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Morbid Obesity clinical trials

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NCT ID: NCT06293703 Recruiting - Morbid Obesity Clinical Trials

Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)

CLIMB II
Start date: January 12, 2024
Phase: N/A
Study type: Interventional

The investigators propose a randomized controlled trial comparing BP and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length versus current standard practice using fixed lengths. The findings would provide further insight into feasibility of standardizing RYGB limb lengths and optimizing resultant weight loss and metabolic effects. The investigators hypothesize RYGB with ratio-adjusted limb lengths (aRYGB) will result in higher total weight loss and resolution of metabolic syndrome comorbidities, including diabetes, hyperlipidemia, and hypertension compared to standard fixed-length RYGB (sRYGB). The study will also utilize the Short Form Rand 36-Item Health Survey (SF36) to determine differences in postoperative quality of life metrics.

NCT ID: NCT06268990 Recruiting - Diabetes Clinical Trials

FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT

DACH
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

This double-blinded proof-of-concept study is proposed to explore the effects of fecal microbiota transfer (FMT) in human subjects. Here we perform FMTs into obese recipients using stool from lean unoperated donors and from previously obese patients after successfull treatment with bariatric Roux-en-Y Gastric Bypass (RYGB) surgery. Obese patients treated with their own material (autologous FMT) serve as controls. After FMT treatment the functional impact of post-surgery microbiome changes on host energy consumption and regulation of blood glucose levels will be analysed. Additionally the variations on the microbiota and metabolite composition will be profiled using extensive sequencing analyses. The major aim of the study is to explore the scientific rationale for targeted gut microbiota modulation in management of obesity and related metabolic diseases.We estimate the transfer of microbiota from RYGB donors is superior to the transfer of lean microbiota at inducing reduced adiposity and improving high blood glucose levels in obese recipients. Each is better than a sham procedure (autologous FMT), which itself can also induce considerable short-term effects.

NCT ID: NCT06199635 Recruiting - Morbid Obesity Clinical Trials

Early Feasibility for Safety & Device Functionality of SFM Anastomosis Device Used in 3 Procedures (SNAP-S) or (SNAP-PS) or (J-J)

GIW-SFM
Start date: December 15, 2023
Phase: N/A
Study type: Interventional

The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a duodenal-ileal (D-I) anastomosis either during sleeve gastrectomy (i.e., SNAP-S procedure) or patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure) or a Roux-en-Y gastric bypass jejuno-jejunostomy. Additionally, the study is designed to evaluate the potential of these procedures to induce weight loss and to improve metabolic comorbidities in obese subjects.

NCT ID: NCT06132477 Recruiting - Hypertension Clinical Trials

Impact GLP-1 Agonists Following Bariatric

Start date: February 1, 2024
Phase: Phase 4
Study type: Interventional

Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person. GLP-1 receptor agonists (GLP1-RAs) have been shown to be effective in achieving weight loss in patients with type 2 diabetes while improving blood glucose control. Bariatric surgical procedures have been shown to be effective in treating obesity as well as superior to best medical therapy for treatment of diabetes not just through restriction of calories but also through a positive impact in modifications of gut hormones, changes in circulating bile acids, modifications in the gut microflora as well as other undefined mechanisms. The combined benefits of GLP1-RAs with bariatric surgery have only been studied to a limited effect. In this randomized trial, the effects of continuation or discontinuation of GLP1-RA therapy in patients undergoing bariatric surgery will be determined. We will compare changes in weight, metabolic determinants including circulating bile acids and gut microbiome, psychological determinants of eating behavior, and adverse side effects in patients who continue vs discontinue therapy. Given differences in metabolic and clinical outcomes in patients undergoing vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB), both surgical groups will be examined. The study will be conducted at a high volume bariatric surgical program where patients will undergo randomization at the time of final clinic visit prior to surgery to continue or discontinue GLP1-RA. It is hypothesized that participants who continue GLP1-RA therapy after bariatric surgery will lose more weight with improved blood glucose control than those who discontinue therapy. Furthermore, changes in gut microbiome and circulating bile acids, known determinants of metabolic health, will be modified to a differential extent in those who are on GLP1-RAs vs those where GLP1-RAs are discontinued. Understanding the role these medications play in not only clinical outcomes after metabolic surgery but potential metabolic mechanisms by which surgery improves patient's metabolic health could help people with obesity and type 2 diabetes make informed decisions about their treatment options as well as advise providers on the continuation of these medications in the perioperative and postoperative period.

NCT ID: NCT06102538 Recruiting - Morbid Obesity Clinical Trials

"Hachi Barie" Project - A Multidisciplinary Program to Accompany Severely Obese Teenagers in the Weight Loss Process for the Benefit of Their Recruitment Into the Israel Defense Forces

Start date: October 9, 2023
Phase: N/A
Study type: Interventional

Teenagers with body mass values (BMI) above 35 kg/m2 and co-morbidity are designated for medical disqualification from service in the IDF. Data show that there has been an increase in the incidence of these teenagers, specifically among the lower socioeconomic status. The purpose of this pilot study is to carry out an intervention Based lifestyle modification among a group of boys and girls with morbid obesity accompanied by a comorbidity that disqualifies them from service in the IDF. Definition of success: meeting the threshold of weight and health status that allows recruitment into the IDF. Criteria for finding candidates: - Boys and girls from the age of 15 who suffer from morbid obesity and comorbidity that may prevent their enlistment in the IDF. (This age range was chosen to allow an ideal period of at least one year to make a significant change). - Boys and girls who have their own and their family's willingness and commitment to participate in the process - A basic state of health that allows participation in the program. The screening process will be done by the staff of the endocrine unit, under the management of Prof. Orit Pinhas-Hamiel. Duration of intervention: 26 weekly sessions for the trainees. The duration of the meeting will be about three hours in the afternoon A decision whether to extend the duration of the intervention will be taken according to the initial results of the program. Activity location: Potential sites vary: Sheba// academic complex // military base for trainees. Number of participants - 25, (dropout expected 30%) Research goals (main content elements in the program) - there are 3 main content areas (of similar importance) - Education about the importance of service in the IDF and the opportunities inherent in it - Ability-adapted physical activity education and training - Guidance for a healthy diet - Psychological support [The medical accompaniment to the program will take place on the basis of the patients' mother clinics and the medical follow-up of them will be done separately].

NCT ID: NCT06015620 Recruiting - Hypertension Clinical Trials

Comorbidities Resolution After MGB Surgery and Change in Body Composition

MOGAMBO
Start date: September 1, 2023
Phase:
Study type: Observational

This observational study aims to learn about the correlation between the improving comorbidities associated with obesity after MGB (Mini-Gastric Bypass) surgery and changes in body composition in morbidly obese patients. The main questions it aims to answer are: To study the correlation between the improving comorbidities associated with obesity after MGB(Mini-Gastric Bypass) surgery and changes in body composition. Other objectives are: - Changes in the parameters of the metabolic syndrome after surgery - Changes in the cardiovascular risk biomarkers after metabolic surgery - Emergence in complications arising out of surgery requiring any intervention or causing a prolonged hospital stay, or requiring additional outpatient visits. Type of Study: An observational study in which participants with morbid obesity will undergo mini-gastric bypass surgery as per routine protocol. No separate experimental interventions will be done in the study for the participants.

NCT ID: NCT05930678 Recruiting - Morbid Obesity Clinical Trials

Intubation of Obese Patients in the Operating Room With or Without Bag-Mask Ventilation

VENT OR NOT
Start date: September 12, 2023
Phase: N/A
Study type: Interventional

The aim of the study is to answer a daily question in the operating room: what is the safest technique for intubation of severe/morbid obese patients (BMI 35 or more). There is a great heterogeneity of practices on the subject, so the principle is to determine a common practice to facilitate the management of these patients.

NCT ID: NCT05930184 Recruiting - Opioid Use Clinical Trials

Laparoscopic Guided Peri-wound Transversus Abdominis Plane Block With Bupivacaine Versus Local Wound Infiltration on Post-op Opioid Use in Laparoscopic Sleeve Gastrectomy

Start date: April 29, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this randomized controlled trial is to compare laparoscopic guided peri-wound Transversus Abdominis Plane Block and bupivacaine versus local wound infiltration effect on reducing post-op opioid use in Laparoscopic Sleeve gastrectomy. The main questions it aims to answer are: • Can laparoscopic guided peri-wound Transversus Abdominis Plane Block reduced post operative morphine usage when comparing with local wound port site infiltration. Participants will be randomize into 2 group - peri-wound Transversus Abdominis Plane Block - local wound port site infiltration

NCT ID: NCT05856617 Recruiting - Morbid Obesity Clinical Trials

Remimazolam vs Propofol as an Induction Agent for Morbid Obesity Patients

Start date: October 25, 2022
Phase: Phase 4
Study type: Interventional

It is known that morbidly obese patients are often accompanied by cardiovascular complications such as hypertension, cardiac hypertrophy, and diastolic dysfunction, and are known to increase the risk of hypotension during anesthesia induction. Remimazolam is widely used in Japan and the United States, and it was approved as a drug for general anesthesia and sedation in Korea in 2021. It was reported that remimazolam caused less hypotension after induction of anesthesia than propofol. However, there is no study on the use of remimazolam in patients undergoing bariatric surgery due to morbid obesity. Therefore, through this study, we plan to check whether remimazolam is safe and effective as an anesthetic-inducing agent for morbidly obese patients undergoing bariatric surgery.

NCT ID: NCT05783466 Recruiting - Morbid Obesity Clinical Trials

Dairy Lipids and Cardiometabolic Risk

DAILICATE
Start date: June 28, 2023
Phase: N/A
Study type: Interventional

It is a randomized parallel arm intervention study in adults with severe obesity. The objective is to demonstrate that within a dietary handling for weight loss, the daily ingestion during 3 months of whole dairy products enriched with milk polar lipids or whole dairy products decreases to a greater extent fasting plasma apolipoprotein B concentrations than the daily ingestion of low-fat dairy products (control group). Metabolic parameters will be assessed before and after the 3-month intervention, both at fasting and in postprandial period after the consumption of standardized meals.