View clinical trials related to Bariatric Surgery Candidate.
Filter by:In this explorative randomized clinical study, the investigators aim to study metabolic, cellular, and molecular changes that occur during weight loss in obese subjects with and without type 2 diabetes. Using novel "imiomics" (imaging technique using PET/MR bioinformatics) analyses to examine possible metabolic differences between energy restricted diet and gastric by-pass surgery on whole-body and tissue specific insulin sensitivity, glucose tolerance, metabolite and protein profiles, fatty acid metabolism, ectopic fat content, and gene expression in adipose tissue. This study aims to identify novel biomarkers and drug targets for type 2 diabetes as well as validate promising and established biomarkers in an interventional model for improved glucose metabolism.
Background While several articles have reported about the effects of laparoscopic sleeve gastrectomy (LSG) on the lower esophageal sphincter (LES), to date, just one paper has discussed this issue with regard the Mini/One anastomosis gastric bypass (MGB/OAGB). This is expected to be the first randomized trial exploring and comparing these two interventions. Setting "Federico II" University Hospital, Naples - ITALY. Methods Fifty morbid obese patients are going to be studied. All patients presenting with a normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 25 pts) or MGB (arm 2 - 25 pts). Patients undergo clinical assessment for reflux symptoms, and esophago-gastro-duodenoscopy (EGDS) plus high-resolution impedance manometry (HRiM) and 24-hour pH-impedance monitoring (MII-pH) before, two months and 1 year after both LSG or MGB/OAGB. Objective Endpoint 1: Does this surgery affect the LES area function in both arm 1 or arm 2 patients determining a possible increase in gastroesophageal acid or non acid reflux? Endpoint 2: Does one between the two procedures outperform the other one in terms of eventual LES area modifications? Endpoint 3: In the case of a good performance of LSG or MGB/OAGB or both the procedures, is this to be primarily related to surgery per se or to weight loss?
Obesity and obesity related health problems are globally recognized as one of the major threats to public health. Bariatric surgery is the most effective and durable therapy option for obesity and the improvement of obesity related co-morbidities. "Non alcoholic steatohepatitis" (NASH) is an important comorbidity of obesity and improves after surgical intervention. In this study investigators try to enlighten the weight independent mechanism for the effects of bariatric surgery. Patients who are assigned to a bariatric procedure will be observed for at least 24 month. A liver and adipose tissue samples are gained during the operation. Liver function and morphology are observed before and after operation with LiMAx, FibroScan and ultrasound. Systemic inflammation is measured in blood samples before and after surgical intervention. In order to check the microbiome stool samples are collected throughout the entire observation period.
The aim of the study is to investigate, if bariatric surgery or the related caloric restriction causes the significant improvement of glucose metabolism, which has been found in bariatric patients.
The use of bariatric surgery has risen subsequently over the last decade, especially in women of reproductive age. (Unplanned) pregnancies in this subgroup are not rare because of e.g. an increased fertility (because of the weight loss) and a possible ineffectiveness of contraceptives (because of a malabsorption in the intestine). Although a pregnancy after bariatric surgery is generally known as safe, there are a few studies that indicate that a pregnancy after a bariatric surgery is not always without complications, and that it should be considered as a high risk pregnancy. The research on pregnancy outcomes after this type of surgery is rather limited to a few small, mainly retrospective, observational case-control and cohort studies and a limited amount of case studies. For risk- and prognose related issues, e.g. the effect of bariatric surgery on fertility, timing of the pregnancy, development of complications during the pregnancy and pregnancy outcomes, large prospective cohort studies are needed. Besides, breast feeding practices and breast milk composition have scarcely been investigated in this population. The energy content of breast milk could possibly be influenced by a state of malabsorption after the procedure. Low amounts of vitamin B12 have also been noticed in the breast milk of women the surgery. The overall objective of this study is to establish a group of women at reproductive age (age 18-45) with a history of bariatric surgery and to generate an extensive database for future analysis. The final goal of the researchers is to develop guidelines or recommendations on how to manage pregnancies after bariatric surgery, based on large-scale prospective research. The study design is a multicentric observational and prospective cohort study. Participants will be followed from the moment of surgery until 6 months postpartum and they can be included on several time points (before surgery, after surgery (<12 months); after surgery (>12 months) or during the pregnancy). Both retrospective and prospective data concerning the medical background, fertility (menstrual cycle), lifestyle (e.a. food, physical activities, smoking, sleeping), blood samples, psychological factors (fear and depression), sexuality, quality of life and pregnancy outcomes will be collected. Data collection by the investigators will happen in a web-based database and by direct online registration by the subjects.
The aim of our study is to assess the concentrations of different oral contraceptive agents in morbid obese women before and after two types of bariatric surgeries (RYGB and sleeve gastrectomy) in order to study the role of the surgery and the role of body weight on drug concentrations, and to compare these concentrations with those of normal-weight women.
Bariatric surgery procedures induce weight loss through restriction and/or malabsorption. The mechanisms underlying type 2 diabetes remission and others metabolic improvements after Roux-en-Y Gastric Bypass (RYGB), sleeve gastrectomy (SG) or biliopancreatic diversion with duodenal switch (BPD-DS) have not yet been formally studied. The investigators propose a longitudinal study with the overall objective of measuring the long-term impact of these three bariatric surgeries (RYGB, SG, BPD-DS) on metabolic, renal and cardiovascular fate in patients with type 2 diabetes. The investigators overall hypothesis is that some bariatric procedures generate hitherto unrecognized effects on many disease-related outcomes, which greatly contributes to their beneficial impact in diabetic patients. The investigators propose 3 specific aims: 1) to establish the long term effect of the three surgeries on the metabolic recovery and quality of life in groups of diabetic patients treated with insulin, hypoglycemic agents or diet; 2) to establish the long term impact of the three surgeries on renal and cardiovascular functions in subgroup of patients with these conditions; 3) to compare metabolic impact of surgeries to those of best medical care for diabetes in a non-surgical control group. For most severely obese patients, lifestyle interventions, perhaps effective in inducing short-lived weight losses, are ineffective for long-term weight loss maintenance and durable metabolic recovery. The increasing popularity of obesity surgeries calls for a better understanding of the underlying mechanisms. This is especially true and urgent when considering that knowledge on the relative impact of each procedure (i.e. SG vs. RYGB and BPD-DS) in resolving T2D is still limited. Better knowledge on each of the procedures will allow stronger scientific rationale for selecting the right surgery for the right patient and improve care for the severely obese individual.
The proposed project will help to understand the changes in reinforcement and impairment experienced by Roux en Y bariatric surgery (RYGB) patients who consume alcohol. In this study the investigators propose to investigate RYGB patients with a prospective, longitudinal design. Investigators will examine driving impairment before and after surgery as well as study cognitive changes and reinforcement changes that may occur in RYGB patients while consuming alcohol. Finally, investigators aim to better characterize the changes that occur in the pharmacokinetics of alcohol following bariatric surgery and examine key variables which may play a role in the development in alcohol use disorders.
The aim of this cohort is to evaluate the follow-up of morbidly obese patients treated by several types of bariatric procedures. In addition, this study could lead to the development of clinical trials on assessment of the bariatric surgery impact.
Obesity is a growing problem worldwide and its prevention has become one of the leading priorities for the World Health Organisation. Obesity results from chronic imbalance between energy intake and energy expenditure. Although early prevention of obesity is preferable, surgical treatment is often required for severely obese people. Bariatric surgery has been shown to be the most effective therapy for severe obesity. Weight loss following bariatric surgery results in significant improvements in coexisting comorbidities, such as diabetes and hypertension but there is controversy whether bariatric surgery also improves aerobic capacity. The purpose of this study is to investigate the effects of bariatric surgery on cardiopulmonary function and on daily physical activity. It is hypothesized that bariatric surgery will improve aerobic capacity and result in beneficial lifestyle changes from sedentary to more active.