Active clinical trials for "Obesity, Morbid"

Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its definition is still evolving. Patients with this syndrome are at increased risk for cardiovascular disease, and at increased risk of mortality from cardiovascular disease. Metabolic syndrome is strongly associated with obesity, and more specifically with abdominal obesity. Abdominal obesity, comprises two main components: visceral (VAT) and subcutaneous (SAT) adipose tissue depots, with VAT reported as more metabolically active than SAT, and thought to play a major role in the metabolic disturbances associated with obesity and metabolic syndrome. Non-alcoholic fatty liver disease (NAFLD) is fast becoming the most common liver disease and is associated with obesity, insulin resistance and metabolic syndrome. Bariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome, NAFLD, and nonalcoholic steatohepatitis (NASH) in obese patients.

This study aims to characterize the neurological basis of obesity and response to surgical and medical treatment by inducing adult pluripotent stem cells into neuronal cells from subjects that have demonstrated extreme response to bariatric surgery or pharmacological treatment for obesity.

A research study to find out more about a specific white blood cell called a dendritic cell. These cells are found in a layer of fat in the body called the omentum. The omentum is a layer of fat that covers the bowels (intestines) and protects them. The purpose of this study is to allow us to compare dendritic cells in normal weight individuals to the dendritic cells of people who are extremely overweight. These cells will be collected from the omentum, the layer of fat that covers and protects the bowels (intestines), from the mesentery, which is another layer of fat that surrounds the intestines directly, and from the subcutaneous tissue, which is the layer of fat just under the skin.

The purpose of this study is to see whether care gap(s) exist in the management of obesity and its related conditions in obese patients seen by primary care physicians and specialists. The study will also look at whether there is a compliance and adherence gap that exists in patients prescribed medication for obesity management.

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.

This study aims to evaluate the effects of oral glycine supplementation on plasma glycine concentration, intracellular glutathione (GSH) concentration, plasma acylglycine concentration, urine acylglycine concentration, and insulin resistance in subjects with morbid obesity. This is an open-labelled trial. 20 adults with morbid obesity will be recruited. Following screening and baseline metabolic evaluations, eligible subjects will be given oral glycine supplements for 14 ± 5 days. Upon completing glycine supplementation, subjects will return for their post-supplement metabolic assessment. The investigators hypothesize that oral glycine supplementation in morbidly obese patients normalizes plasma glycine concentration, increases intracellular GSH concentration, increases plasma and urinary acylglycine concentration, and improves insulin resistance.

To study the kinetics of release after bariatric surgery of selected polluants stored in adipose tissue, looking for clinical and/or predictive factors To test the hypothesis of a deleterious effect of this release on the expected improvement of insulin-resistance and on the liver inflammation. To determine the level of contamination of morbidly obese patients, with or without metabolic syndrome, compared to a control, non obese population, with special attention to clinical (age, gender, reproductive history, pregnancy, nursing) and biological parameters (insulin-resistance, inflammation).

Background: The investigators have found that obesity and insulin resistance result in significantly increased brain insulin-stimulated glucose uptake, whereas in every other tissue glucose uptake is lower in the obese compared to lean individuals. One possible explanation to this could be central inflammation and activation of brain glial cells, which has been shown to occur in animal models of obesity. Aims: The objective of this study is to investigate whether there is brain inflammation in human obesity, and whether weight loss following bariatric surgery decreases brain inflammation. Methods: A total of 60 morbidly obese subjects, assigned for Roux-en-Y gastric bypass or for sleeve gastrectomy according to routine treatment protocols will be recruited for this study. A control group of 30 healthy subjects will also be recruited. The following studies will be performed to patients and healthy subjects: 1) structural MRI and MRS, 2) functional MRI, 3) PET imaging of cerebral inflammation and astrocyte activation using [11C]-PK11195, 4) measurement of whole-body and tissue insulin sensitivity by combining hyperinsulinemic, euglycemic clamp with [18F]-FDG-PET, 5) neuropsychological testing. The study procedures will be repeated for the morbidly obese 6 months postoperatively.

Participants 60 Patients seeking treatment at the Obesity Unit of the Medica Sur Hospital in México City, Mexico. Informed consent to participate will be aleatory assigned to a three different conditions. Procedures In the initial interview, prospective participants will be provided with detailed information about the study and the treatments. All patients included in the study will be randomly assigned to the one (N=20) of the three treatment conditions described below, all conducted on an inpatient basis. The duration for all treatments will be 6 weeks and will be administered by two chartered clinical psychologists and one chartered psychotherapist under the supervision of a senior chartered psychotherapist. The three therapists will be balanced among the three conditions. Nutritional groups In this condition (NT) the participants (N=20) subjects enter only 5 weekly nutritional groups held by dieticians based on the LEARN manual (Brownell, 1985), whose goal will be to provide practical guidelines for the self-monitoring of eating and lessons on nutrition (e.g stressing gradual weight loss with the caloric restriction achieved largely by reductions in fat intake), plus a low-calorie diet (1,200 kcal/day) and physical training (30 min of walking two times a week as a minimum). Cognitive-Behavioral therapy CBT group (N=20) will be based on the same treatment proposed in the first condition plus 15 additional sessions over 6 weeks. Therapists will follow a detailed manual that outlined the content of each session. This manual was based on the cognitive-behavioral treatment approach described by Cooper and colleagues (Cooper & Fairburn, 2002; Cooper et al., 2003). It was developed during a year of intensive pilot work and adapted to the in-patient setting. Patients will be taught to self-monitor their food intake and eating patterns and thoughts, as well as the circumstances and environment surrounding eating (e.g. whether eating alone or with others, speed of eating, and place of eating). Patients will also be taught to identify problems in eating, mood, and thinking patterns and to gradually develop alternative patterns. In particular, after the first week the patients will enter 5 weekly group sessions aimed at addressing weight and primary goals, and 10 biweekly individual sessions aimed at establishing and maintaining weight loss, addressing barriers to weight loss, increasing activity, addressing body image concerns and supporting weight maintenance. Experiential Cognitive therapy Experiential CT group (N=4) involved the same treatment proposed in the first condition plus 15 additional sessions over 4/6 weeks. In the sessions we will use the "20/20/20 rule". During the first 20 minutes, the therapist focus on getting a clear understanding of the patient's current concerns, level of general functioning, and the experiences related to food. This part of the session tends to be characterized by patients doing most of the talking, although therapist guides with questions and reflection to get a sense of the patient's current status. The second 20 minutes is devoted to the virtual reality experience. During this part of the session the patient enters the virtual environment and faces a specific critical situation (Kitchen, Supermarket, Pub, Restaurant, Gymnasium, etc.). Here the patient is helped in developing specific strategies for avoiding and/or coping with it. In the final 20 minutes the therapist explores the patient's understanding of what happened in VR and the specific reactions - emotional and behavioral - to the different situations experienced. If needed, some new strategies for coping with the VR situations are presented and discussed. To support the empowerment process, the therapists follow the Socratic style: they use a series of questions, related to the contents of the virtual environment, to help clients synthesize information and reach conclusions on their own. In accordance with informed consent, assessments will be obtained before treatment, at posttreatment, 3 and 6 months after the treatment conclusion.

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.