Clinical Research Directory

Bariatric Surgery vs. Semaglutide vs. Tirzepatide

The recent introduction of the new generation of anti-obesity medications (AOMs) will change the future of obesity treatment. These highly effective medications, such as high-dose semaglutide and tirzepatide, are hormone analogues that augment the incretin function and exert multiple physiological effects by activating glucagon-like peptide-1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) distributed in various organs. These medications provide an average of 15-22% weight reduction in one-year trials, which had not been seen in the past with medical therapy. While the literature suggests that bariatric surgery is superior to these new highly effective medications, there is no head-to-head comparison between the most common bariatric operations (Roux-en-Y gastric bypass \[RYGB\] and sleeve gastrectomy \[SG\]) with semaglutide (once weekly) and tirzepatide (once weekly). The goal of this Randomized Clinical Trial (RCT) is to compare these effective therapies in patients with severe obesity to provide the best evidence to inform clinical decisions in treating patients with obesity.

UTSW NORC Pilot Spinal Cord Injury Dietary Program

The goal of this observational study is to learn about the effects of a 9-week dietician-guided program modified from the National Diabetic Prevention Program (modified DPP-diet) in people with spinal cord injury on body composition and insulin sensitivity. The main question it aims to answer is: Does 9 week modified DPP-diet reduce body fat percentage and insulin resistance? Participants will: Have 9 weeks of Telehealth visit with dietician certified in providing DPP. Visit the laboratory before, immediately and 9 weeks after completion of the modified DPP-diet. Share with the researcher on the perceived benefit and obstacles in implementing the modified DPP-diet as part of their daily activities.

A Wearable Device and AI-Supported Diet and Exercise Intervention

This study implemented a personalized 6-month diet and exercise program to promote weight loss. Participants were recruited from outpatient clinics at the Department of Family Medicine, National Taiwan University Hospital. Overweight and obese adults were eligible, defined as follows: overweight (BMI 24-27 kg/m²), mild obesity (BMI 27-30 kg/m²), moderate obesity (BMI 30-35 kg/m²), and severe obesity (BMI ≥ 35 kg/m²). Exclusion criteria included recent weight changes exceeding 3%, a history of bariatric surgery, untreated psychiatric disorders, or medications affecting body weight. Study design: Of the 171 subjects screened, 29 were excluded due to BMI criteria, leaving 142 participants for baseline body composition and biochemical analysis. Of these, 98 joined the 6-month weight loss program, while 44 remained in the control group. Participants were divided into two groups: one followed a standard diet and exercise program, while the other used a wearable device and AI apps alongside the same program. The wearable device tracked steps, heart rate, and estimated calories burned. Outpatient visits occurred at weeks 0, 12, and 24, with additional diet and exercise education. Phone consultations at weeks 2, 4, and 8 provided 10-minute guidance sessions from case managers. Weight loss medications were not permitted during the study. Data collection: Weight, height, and blood pressure were measured using standard scales and sphygmomanometers. Waist circumference was measured by a trained operator, and bioelectrical impedance analysis was used to assess skeletal muscle, fat mass, and body fat percentage. Blood samples were collected after an 8-hour fast to measure glucose, cholesterol, and triglycerides. Insulin levels were measured, and HOMA-IR was used to assess insulin resistance. Galectin-1 levels were measured using an ELISA kit. Measurements were taken at baseline and at the end of the intervention (week 24). Diet and exercise intervention: All participants followed a standard diet and exercise program. Those opting for the wearable device aimed for 7,500 steps per day, following World Health Organization recommendations for 150 minutes of moderate aerobic activity per week. Dietary education included caloric intake calculations and Mediterranean diet principles. Participants using wearable devices logged daily steps and food intake, which was uploaded to a health management platform. Case managers provided lifestyle coaching through the platform.

Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss

The objective of this study is to assess the long term weight loss and weight loss journey of patients who received an Endoscopic Sleeve Gastroplasty (ESG) 5 or more years prior to enrollment.

Advancing Biopsychosocial Care Training Initiative

This project will compare two training approaches for US Preventive Services Task Force recommended obesity care in Federally Qualified Health Centers (FQHC) across four aims. Aim 1 compares patient-level effectiveness \[i.e., patient relative weight change and the proportion of patients who achieve clinically significant weight loss\]. Aim 2 compares reach (patient treatment utilization). Aim 3 compares primary care provider (PCP) referrals to USPSTF-recommended care at 12 (adoption) and 24 months (maintenance) and short- and long-term changes in provider obesity care competencies . Aim 4 compares implementation and service costs.

Weight Changes After Incretin-mimetics

The goal of this study is to identify people at risk of weight regain after stopping an injectable weight loss drug. The main question the investigators aim to answer is: Can weight regain be predicted by measuring circulating Agouti-related peptide, a small protein coming from the brain?

"F!reF!ghterF!t": Lifestyle Coaching Interventions for Obese Firefighters (FireFit)

Our goal is to explore the effectiveness of 9- month lifestyle medicine based coaching intervention (individual and group coaching) versus control (usual care/ written health instructions). The primary study outcomes will be mean changes in body composition metrics . Secondary outcomes will be the prevalence of metabolic abnormities, progression/regression of Metabolic Syndrome, push-up \& sit/stand capacity, self-reported physical activity, and quality of life/diet/sleep measures.

A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes

This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.

New Mechanisms of Obesity

Given the pervasiveness of Pediatric Obesity, it is imperative to understand its pathophysiology and develop alternative strategies to reverse this condition. Herein, investigators propose to elucidate the interaction between colonic fermentation and insulin resistance in modulating metabolism in youth with obesity.

Glucose-dependent INsulinotropic Polypeptide: Effect on Bone Remodelling and Cell Activity (GINEBRA)

Glucose-dependent insulinotropic polypeptide (GIP) is released by the intestines in response to food intake and increases insulin secretion. Although short-term (\< 3 hours) stimulation with GIP decreases bone resorption in humans, the effect may vanish following continuous administration within 24 hours, at least in patients with type 1 diabetes. Whether the anti-resorptive effect of GIP can be maintained if the hormone is non-continuously administrated is unclear. As the first GIP receptor (GIPR) agonist, tirzepatide was recently approved for the treatment of obesity and type 2 diabetes in the USA and type 2 diabetes alone in the EU, there is a need to establish knowledge about the long-term effects of GIP on bone health, including if different exposure times to GIP have different skeletal effects. This project will investigate whether GIP maintains its anti-resorptive potential if given as intermittent compared to continuous infusion in healthy men and women aged 18-40 years. Administration cycles involve intermittent (8 hours daily) and continuous (24 hours daily) injection of GIP for three days each. The effect of GIP will be measured by bone markers in blood samples, as well as in vitro activity and genetic alterations of bone cells (osteoclasts and osteoblasts) using bone marrow aspirates and bone marrow biopsies. Each participant will receive both administration cycles using a crossover design with a 14-28 days washout period between administrations of GIP.

Metabolic Effects of Short-term Ultra-processed Food Intake (MEST-UPF)

The overall aim of this project is to study the effects of short-term high ultra-processed food intake, compared to nutrient- and energy density matched low ultra-processed food (UPF) intake, on energy intake and appetite. A total of 24 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. A randomized 2\*2 factorial four-way crossover study will be conducted at the Department of Internal medicine and Clinical Nutrition at the University of Gothenburg, comparing a high-UPF meal to a low-UPF meal also with high and/or low energy density. A supervised breakfast meal will be served, and postprandial blood samples and appetite measures will be collected continuously up to 4 hours after the breakfast meal. Subsequently, an ad libitum lunch meal will be served, and energy intake will be recorded.

Metabolic Surgery for Atrial Fibrillation Elimination

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. It is estimated that between 3 and 6 million Americans are currently living with AF, while 12 million people in the United States will have AF in 2030. Obesity and its comorbidities such as type 2 diabetes (T2DM), hypertension, and obstructive sleep apnea (OSA) are major risk factors for development and progression of AF. Metabolic and Bariatric Surgery (MBS) is the most effective currently available treatment for obesity. Patients typically lose 20 to 35 percent of body weight after surgery which is often sustained for many years. MBS can improve all 5 major risk factors of AF including obesity, hypertension, T2DM, OSA, and systemic inflammation. The purpose of the study is to understand if MBS can affect the severity of AF and the toll AF's symptoms take on patients.

Evaluation of Cognitive Improvement After Bariatric Surgery Using a Virtual Reality Program and the Neuropsi Neuropsychological Battery

Background: Obesity is a chronic, systemic, and multifactorial disease affecting populations worldwide, with projections indicating a 50% increase by 2035. It is linked to higher risks of cognitive decline, brain atrophy, and neurodegenerative diseases like Alzheimer's. Bariatric surgery has shown benefits in reducing fat and systemic inflammation, which may improve cognitive function. However, the factors predicting such improvements remain unclear. Objective: To evaluate the effect of bariatric surgery on cognitive performance using virtual reality (Neurotracker) and the Neuropsi neuropsychological battery. Methods: This prospective quasi-experimental study will include patients with morbid obesity who are candidates for bariatric surgery. Cognitive performance will be evaluated using the Neurotracker virtual reality tool and the Neuropsi neuropsychological battery. Participants will complete Neurotracker sessions three times weekly for two weeks before surgery, and again at 3- and 6-months post-surgery. The Neuropsi assessment will be conducted once prior to surgery and repeated at 6 months afterward. Statistical analyses will compare cognitive performance before and after the surgical intervention. Expected Outcomes: The study aims to identify measurable improvements in cognitive function after weight loss from bariatric surgery, evaluated through both traditional neuropsychological tests and immersive virtual reality tools. These results could improve understanding of the cognitive benefits of surgical obesity treatment and the factors that predict these outcomes.

Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)

The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases, nutrition, and metabolism (the process by which a substance is handled in the body) at the University of Missouri. As technology changes and uses new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure the results are accurate. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. This study will look at the validation and reproducibility of tests and laboratory assays in participants who are healthy or affected by relevant endocrine, cardiometabolic, and musculoskeletal disorders.

Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia

This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia.

Postoperative Gastroesophageal Reflux Symptoms After Laparoscopic Sleeve Gastrectomy Based on the Presence of Preoperative Symptoms

This study aims to investigate the patterns of reflux symptoms after laparoscopic sleeve gastrectomy based on the presence or absence of preoperative gastroesophageal reflux symptoms.

2024 Tirzepatide-Bariatric Surgery

This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity. The major objectives are: 1. To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery. 2. To establish the relationship of these changes with postoperative improvements in weight loss, metabolic and inflammatory profiles, comorbidity resolution (glycemic control, blood pressure, lipid profile), and 30-day surgical complications. Researchers will compare data from patients taking tirzepatide to data from patients not taking tirzepatide before their planned bariatric surgery to see if tirzepatide reduces inflammation and improves health outcomes after bariatric surgery. Participants will: Take or not take tirzepatide, depending on what study group they are in, once a week for 3 months. Visit the endocrine clinic once a month for 3 months to be prescribed the drug and for checkups regarding side effects due to the drug. Keep a diary to document taking the drug and any side effects. Continue with their planned bariatric surgery and post-surgery follow-ups according to their healthcare provider.

Outcomes Of Laparoscopic Sleeve Gastrectomy In Patients With Hypothyroidism And Depression

Sleeve gastrectomy (SG) continues to be one of the most popular bariatric procedures all over the world. It has been established that obesity is a predisposing factor for several comorbidities, including life-threatening conditions. Many studies have discussed the impact of sleeve gastrectomy on TSH level. But, since most obese patients have some sort of depression, we will try to study the impact of sleeve gastrectomy, depression and hypothyroidism on each other.

Precision Nutrition Technologies for Obesity Management

The implementation of this project will develop and apply precision health dietary solutions tailored for weight management in China's obese population, establishing a precision nutrition intervention model. Over 50% of the obese individuals are expected to achieve a weight reduction of more than 5%, significantly improving their quality of life.

Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease

A generic screening study to establish structural and/or functional baselines of specific organs.

Monitoring Nutritional Consequences of Obesity Treatment on Women's Health

The goal of this observational study is to investigate the long-term effect of obesity treatments on the health of women. This study will specifically focusses on the effects on nutritional intake, nutritional status, musculoskeletal health and reproductive health. Additionally, this study will also investigate the effect of obesity treatment on pregnancy outcomes and child development. To achieve the goal of this study, participants already receiving either surgical treatment for obesity or treatment with anti-obesity medication as part of their regular medical care will fill in additional questionnaires, provide blood, urine and feces samples, and undergo additional measurements of body composition and muscle strength up to for 10 years.

Empowering Healthy Lifestyle Personalised Intervention to Prevent and Control Obesity: The HealthyW8 Project

The goal of the HealthyW8 study (an intervention study) is: To assess the usefulness and effects of a digital-based healthy lifestyle recommender system (HRLS) on the prevention of obesity in the following propulations: schoolchildren (5-10 y) and their parents, young adults (18-25 y) and elders (\>65 y). The main questions it aims to answer are: Outcome 1: To select and validate a tool-assisted 3-mo intervention (mostly digital) by iteratively testing the HLRS on reducing risk of overweight/obesity among the described age groups. Outcome 2: To assess the effect of 1-y interventions (mostly digital) with the HLRS described and further iteratively improved previously (outcome 1) on reducing risk of overweight/obesity at described ages. Researchers will compare the intervention group before the intervention (baseline) and after it (3-mo intervention trial), or control group (standard care) vs. Intervention group (1-y intervention) to see changes on changes in overweight/obesity, and related parameters (body composition and biomarkers). Participants will follow the HLRS recommendations (meal plans, physical activity and sleep pattern measures and recommendations, assessment of behavioural/psychological aspects, and motivational features through digital devices), which will be assessed by means of measurement of body weight, body composition, and biomarkers.

Changes in Fat and Muscle Tissue Function and Their Impact on Metabolic Health After Bariatric Surgery

This prospective, single-center observational cohort study aims to explore the relationship between skeletal muscle quality, fat distribution, and metabolic health in Chinese patients with obesity, and to evaluate how bariatric surgery influences these parameters. A total of 120 participants will be enrolled, including 60 patients undergoing bariatric surgery and 60 age- and sex-matched healthy controls. The study involves cross-sectional comparisons of ectopic fat and muscle composition, as well as longitudinal follow-up of surgical patients at multiple time points up to 5 years postoperatively. MRI will be used to quantify regional fat and muscle composition, while metabolic parameters, inflammatory markers, and gut microbiota profiles will also be assessed. Primary outcomes include skeletal muscle mass and fat infiltration, visceral and subcutaneous fat volumes, and changes in insulin resistance. This study seeks to clarify the mechanisms by which bariatric surgery improves metabolic function and to identify early changes in muscle-fat composition that may predict long-term metabolic outcomes.

Study on the Weight Loss Effects and Mechanisms of Probiotic Preparation Intervention in Weight Cyclers

1. Study Background and Purpose Obesity is a complex chronic disease closely linked to comorbidities such as cardiovascular disease, hypertension, and diabetes. With lifestyle changes, obesity prevalence continues to rise. Current treatments focus on weight loss through dietary control and exercise, but weight regain is common due to metabolic adaptations (e.g., post-caloric restriction). Gut microbiota play a critical role in weight management, and probiotics may reduce weight regain by modulating appetite and metabolism. Studies suggest probiotics enhance satiety and reduce appetite. This study aims to evaluate the potential of probiotics in obesity management, specifically their impact on gut microbiota modulation and hormonal regulation to mitigate weight regain. Ethical approval has been obtained from the Peking Union Medical College Hospital Ethics Committee. 2. Study Design This 198-participant, randomized, interventional trial will assign subjects to three groups (1:1:1 ratio): Placebo group (maltodextrin-based placebo) Probiotic Group 1 Probiotic Group 2 Randomization will be conducted via sealed envelopes (no researcher/participant bias). All groups receive standardized nutritional counseling, caloric restriction plans, and body composition assessments. Probiotics (produced by Shenzhen BaoShiJian Biotechnology Co., Ltd., compliant with standard Q/BSJ 0023S-2024) will be administered orally (2 bottles twice daily) for 84 days . 3. Study Procedure Informed Consent : Required before participation. Screening Phase : Demographic history, medical records, concomitant medications, validated questionnaires, body composition analysis, and blood/urine/stool tests. Intervention : Daily probiotic or placebo intake for 84 days. Follow-ups : Visits at Day 42 and Day 85 for adherence checks, anthropometric measurements, and repeat testing. 4. Study Completion Duration : 84 days. Post-Study : Placebo group receives 1-month free probiotic supply; others return to standard care. A 30-day post-study follow-up (phone/WeChat) will assess safety. Withdrawal : Participants may exit anytime. Investigators may withdraw participants for safety reasons. 5. Potential Benefits Personalized nutrition counseling and body composition reports. Free clinical evaluations and health coaching. Contribution to novel weight management strategies for weight-cycling populations. 6. Risks and Discomforts Adverse Events : Gastrointestinal symptoms or discomfort. Immediate reporting required for medical management. Inconveniences : 3 on-site visits (blood/urine/stool tests, anthropometry) with fasting blood draws (\~7-20 mL/session). 1 telehealth visit (25 min questionnaire). Daily diary cards. Compensation : 150 RMB travel reimbursement + study-provided scales. 7. Alternative Options Participants may opt for: Intermittent fasting. Pharmacotherapy (e.g., GLP-1 agonists). Standard dietary recommendations. 8. New Information Any significant findings during the trial will be communicated to participants, who may choose to continue or withdraw. 9\. Costs and Reimbursement No-cost : All investigational products (probiotics/placebo), lab tests, and body composition analyses. Reimbursement : 150 RMB travel compensation + study tools (body fat scale, food scale, tape measure). 10\. Adverse Event Policy All injuries attributed to the intervention will be covered by Shenzhen BaoShiJian Biotechnology Co., Ltd. 's insurance. Legal liability extends beyond insurance coverage.