also records whether obesity-related diseases and quality of life improved after the revision, and looks at patient factors linked to better weight loss.

Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia

This pilot clinical trial studies the side effects and best dose of metformin hydrochloride and ritonavir in treating patients with multiple myeloma or chronic lymphocytic leukemia that has returned after a period of improvement or has not responded to treatment. Metformin hydrochloride and ritonavir may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Oral VK2735 for Weight Management Phase 3 (SUNRISE 1)

This study is one of two planned Phase 3 studies to support the weight management indication for VK2735 Oral in obese (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27kg/m2) adults with at least one weight-related comorbidity without type 2 diabetes mellitus.

Reducing Weight and Diabetes Risk in an Underserved Population (STRIDE)

The purpose of this study is to examine the effectiveness of a lifestyle intervention designed to reduce weight and diabetes risk in a population of individuals with mental illness who are also taking antipsychotic medications. We will examine the effectiveness of the intervention in 1. reducing weight and Body Mass Index; 2. reducing fasting insulin levels and increasing insulin sensitivity; and 3. reducing total cholesterol and LDL cholesterol.

Effect of Dehydration on Sleep Quality, Cognitive Skills, and Electromyographic Responses in Combat Athletes

This study examines the effects of rapid dehydration-induced weight loss on combat athletes' sleep quality, cognitive skills, and isokinetic strength performance. The research documents both benefits and risks of weight-cutting practices for athletes, coaches, and medical staff in weight-class sports. Findings will guide safer weight management approaches and inform potential revisions to international weigh-in protocols, while contributing valuable insights to sports science.

Oral VK2735 for Weight Management in Adults With Type 2 Diabetes Mellitus Phase 3 (SUNRISE 2)

This study is one of two planned Phase 3 studies to support the weight management indication for VK2735 Oral in obese (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) adults with Type 2 Diabetes Mellitus.

Project Activate: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss

Mindfulness and Acceptance based Behavioral Therapies (MABTs) are among the most promising behavioral approaches for obesity, with two recent large trials showing that they achieve better initial weight loss and/or better weight loss maintenance than does gold standard behavioral weight loss treatment (BT). However, results vary, potentially due to inconsistencies in how MABT components are utilized and emphasized. Optimizing MABTs using a typical approach, i.e., successive randomized controlled trials of various MABT packages, is slow and difficult. Multiphase Optimization Strategy (MOST) has been developed as a better method of optimizing treatment. Consistent with Phase I of MOST, we derived three MABT components from the theoretical literature. Evaluation of MABT components through a factorial design (MOST Phase II) will allow us to determine the independent and interacting efficacies of each MABT component, in addition to the identification of subsets of individuals most or least responsive to each component. Whereas mediational analyses have been inconclusive, the use of a factorial design will allow for a critical test of the main and interaction effects of individual MABT treatment components. The current study will use a full factorial design to identify the independent and combined effects of three core MABT components (Awareness, Acceptance, and Values Clarity) as additions to remotely delivered weight loss counseling. Moderators of treatment outcome (disinhibited eating, food cue susceptibility, emotional eating, delay discounting, and inhibitory control), and mediator/process variables implicated in MABTs (mindful eating, acceptance of food cues, mindfulness, body responsiveness, autonomous motivation, values clarity, hunger/satiety perceptions, and motivation and pleasure resulting from social functioning) will be assessed as well.

Dyad Plus Effectiveness/Feasibility

The purpose of this research is to determine the effectiveness of a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. Participants of the Brenner FIT (Families In Training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the components of By Design Essentials.

Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass

The goal of this clinical trial is to evaluate weight loss with TORe and moderate to intensive lifestyle modification versus moderate to intensive lifestyle modification alone in subjects who have regained weight following a Roux-en-Y gastric bypass. Participants will randomized 2:1. Those randomized to the TORe arm will receive a TORe procedure and moderate to intensive lifestyle modification which consists of a well-balanced calorie restrictive diet, incorporation of exercise and coaching on lifestyle discussion. Participants randomized the lifestyle modification alone arm will be eligible to receive a TORe procedure at 6 months post enrollment. Total follow up will be 24 months.