Loading clinical trials...
Loading clinical trials...
Showing 1-10 of 10 trials
NCT07280845
The main questions to answer are: * Weight outcomes in weight strata over time? * What was the proportion of patients reaching sufficient weight outcome in different weight strata? * To what extent are co-morbid conditions improved or put in remission? * What is the risk of experience a complication? * What was the proportion of patients converted to another bariatric procedure? * What us the reason for conversion? Participants already undergone bariatric surgery as part of their regular medical care for severe obesity and only registry data will be analyzed.
NCT02767505
This is nationwide registry-based randomised clinical multicenter trial in which patients will be randomised to gastric bypass (RYGB) or sleeve gastrectomy (SG). The co-primary endpoint are weight control over 5 years and the amount of severe adverse events. Additionally the investigators have predefined a number of secondary endpoints, and the trial has a sufficient number of patients to allow comparisons across subgroups.
NCT03538210
Obesity prevalence rapidly increased in the past decades in French population with multiple health consequences responsible for excess mortality. In the same period of time, the number of bariatric procedures have developed exponentially. Despite its great efficacy on weight loss but also on resolution of comorbidities, bariatric surgery is not without risks. Our hypothesis is that a better understanding of the physio-pathological consequences of obesity and bariatric surgery, notably on the gastrointestinal tract, may allow to improve the treatment of obesity and to find alternatives to bariatric surgery. The main objective of this cohort study is to systematize the collection and the conservation of biological samples (blood, stomach, liver, intestine, adipose tissue) obtained during bariatric surgery, in obese subjects undergoing surgery (including sleeve gastrectomy, Roux-en-Y gastric bypass, or revisional intervention for complication or weight regain) in the University Hospital group of Paris Nord Val de Seine (HYPNVS). The main projects that will build on this cohort will cover the physiopathology of obesity and its consequences, notably in the field of gastrointestinal tract including: modification of gastro-intestinal plasticity in severe obesity and after bariatric surgery and alterations of absorption of nutriments (lipids, proteins, carbohydrates) induced by obesity and bariatric surgery. The inclusion in this project of obese subjects before surgery, or lean or obese subjects after surgery will allow to distinguish the impact of weight loss and surgery on gastrointestinal remodeling. This cohort will also allow to characterize stomach and intestinal proteome in severe obesity and to precise the influence of tissue inflammation on metabolic disorders associated with obesity.
NCT05493592
Adult obesity is due to an excess of body fat. This corresponds to all the fat in the body (or adipose tissue). It is opposed to the lean mass which corresponds to the weight of muscles, organs and viscera. It is defined from the body mass index (or BMI). BMI is calculated by dividing a person's weight by their height squared. According to these criteria, the prevalence of obesity has reached 17% of the entire adult population in mainland France (ESTENBAN 2015 study). The prevalence figures for obesity in the French overseas departments are higher than in mainland France. The latest epidemiological data available in Martinique and Guadeloupe (KANNARI 2015 study) show that approximately 60% of the adult population is overweight and 25% of the adult population is obese. Obesity is considered a chronic disease that increases the risk of cardiovascular and metabolic complications all the more when patients have a BMI ≥ 35 kg/m2, defining severe obesity. When BMI is equal to or exceeds 40 kg/m2, obesity is said to be "morbid" and the risk of cardiovascular complications increases by about 100% to 400% depending on the type of complications. The risk of mortality increases by 50 to 100% compared to the normal weight population. Obesity and inflammation Adipose tissue accumulates around the abdominal viscera after the fat storage capacity of the subcutaneous territories has been reached. The accumulation of visceral fat is accompanied by a low-grade inflammatory response that is responsible for the secretion of lipid derivatives and mediators toxic to the cardiovascular system and insulin sensitivity. The inflammatory response is characterized by the expression of numerous pro-inflammatory molecules synthesized by adipocytes and immunocompetent single-macrophage cells infiltrating the vascular stroma of adipose tissue. In addition, hyperglycemia and excess lipid intermediates cause the assembly of inflammasomes in the cytosol. Among them, the NLRP3 inflammasome involved in multiple human inflammatory pathologies. Inflammation opposes weight loss, hence the need to reduce the inflammatory response to facilitate weight loss in obese people. Pigeon pea, known for its anti-inflammatory properties, is a legume found in Creole gardens and traditionally eaten at Christmas. The OBESICA study aims at studying the interest of consuming pigeon pea associated with regular physical activity on the inflammatory state of the body and weight loss in obese patients.
NCT04203602
This is a non-inferiority randomized controlled trial aimed to compare the effectiveness and feasibility of performing the ward round using a telepresence robot vs. a face-to-face ward round to discharge patients after bariatric surgery.
NCT02374632
After gastric bypass, 10-20% of patients will obtain a suboptimal weight loss, often defined as \<50% of the excess body weight. Exaggerated meal related secretion of gut hormones seem important for appetite reduction and subsequent weight loss after gastric bypass, however it is not clear whether different gut hormone responses are responsible for different postoperative weight loss responses. The purpose of the study is to investigate gut hormone secretion, vagal integrity and the effect of octreotide on ad libitum food intake in patients with suboptimal weight loss after gastric bypass and compare results to a matched group of gastric bypass operated patients with high postoperative weight loss but similar age, sex and preoperative BMI.
NCT02340247
The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after Roux-en-Y gastric bypass.
NCT02076880
Sleeve gastrectomy is a restrictive procedure based on the removal of a large part of the gastric fundus. According to a recent randomized study, weight loss and resolution of diabetes are comparable to that obtained after gastric by-pass (79.7 % versus 80.3%), but with a lower morbidity. The mechanisms involved in the rapid resolution of diabetes after sleeve gastrectomy remain poorly understood, as no specific study in patients with type 2 diabetic obese are available. An increase in post- absorptive levels of Glucagon-like Peptide 1(GLP-1), Peptide YY(PYY) and insulin has been reported, but in non-diabetic subjects mostly. The important caloric restriction in the early postoperative period indeed improves hepatic insulin resistance, regardless of weight loss. Specific metabolic and hormonal effects of this surgical procedure cannot be excluded.The aim of our study is to explore the early and late metabolic effects of sleeve gastrectomy in severely obese patients with non-insulin-treated type 2 diabetes. We will also evaluate insulin sensitivity, insulin secretion and incretin effect. We will include 14 obese patients with type 2 diabetes, considered eligible to bariatric surgery according to HAS criteria, and whose diabetes treatment involves only metformin, sulfonylurea and glinides. They will be randomized to a 1-week caloric restriction period or no caloric restriction, immediately before surgery. Test meals with dosages of blood glucose, insulin, C-peptide, adiponectin, leptin, GLP-1, PYY and ghrelin will be performed before and after caloric restriction, and 1 week, 3 month, 6 month and 12 month after surgery.
NCT01041131
The main aim of this study is to analyze and report the intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass (RYGB) surgery for failed and/or complicated Vertical Banded Gastroplasty (VBG). The foremost outcome measurements are 1) Fat loss mainly measured as weight loss and expressed as trends in BMI, %EWL, and/or %EBL. 2) Trend in Comorbidity status. 3) Subjective Satisfaction and Health-Related Quality of Life "HR-QoL" are measured by a standardized, non-validated satisfaction questionnaire and by a validated, disease-specific worldwide used HR-QoL questionnaire. 4) Morbidity \& Mortality include nutritional status and metabolic complications. Consequently, secondary objectives of this study are the following. 1) To assess failure rate defined as percentage of excess weight loss \< 50%, lowest BMI \>35 for morbidly obese (MO) or \>40 for superobese (SO), and/or lack of resolution/improvement of major comorbidities at the point in time when assessed at each postoperative year after the surgery under study. 2) To evaluate the metabolic and nutritional status by measurements of particular clinical and biochemical parameters.
NCT01040377
The main aim of this study is to analyze and report traditional, patient-centered, and composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for inadequate initial weight loss.