Active clinical trials for "Obesity, Morbid"

Our primary objective is to assess the effect of Liraglutide on weight loss in patients who have undergone secondary bariatric surgeries. We set out to assess if Liraglutide is a viable option to augment weight loss in said category.

Weight-reducing obesity surgery (OS) generally gives good results but complications are common; e.g. impaired weight loss, weight regain, bowel pain, diarrhea, vitamin/mineral deficiency, osteoporosis and impaired dental health. The BASUN study is a prospective 10-year comparison of 1000 surgically and 400 conventionally treated individuals regarding adverse side-effects, risk factors for complications and poor outcome.

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on hydrochlorothiazide are investigated.

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on apixaban.

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.

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on lamotrigine are investigated.

In the proposed study, we will be evaluating the effects of pylorus sparing antral myotomy alone, without concomitant endoscopic sleeve gastroplasty (ESG), on weight loss for subjects undergoing the procedure with a history of obesity. This is referred to as Bariatric Endoscopic Antral Myotomy (BEAM). To better understand treatment effects, we will track weight loss, gastric emptying with gastric emptying breath tests (GEBT), and gut hormones (i.e. ghrelin). This pilot, single-center, randomized, controlled, clinical study aims to assess the safety, tolerability, and short-term efficacy of BEAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial that could be submitted for NIH grant funding.

The worldwide obesity epidemic has led to an increase in the proportion of patients with chronic liver disease due to non-alcoholic fatty liver disease (NAFLD) and in the prevalence of obesity in patients with cirrhosis of all etiologies. The reported prevalence of obesity in patients with cirrhosis is of 30% which appears similar to that of the general population. Bariatric surgery is currently considered as the most effective and durable means for the management of morbid obesity as it is associated with the remission and/or improvement of many obesity associated comorbidities as well as improved quality and expectancy of life. However, the surgical risk is increased compared to individuals without cirrhosis, and determining the risk/benefit ratio of bariatric surgery in the setting of cirrhosis is a complex task further hampered by the lack of randomized controlled trials. The Nationwide Inpatient Sample study reported a slightly increased rate of mortality of bariatric surgery in the setting of compensated cirrhosis compared to individuals without cirrhosis (0.9% vs 0.3%). Interestingly, this risk was as high as 16.3% in individuals with decompensated cirrhosis (16.3%). However, this study has been published more than 10 years ago and the mortality of bariatric surgery has decreased significantly and is around 0.1%. Furthermore, the introduction of transient elastography in clinical practice has allowed the early identification of patients with chronic liver disease (CLD) at risk of developing clinically significant portal hypertension (CSPH). A few series including a limited number of patients have been published indicating that CSPH should not be considered as a formal contraindication for bariatric surgery. This study is meant to assess the outcomes of bariatric surgery in patients with morbid obesity and compensated advanced chronic liver disease (cACLD) (currently synonymous of the term "compensated cirrhosis'') associated with clinically significant portal hypertension (CSPH) in a large multicentric, multinational series.

Background: Revisional bariatric surgery (RBS) represents a further solution for patients who experience an inadequate response following initial bariatric surgery or significant weight regain following an initial satisfactory response. Studies including the follow-up of patients with complications after RBS are still lacking. Aim: to analyze the trend, mortality, and complications at 30 days after RBS in Italy. Secondary aim: 30-day readmission rate, reoperations for any reason related to bariatric surgery. Design: longitudinal, prospective, multicenter study. Time interval: 10 months October 2021 - July 2022). Setting: 11 high-volume bariatric centers of the Italian National Health Service (SSN), university hospitals, hospitals, accredited private centers. Methods: All patients undergoing RBS from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering indications, technique, mortality, intraoperative and perioperative complications, readmission for any reason. All participating centers follow the same preoperative work-up protocol, indications, informed consent, and postoperative follow-up, including scheduled telephone and outpatient visits after 7, 15 and 30 postoperative days. Inclusion criteria: revisional procedures; no concomitant procedure, but hiatal hernia repair; age >18<60 years; compensated comorbidities; informed consent including COVID-19 addendum; adherence to specific admission, in-hospital and follow-up protocols. Patients undergone RBS during 2016-2020 will be considered a control group. The study will not involve any modification of the usual protocols. Statistical analyze: to make qualitative quantitative comparison regarding clinical and anthropometric factors between the two study groups (2021-22; 2016-20), the z-test for two proportions and t-test (two-tailed) will be used, respectively. The significance is fixed at 0.05 and all analyzes will be performed with the SPSS v.27 software. Expected results: enroll about 500 patients to obtain information on the safety of RBS and the current trends in Italy.

Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year, 2-year, and 3-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health.