Clinical Research Directory

Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes

Compare use of the Magnet System in side-to-side duodeno-ileostomy (Surgery) with semaglutide (Medication).

CARTIZ Registry: Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts - A Four-Institute Mexican Observational Registry

CARTIZ is a prospective observational clinical registry of adults in Mexico receiving tirzepatide (a dual GLP-1/GIP receptor agonist) under an independent clinical indication - typically type 2 diabetes, insulin resistance, obesity, renal protection, metabolic hypertension, or associated off-label metabolic use. The registry is entirely observational: CARTIZ does not initiate, modify, interrupt, or supply tirzepatide, and does not dictate dose, route, or duration. All pharmacological exposure decisions are made by the treating physician independently of study participation. The registry is operationalized through a four-institute architecture integrating three Mexican National Institutes of Health and one national imaging laboratory. Core 1 (Knee Cartilage Imaging, Ci3M UAM-Iztapalapa) performs bilateral 3T MRI with quantitative T2 mapping at Week 0 and Week 52. Core 2 (Cardiac Imaging, Instituto Nacional de Cardiología Ignacio Chávez) performs non-contrast cardiac computed tomography for radiomic phenotyping of epicardial adipose tissue at Week 0 and Week 52 under cardiovascular Co-Principal Investigator Dr. Erick Alexánderson Rosas. Core 3 (HLA Typing, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Transplant Department) performs Class I and Class II HLA typing by PCR-SSO Reverse Luminex. Core 4 (Body Composition, Universidad La Salle México) performs multi-frequency bioelectrical impedance analysis (seca mBCA) at six longitudinal timepoints capturing visceral adipose tissue trajectory, phase-angle trajectory, appendicular skeletal muscle mass, and hydration ratios at zero marginal cost. The registry enrolls n=30 patients across three clinical sites with identical protocol (IMSS Clínica Río Magdalena, INCMNSZ outpatient clinic, and a private practice site in Mexico City), generating 60 evaluable knees and 30 paired cardiac CT studies. The primary co-endpoints address a mechanistic question no other tirzepatide study is positioned to answer: whether the articular response to tirzepatide in inflammatory arthropathy precedes and mechanistically precedes weight loss, through formal mediation analysis of Week-4 ACR20 response via high-sensitivity C-reactive protein, SERPINB2, and dipeptidyl peptidase-4 activity, restricted to the Mechanistic Analysis Set of patients with tirzepatide exposure ≤16 weeks at Week 0 and delta-BMI \<1.0 kg/m² through Week 4. A prespecified Surgical Tissue Subcohort is declared at initial registration to establish public scientific priority on direct human epicardial adipose tissue transcriptomic characterization under dual GIP/GLP-1 receptor agonism. Subcohort participants who undergo clinically indicated cardiac surgery at INCar during follow-up (coronary artery bypass grafting, valve replacement, or combined procedures) are invited to provide specific additional informed consent for collection of epicardial adipose tissue fragments routinely excised during operative access and otherwise discarded as surgical waste. Operational launch is contingent on separate INCar tissue-specific approvals and will proceed via PRS record amendment when ready

Effects of Bariatric Surgery on Cardiovascular Risk Profile in Relation to Inflammatory Parameters: Endothelial Phenotyping and Analysis of the Cross-talk Between Adipose Tissue and Endothelium

This research project aims to study how obesity affects the heart and metabolism, and how these effects change after significant weight loss following bariatric surgery. In particular, we want to look at how blood vessels and fat tissue function in people with obesity, to detect early signs of vascular problems and understand how fat tissue communicates with blood vessels. Our main idea is that obesity disrupts the normal function of blood vessels, partly due to substances released by fat tissue and changes in gut bacteria. We believe that 6 and 12 months after surgery - with proper weight loss - these problems will gradually improve. We expect to see better blood vessel function and lower levels of inflammation and fat-related substances in the blood, which could significantly reduce the overall risk of heart disease.

Continuous Glucose Monitoring in Metabolic Surgery

We will recruit 20 severely obese participants at Metamor Institute. Participants with obesity who are eligible for MBS will be randomized to either CGM group or self-monitoring of blood glucose (SMBG) group before the surgery based on a 1:1 ratio. All participants live in Baton Rouge, Louisiana. The surgeon in Metamor will introduce our study to the patients. If the patients are interested, the evaluation process includes verifying basic personal information, assessing health status and medical history, and evaluating specific eligibility criteria relevant to the study. The study coordinator will be discussing informed consent, ensuring participants understand the study's purpose, procedures, and any associated risks or benefits. Participants are encouraged to ask questions, ensuring clarity and comfort with the study. All collected data is documented and securely stored, respecting data privacy protocols. Eligible individuals are informed about the screening visit, while those not suitable are considered for future studies.

The ISAR InflEx Trial (Inflammation and Exercise)

A sedentary lifestyle and obesity are associated with chronic low-grade inflammation and an elevated risk of cardiovascular disease (CVD). This study aims to systematically characterize and compare the effects of three distinct exercise modalities - moderate-intensity, vigorous-intensity, and short-duration maximal exercise - each differing in duration and intensity, on systemic inflammation and immune function. The study investigates the potential of exercise as an effective anti-inflammatory intervention for the prevention of CVD.

Role of the Environment in Pediatric Obesity

Childhood obesity is a particular concern in developed countries such as the United States, the United Kingdom, Canada, and certain European countries. According to the World Health Organization (WHO), approximately 6% of children under the age of 5 worldwide were obese in 2016, a figure that continues to rise. The pathophysiology of pediatric obesity can be explained by several interconnected biological and behavioral mechanisms. In particular, it involves dysfunctions in the hormones that regulate appetite and satiety, as well as dysfunctions in lipid metabolism. Per- and polyfluoroalkyl substances (PFAS) are a large family of synthetic chemical compounds. The main PFAS are perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), and perfluorohexanesulfonic acid (PFHxS). PFAS are present in many everyday consumer products. Bisphenol A (BPA) is a chemical compound used primarily in the manufacture of plastics and resins. It is commonly found in polycarbonate plastics, used to make food containers and water bottles, as well as in epoxy resins, which are used to coat the inside of food cans and water pipes. Non-persistent pesticides, such as organophosphates and polychlorinated biphenyls, are chemicals used primarily in agriculture to control insects and other pests. There are arguments suggesting that PFAS, bisphenol A, and non-persistent pesticides may play a role in the onset of pediatric obesity, particularly by acting.

Effects of Gallotannins on the Gut Microbiome and How it Affects Inflammatory Markers Among Obese Individuals.

The goal of this clinical trial is to understand how gallotannin-rich (GT-rich) mangoes can reduce the inflammatory markers in obese individuals in vitro. The study will also seek to explore how gallotannins are metabolized in the gut microbiome. The main questions the research aims to answer are: * What is the impact of GT extract from mango and Lactiplantibacillus pentosus supplementation on inflammatory biomarkers in obese individuals? * Does the combination of GTs and L. pentosus exhibit synergistic effects in modulating specific microbial taxa associated with obesity and inflammation compared to either intervention alone? * Does genetic variation among individuals with obesity account for the ability to metabolize gallotannins? Researchers will compare the effects of GT extract from mango juice, a combination of GT-rich extract, and L. pentosus probiotic supplement on samples (stool) provided by obese individuals, to samples provided by a lean control group to see if gallotannins and gallotannins + probiotic supplementation reduce inflammation in obesity. Participants will * Be grouped into 4 treatment groups 1. Mango juice only 2. Mango + L. pentosus 3. L. pentosus only 4. Control (lean individuals) * Visit sample collection site one time during the study (week 1)

Positional Effects on Lung Ventilation and Perfusion in Obesity

Electrical Impedance Tomography (EIT) is a non-invasive, bedside monitoring tool that provides real-time information on regional ventilation and perfusion. In particular, EIT has the potential to guide individualized mechanical ventilation in obese patients by revealing how gravitational and positional factors alter regional lung behavior. Assessing the effects of different horizontal positions on both ventilation and perfusion may help optimize respiratory management strategies tailored to body habitus. By comparing obese and non-obese healthy participants across different positions, this study aims to provide novel insights into the postural effects on lung aeration and perfusion distribution, and to highlight the role of EIT in tailoring individualized ventilation strategies.

AI-INFORMED PEER-MENTORING BEHAVIORAL INTERVENTION FOR OBESITY AND CARDIOVASCULAR DISEASE PRIMARY PREVENTION IN YOUTH

The goal of this clinical trial is to learn if an AI-based peer-mentoring works to prevent obesity in adolescents and young adults. The main questions it aims to answer are: Does the AI-based peer-mentoring improve dietary habits and increase physical activity in healthy individuals 12-25 yrs old? Does the AI-based peer-mentoring reduces the risk of obesity? Researchers will compare the AI-based behavioral peer-mentoring intervention to traditional peer-mentoring and to health education intervention to see if AI-based peer-mentoring is more effective. Participants will: Follow either a structured AI-based peer-mentoring program or a traditional peer-mentoring program or health education sessions focusing on diet and physical activity They will be evaluated at baseline, at 6 months and at 12 months

Optimizing Self-Monitoring Feedback Delivery for the Treatment of Overweight and Obesity

The purpose of this research study is to learn how to best provide weekly feedback on individual progress toward intervention goals during a weight loss program.

Impact of a Pro-diversity Gut Microbiota Diet After a Bariatric Surgery on Gut Microbiota, Eating Behaviour and Sensory Function

Bariatric surgery is the most effective treatment for long-term weight loss and reducing obesity-related health risks. It alters the gastrointestinal tract as well as metabolic and hormonal functions, influencing eating behaviour. However, weight loss outcomes and long-term maintenance vary between patients, likely due to changes in the gut microbiota. Dietary recommendations aimed at improving microbiota diversity could help support sustained weight loss after surgery. The BariaGut Taste study aims to compare two dietary approaches following bariatric surgery: nutritional counselling promoting gut microbiota diversity versus standard nutritional counselling. One year after surgery, the study will evaluate differences in microbiota diversity, changes in food preferences and eating behaviours, sensory profiles (taste, smell), levels of digestive and gut hormones fasting, before and after eating, cardiometabolic parameters, mental health, physical activity, and more, to better understand Bariatric surgery is the most effective treatment for long-term weight loss and reducing obesity-related health risks. It alters the gastrointestinal tract as well as metabolic and hormonal functions, influencing eating behaviour. However, weight loss outcomes and long-term maintenance vary between patients, likely due to changes in the gut microbiota. Dietary recommendations aimed at improving microbiota diversity could help support sustained weight loss after surgery. The BariaGut Taste study aims to compare two dietary approaches following bariatric surgery: nutritional counselling promoting gut microbiota diversity versus standard nutritional counselling. One year after surgery, the study will evaluate differences in microbiota diversity, changes in food preferences and eating behaviours, sensory profiles (taste, smell), levels of digestive and gut hormones fasting, before and after eating, cardiometabolic parameters, mental health, physical activity, and more, to better understand the mechanisms that may explain variations in response to bariatric surgery. The BariaGut Taste study is a prospective, randomized, controlled trial with two parallel groups, involving non-diabetic patients aged 25 to 65 y undergoing either sleeve gastrectomy or Roux-en-Y gastric bypass. The trial will be conducted at the digestive surgery department of Edouard Herriot Hospital, the endocrinology-diabetes-nutrition department of Lyon Sud Hospital Center, and the Human Nutrition Research Center Rhône-Alpes. 60 participants are expected to be recruited, with 30 in each arm. Participants will be enrolled before surgery during a routine care visit with the surgeon. They will then undergo a metabolic assessment visit conducted exclusively for research purposes. This visit will allow to collect baseline data on primary outcomes via blood, expired air, and stool samples, anthropometric measurements, indirect calorimetry, a battery of questionnaires (TFEQ-21, DEBQ, PHQ-9, SF36, GSES, PANAS, ESUL, BES, DERS, GAD-7, IPAQ, BAQ, GSRS, sensory alterations, Bristol and Likert scales, and FNS), computerized food preference tests (LFPQ), and a standardized, video-recorded ad libitum buffet. Participants will be followed up at 3, 6, and 12 months after surgery through visits combining clinical care and research assessments. The dietary interventions specific to each group will be provided since the 3-month visit. The assessments conducted before surgery will be repeated at 6 and 12 months, also integrating clinical care objectives. Additional blood, stool, and adipose tissue samples collected during surgery will be stored to create a biobank.

Examining Valence-based Effects in Self-Monitoring Feedback Messages

The purpose of this research study is to learn how to identify the most effective ways to provide weekly feedback on participants' progress toward intervention goals during a weight loss program.

Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity

Tirzepatide is one of the new medications for the treatment of obesity. In clinical research people treated with Tirzepatide have weight loss up to 21%. But there is only a little bit of research showing the effect of Tirzepatide in clinical practice. In this retrospective observational study the investigators will evaluate the effectiveness of tirzepatide in routine clinical practice among adults with obesity in the Netherlands.The main questions it aims to answer are: * How much weight do patients lose after six months of treatment with tirzepatide combined with lifestyle coaching? * How is the medication dosed in daily practice? Researchers will use data from electronic health records of patients in multiple outpatient locations of the Dutch Obesity Clinic (NOK, Nederlandse Obesitas Kliniek).

A Prospective Cohort Study on Patient With Obesity Undergoing Weight Change

This prospective cohort study collected baseline data and followed up obese patients at their first visit to a weight loss clinic. The study examined the impact of various predictors and biomarkers on weight loss outcomes, aiming to establish an evidence-based foundation for personalized weight loss treatment. Participants underwent a battery of measurements and questionnaires, including height, weight, waist circumference, blood pressure, blood tests, and questionnaires addressing diet, exercise, stress, sleep, measure handgrip strength ,and psychological well-being.

Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

This study will explore whether tirzepatide is a practical and acceptable treatment for postmenopausal women with a history of hormone receptor-positive breast cancer and obesity. The investigators aim to understand whether participants are willing and able to take this medication once weekly for 6 months and whether it may help improve weight and overall health. There will be monthly check-ins to monitor progress and safety. At the beginning and end of the study, participants will undergo body composition assessments, blood tests and a stool sample will be collected, and surveys will be completed.

Predicting Difficult Intubation in Bariatric Surgery: Comparison of El Ganzouri Risk Index and Airway Ultrasound

This study is designed as a prospective observational study and will be conducted at the Health Sciences University Antalya Training and Research Hospital. Adult patients scheduled to undergo bariatric surgery will be included. The aim of this study is to compare the El Ganzouri Risk Index (EGRI) and airway ultrasonography (USG) parameters in predicting difficult intubation and to evaluate their relationship with the Cormack-Lehane (CL) score obtained during direct laryngoscopy. Before surgery, each participant will be evaluated using both the EGRI scoring system and airway USG. During general anesthesia, tracheal intubation will be performed using direct laryngoscopy, and data including the CL score, intubation time, number of attempts, and the need for videolaryngoscopy will be recorded based on the anesthesiologist's observations. The collected data will be analyzed by classifying participants according to the presence or absence of difficult intubation, and statistical comparisons will be performed between EGRI scores and airway ultrasonography parameters. The results of this study may contribute to improved preoperative airway assessment and enhanced patient safety in bariatric surgery.

Repeated Far Infrared Sauna Bathing in Adults With Obesity

This is a clinical trial to determine if 30 sessions of far infrared sauna bathing can improve cardiovascular and metabolic function in adults with obesity.

Real-World Registry Study of Integrated Traditional Chinese and Western Medicine for Obesity

Obesity is a major risk factor for cardiovascular disease, diabetes, cancer, and other chronic conditions. Due to its complex etiology and frequent comorbidities, effective obesity management requires comprehensive and individualized approaches. This study is a multicenter, prospective, real-world registry designed to evaluate integrated traditional Chinese medicine (TCM) and Western medicine interventions for obesity. The study will enroll at least 10,000 individuals with obesity from urban and rural populations. Multimodal data, including electronic medical records, laboratory test results, imaging data, and lifestyle information, will be collected. The effectiveness of integrated TCM and Western medicine interventions will be assessed across different age groups, disease stages, and obesity-related constitution types. In addition, disease progression patterns and key prevention and treatment points will be explored. Health economic analyses will be conducted to evaluate the cost-effectiveness of different obesity management strategies, providing real-world evidence to support public health policy and the optimization of integrated obesity prevention and management approaches.

Evaluation of Food Additive Contributions to Obesity: Pilot Study 1

The effects of food additives on body weight in humans are largely unknown. This is a pilot cross-over double blind RCT in obese adults aimed to test the feasibility of measuring food consumption over 24 hours after one-time administration of K sorbate versus placebo after participants reduce the background consumption of related food additives.

Real-world Canadian Retrospective Study Evaluating Longitudinal Semaglutide Use on Cardio-Kidney-Metabolic Outcomes

The goal of this study is to better understand the real-world effectiveness of semaglutide use on cardio-kidney-metabolic outcomes among adults with T2D and adults with obesity (without diabetes mellitus). This is a retrospective longitudinal analysis using the LMC Diabetes Registry. The primary outcome of the study is to evaluate the change in HbA1c between baseline to 3 years of follow-up among adults with T2D who initiated semaglutide compared to adults with T2D who initiated other AHAs, including sulfonylurea, dipeptidyl peptidase-4 inhibitors, and sodium-glucose cotransporter-2 inhibitors.

Dietary Insights and Nutrition Experiences in Adults on GLP-1 Therapy - A Study on Diet Quality Changes in Adults on GLP-1 Therapy

The DINE-GLP1 study aims to understand how people on GLP-1 therapy change their eating habits and what kind of dietary support they need. As more people use GLP-1 medications, there's not much guidance on what they should eat, mostly just focusing on managing symptoms and cutting calories. Since these medications reduce food intake, it's important to ensure the diet is nutritious even with fewer calories to help with long-term weight control and health. Most research has looked at how the body responds to the medication and whether patients take it as prescribed, but not much is known about what patients actually experience, what they think they need, or how they could use additional support. Understanding patients' views can help create better lasting solutions. Note that this study does not provide free GLP-1 medication.

Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: Recovery Effects After Semaglutide Termination

Semaglutide is a medication from the class of drugs called glucagon-like peptide-1 agonists that promote weight loss. There is little clinical data on the best strategy to achieve weight maintenance following weight reduction induced by semaglutide. For people who need to discontinue treatment, it is unknown whether the weight regain, its accompanied health benefits could be ameliorated with a gradual reduction in semaglutide. The investigators will study if a gradual reduction of semaglutide is associated with different heart risk profile and hormones involved in energy regulation as compared to immediate treatment cessation.

Tirzepatide and Muscle Outcomes in Obesity

This study is evaluating whether a dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, tirzepatide, can affect the function, structure and metabolism of skeletal muscles in adults with obesity. Participants, premenopausal females with obesity, will receive either tirzepatide or placebo over 24 weeks. Researchers will assess body weight, body composition, muscle strength and functional performance, neuromuscular function and will perform muscle biopsies before and after treatment to study molecular and histological changes following treatment. The goal of this study is to investigate the effects of tirzepatide on skeletal muscle function, quantity, quality and metabolism in adults with obesity as well as clarify the molecular and structural adaptations in skeletal muscle during tirzepatide-induced weight loss, addressing an important gap in understanding the impact of incretin-based therapies on muscle health.

Tirzepatide vs Liraglutide in Bone

This prospective cohort study investigates the effects of tirzepatide versus liraglutide on bone turnover markers and body composition in adults with class 3 obesity, characterised by Body Mass Index (BMI) ≥40 kg/m². Participants will be followed for 6 months with assessments at baseline, 3 and 6. The primary outcome is the change in bone resorption marker C-terminal telopeptide of type I collagen (CTX) at 3 months. Secondary outcomes include changes in body weight, BMI, bone mineral density (BMD), and body composition. The study aims to clarify the differential impact of weight loss achieved through tirzepatide versus liraglutide on bone metabolism and body composition in adults with obesity.