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Roux-en-Y Gastric Bypass clinical trials

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NCT ID: NCT03440138 Completed - Bariatric Surgery Clinical Trials

Defining Benchmarks in Bariatric Surgery

BBenchmarks
Start date: October 17, 2017
Phase:
Study type: Observational

Aim: To define benchmark outcomes in minimally-invasive primary bariatric surgery. Design: Multicenter retrospective cohort study. Assessed outcomes: Morbidity as defined by the Clavien-Dindo classification for surgical complications, the Comprehensive Complication Index® (CCI®) at discharge, at 3 months and at latest follow-up. Evolution of body mass index (BMI) will be also analyzed. Hospital eligibility: High volume centers (> 200 bariatric operations per year) from at least three continents, maintaining a prospective database, as well as having published previously critically on their outcome. Study population: Adult patients who underwent primary minimally invasive (laparoscopic / robotic) Roux-en-Y gastric bypass or sleeve gastrectomy from 1st of June 2012 to 31st of May 2017. Patient Exclusion criteria: detailed later. Data collection Deadline: 1st September 2017 - 30 April 2018

NCT ID: NCT03407833 Enrolling by invitation - Obesity Clinical Trials

Physiologic and Functional Adaptations of Insulin Sensitive Tissues

Start date: February 13, 2018
Phase:
Study type: Observational

The long-term goal is to understand the mechanisms of intestinal nutrient sensing and signal relays to insulin sensitive tissues (adipose, skeletal muscle, liver) in humans. The investigators hypothesize that human tissue biopsies (from obese surgery and non-surgery subjects as well as lean controls) can be used to understand the molecular mechanisms underlying intestinal nutrient sensing and signal relay in humans. The investigator will obtain tissue specimens from patients during scheduled upper endoscopies, colonoscopies and scheduled metabolic and bariatric surgeries or liver transplantation. A blood sample (4mL) will be obtained concurrent with these procedures. From metabolic and bariatric surgery subjects blood and tissues (liver, adipose, small intestine, omentum, skeletal muscle) can be collected at the time of surgery. From liver transplantation patients, excised liver tissue will be collected. Stool can be obtained preoperatively and at various time points after surgery. Some bariatric surgery subjects will participate in a mixed-meal tolerance test at their pre-operative visit and several post-operative visits to compare the whole-body metabolic alterations following bariatric procedures.

NCT ID: NCT03331536 Completed - Osteoporosis Clinical Trials

Skeletal Health in Bariatric Surgery Patients

Start date: March 22, 2018
Phase:
Study type: Observational

The investigators propose a prospective cohort trial that will help to understand the impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in pre- and post-menopausal female bariatric patients.

NCT ID: NCT03049696 Active, not recruiting - Obesity Clinical Trials

Does Participation in a Pre-Operative Physical Activity Program Improve Patient Outcomes and Quality of Life?

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

The primary objective of the study is to determine whether participation in a pre-bariatric surgery physical activity and behavior modification/education program (ENCOURAGEING START) that is tailored to the unique needs of obese bariatric surgery patients, improves physical fitness, surgical outcomes, patient health and quality of life. Short- (one year) and long- (five year) term outcomes will be compared to matched historical controls (1:1) based on age, gender, and body mass index (BMI) from the existing Manitoba Centre for Metabolic and Bariatric Surgery (CMBS) database. Our findings will determine whether a pre-bariatric surgery physical activity and behavior modification/education program results in improve surgical and patient outcomes and inform the development of evidence-based physical activity (PA) guidelines for bariatric surgery patients and improved CMBS program delivery.

NCT ID: NCT02830789 Completed - Clinical trials for Hyperparathyroidism, Secondary

Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass

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

This study investigates whether calcium citrate or calcium carbonate are the optimal supplement to treat secondary hyperparathyroidism following Roux-en-Y gastric bypass operation. Half of the participants will be randomized to receive calcium citrate, while the other half will receive calcium carbonate. The study will be double blinded.

NCT ID: NCT02741674 Completed - Obesity Clinical Trials

Comparing the Benefits and Harms of Three Types of Weight Loss Surgery -- The PCORnet® Bariatric Study

PBS
Start date: February 2016
Phase:
Study type: Observational

The main goal of this research project is to conduct a comparative effectiveness research study involving existing data in the PCORnet Common Data Model to provide accurate estimates of the 1-, 3-, and 5-year benefits and risks of the three most common bariatric procedures - Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy - with a focus on outcomes that are important to adults and adolescents with severe obesity: 1) changes in weight, 2) rates of remission and relapse of diabetes, and 3) major adverse events.

NCT ID: NCT02228902 Completed - Bariatric Surgery Clinical Trials

Iron Absorption Trial

Start date: August 2014
Phase: Phase 4
Study type: Interventional

Introduction: There are indications that the absorption of oral iron supplementation is reduced after a Roux- en -Y gastric bypass. Nevertheless, oral preparations are used as standard therapy for iron deficiency, even in patients who underwent a Roux- en -Y gastric bypass. Our goal is to evaluate if iron absorption is disturbed after a RYGB, which leads to a insufficient treatment of oral iron suppletion. Methods: an iron absorption test will be performed pre- and postoperatively in 24 patients. Two groups will be created. Preoperatively group 1 receives a daily dose of ferrous fumarate (600mg) and group 2 receives a daily dose Losferron (1390mg). Before intake of the medicines, a fasting blood sample is taken (baseline), serum iron including ferritin, transferrin and transferrin saturation will be measured. After intake of losferron/ferrous fumarate blood samples will be taken 1, 2, 3, 4, 5 and 6 hours after intake, using a drip. An increase of 80 microgram/l is representative for a sufficient iron absorption. All patients undergo a Roux- en -Y gastric bypass. Postoperatively; one month postoperatively the same absorption test will be repeated in the same patients.

NCT ID: NCT02204813 Completed - Bariatric Surgery Clinical Trials

To Define the Role of GLP-1 for Improving Glucose Homeostasis in Humans Following Gastric Bypass Surgery

Start date: July 2014
Phase: Phase 1
Study type: Interventional

There is a marked and long-lasting improvement in glucose homeostasis that follows Roux-en-y gastric bypass surgery (RYGB) in humans. This improvement has been attributed in large part to an intestinal hormone, called GLP-1, that is released into the circulation immediately after eating. The purpose of this study is to determine if GLP-1 mediates the beneficial effects of RYGB surgery on glucose homeostasis in humans.

NCT ID: NCT02173886 Completed - Clinical trials for Roux en Y Gastric Bypass

A Comparison of Sustained and Extended Release Bupropion Following Bariatric Surgery

Start date: June 2014
Phase: Phase 4
Study type: Interventional

This study is being conducted to evaluate how the body absorbs and processes the sustained release (SR) and extended release (XL) medication bupropion (Wellbutrin®). Subject who are 1-3 years post gastric bypass surgery will be invited to participate. Non-surgical controls will also be enrolled based on a matching criteria to post gastric bypass subjects. Participants will be asked to complete two 12-hour study days approximately 11 days apart.

NCT ID: NCT02128581 Completed - Obesity Clinical Trials

A Dose-response of the Effects of Exendin-9,39 on GI Symptoms and Food Intake

Start date: May 2014
Phase: Phase 1
Study type: Interventional

Exendin-(9,39) has been shown to have effects on beta-cell function, and after gastric bypass, to accelerate gastrointestinal transit. - infused at rates of 300pmol/kg/min. Given that gastrointestinal transit is typically delayed by Glucagon-Like Peptide-1 (GLP-1) and also that this hormone causes decreased food intake through increased satiation, it is reasonable to expect an effect of Exendin-9,39 on appetite. This may help explain the effects of gastric bypass on food intake. To examine the effect of Exendin on food intake we propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion. We will examine the presence of gastrointestinal symptoms as well as food intake in the immediate aftermath of a test meal and the subsequent hours.