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Obesity, Morbid clinical trials

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NCT ID: NCT03231423 Completed - Obesity, Morbid Clinical Trials

Effect of Drainage on Laparoscopic Gastric Bypass Surgery

Start date: December 9, 2016
Phase: N/A
Study type: Interventional

Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method. The purpose of this study is to determine the use of drain, which closely affects these criteria; And the effect on patient comfort.

NCT ID: NCT03219658 Completed - Child Obesity Clinical Trials

STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity

STOMP
Start date: October 1, 2017
Phase: N/A
Study type: Interventional

This internal pilot study will determine whether a highly promising primary care based intervention that combines group based parenting skills training and public health nurse home visits with a focus on healthy nutrition, activity and sleep, will lead to improved weight status in 1 to 5 year old children with severe obesity. Children with severe obesity will be identified through the obesity management clinical program at The Hospital for Sick Children called STOMP (SickKids Team Obesity Management Program). The STOMP Early Years Program is a unique and intensive, paediatric obesity management program designed for 1 to 5 year-olds with severe obesity and their families. Families who participate in this study will be randomly assigned (having an equal chance of being in either group) to one of the two study groups that will run for 6 months: Group A: Ten weeks of group parenting education sessions with 2-4 public health nurse home visits and four one-on-one check-ins with an interdisciplinary team at STOMP. Group B: Wait listed to receive parenting education sessions; receive one-on-one checks with an interdisciplinary team at STOMP. In addition to the measures collected as part of STOMP, families will complete the following questionnaires before the start of the trial, and after 6 months: Parenting Scale, Parenting Stress Index, Depression, Anxiety, and Stress Scale (DASS-21), Cost Questionnaire, and Children's Behaviour Questionnaire (CBQ).

NCT ID: NCT03210207 Completed - Weight Loss Clinical Trials

Gastric Plication in Mexican Patients

Start date: September 2016
Phase: N/A
Study type: Observational

Between January and December 2012, a total of 40 patients underwent GLP. The study will assess subject excess weight loss (%EWL) following the study procedure at 3, 6, 12, 36 and 60 months.

NCT ID: NCT03191318 Completed - Morbid Obesity Clinical Trials

Comparison of Enhanced Recovery After Surgery (ERAS) Pathway With Conventional Pathway After Laparoscopic Sleeve Gastrectomy

BARI-ERAS
Start date: September 1, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to compare two postoperative recovery pathways namely, enhanced recovery after surgery (ERAS) pathway and conventional recovery pathway after laparoscopic sleeve gastrectomy with respect to outcomes including hospital stay, postoperative pain and other postoperative outcomes.

NCT ID: NCT03186859 Completed - Clinical trials for Non-Alcoholic Fatty Liver Disease

Effects of Dietary Intervention and Surgery on NAFLD (Non-Alcoholic Fatty Liver Disease)

EDISON
Start date: June 9, 2017
Phase: N/A
Study type: Interventional

Approximately 90% of people undergoing bariatric surgery have NAFLD, which is a condition where fat accumulates in the liver and can lead to inflammation and scarring. It mostly causes no symptoms, however, in the most advanced cases there is an increased risk of liver cancer or liver failure. NAFLD is currently managed by weight loss and treating associated diseases such as diabetes. No medicines have been licensed to directly treat it but bariatric surgery has been shown to be usually beneficial, although it is unknown whether some operations are better than others. It is also unclear whether this is due to general weight loss or other factors. This study will be conducted in a hospital setting and aims to determine what changes in liver fat and fat processing occur after pre-operative low calorie diet and the two most common types of bariatric surgery (Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. Participants will have ten study visits, four of which may be combined with NHS appointments. Participants will undergo investigations including MRI scans to measure changes in NAFLD and DEXA scans to measure changes in fat and fat-free mass (FFM). Participants will also undergo mixed meal testing to which stable isotopes (deuterated water and 13c-palmitate) will be added to allow changes in fat processing to be detected. In addition to samples taken as part of NHS care, blood, urine, liver and fat (visceral and subcutaneous (abdominal and gluteal)) will be used for research. Visits will take place before and after low calorie diet and bariatric surgery.

NCT ID: NCT03185949 Completed - Obesity, Morbid Clinical Trials

The Lowering Weight in Severe Obesity by Embolization of the Gastric Artery Trial

LOSEIT
Start date: February 8, 2017
Phase: N/A
Study type: Interventional

To evaluate the efficacy and safety of the Endobar gastric embolization system for the treatment of obesity before continuing to a larger Pivotal Trial. Investigational Device The investigational device in this clinical study is the Endobar Infusion Catheter System - a disposable system consisting of an occlusion balloon catheter, a Smart Manifold delivery system. Study Design/Planned Number of Subjects This study is a prospective, sham controlled, single-blind 12-month trial with 1:1 randomization. A maximum of 40 subjects (obese men and women who have a body mass index (BMI) of 35.0-50.0 kg/m2) will be enrolled in the study. Eligible subjects will be randomized to treatment with Endobar Therapy (n = 20) or sham procedure control (n = 20). Endobar Therapy involves catheter-based embolization of the left gastric artery. All subjects in both Endobar Therapy and Sham Control groups will receive Lifestyle Therapy (behavioral and diet education). At the end of 6 months all subjects randomized to the Sham Control group will receive catheter-based embolization of the left gastric artery. Both Endobar Therapy and Sham Control crossover to Endobar Therapy groups will be followed for a total of 12 months. Study Duration The duration of the study is expected to last approximately 18 months from the first enrollment . An additional 12 months to the study closeout after the last follow-up.

NCT ID: NCT03181347 Completed - Morbid Obesity Clinical Trials

The Microbiology of Bariatric Surgery

Start date: September 3, 2017
Phase: N/A
Study type: Interventional

Obesity and its associated diseases are increasing worldwide. However, the mechanisms behind the development of obesity is not fully understood. There is evidence that intestinal bacteria may play a role in the development and perpetuation of obesity through regulation of energy and fat storage. Bariatric surgery is currently the most effective modality for treating severe obesity with evidence to support long-term sustained weight loss and improvement in obesity-related comorbidities. The two most commonly performed bariatric surgical procedures are the Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). RYGB leads to greater weight loss than SG and improved diabetes control in patients following surgery. Despite the success of RYGB and SG in inducing weight loss and improving comorbidities, the underlying mechanisms leading to clinical improvement following these operations is not completely understood. Multiple factors are thought to play a role including reduced caloric intake, decreased nutrient absorption, increased satiety, release of hormones and shifts in bile acid metabolism. Recent evidence has suggested that the gut bacteria mediates a number of the beneficial effects of bariatric surgery. Small studies have demonstrated changes in the composition and diversity of the gut microbiota after RYGB and SG in humans. One study also confirmed long-term microbial changes for RYGB. However, comparative trials have been small (less than 15 participants per treatment group) and important differences between specific bacterial populations have not been well elucidated. Furthermore, no human study has examined the differences in bacterial composition following RYGB and SG in relation to their metabolic consequences. The aim of this study is to investigate and compare the metabolic and microbial changes that occur with RYGB, SG, and dietary controls. Specifically, the investigators aim to use a systems biology approach utilizing powerful analytic techniques including metagenomics, metabolomics, and multiplex immune profiling to define the combined microbial, metabolic and immunologic changes that occur after bariatric surgery.

NCT ID: NCT03176615 Completed - Weight Loss Clinical Trials

Meal-induced Thrombin Generation Before and After Gastric Bypass

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate harmful effects of intentional weight loss. Intentional weight loss has been linked to increased risk of cardiovascular disease in overweight individuals, but the link between intentional weight loss and thrombotic disease is poorly understood. Postprandial coagulation activation, including thrombin generation, is a potential mechanism after high-fat meals. Thirty obese patients admitted to gastric bypass will be included in a randomized, cross-over clinical trial. All patients will consume a high-fat meal and a low-fat meal served in a randomized order on two study days (two to seven days apart). This cross-over study will be carried out before weight loss, during lifestyle-induced weight loss, and during weight loss 3-4 months after gastric bypass. Fasting and postprandial blood samples are collected on each study days, while one fecal sample is collected for each study period. The study will contribute to our understanding of mechanisms underlying harmful effects of weight loss, and future, dietary guidelines in relation to intentional weight loss programs must be modified.

NCT ID: NCT03137433 Completed - Pediatric Obesity Clinical Trials

Weight Loss With Meal-Replacement Therapy in Teens

Start date: January 2, 2018
Phase: N/A
Study type: Interventional

This study seeks to examine whether meal-replacement therapy is able to enhance weight loss among teens with severe obesity. In addition, we are also interested in examining the degree of weight loss needed to improve important cardiometabolic risk factors among adolescents.

NCT ID: NCT03115632 Completed - Obesity Clinical Trials

Contributing Factors in the Pathobiology of Airway Remodeling in Obesity

Start date: April 9, 2018
Phase:
Study type: Observational

There are two aims for this study. The purpose of this study is to determine the effects of body weight and hormones on airway fibrosis (scarring) and lung function in obese & lean asthma subjects compared to obese & lean non-asthma subjects (Aim 1). And in obese subjects with asthma undergoing bariatric surgery compared to obese non-asthma subjects undergoing bariatric surgery (Aim 2).