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100 active trials for Obesity Morbid

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

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.

Start: June 2017
Effect of Automatic Recruitment Maneuver on Peroperative Lung Mechanics of Obese Laparoscopic Abdominal Surgery Patients

This study aims to demonstrate the effects of automatic recruitment maneuver on peroperative lung mechanics of obese patients undergoing laparoscopic abdominal surgery. 128 obese patients undergoing abdominal laparoscopic surgery are randomly going to be assigned to automatic recruitment maneuver group and no recruitment maneuver group (control group). Both groups are going to be taken to the operating table. Electrocardiography (ECG), noninvasive blood pressure (NIBP), pulse oximeter and peripheral oxygen saturation (SpO2) and post-intubation end-tidal carbon dioxide (EtCO2) and train of four (TOF) monitoring will be performed. Then, general anesthesia induction procedure will be started. Following intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal PEEP (Positive end-expiratory pressure) for the patient, and PEEP (Positive end-expiratory pressure) will be adjusted at this value after recruitment. If MAP (mean arterial pressure) is <60 mmHg during the maneuver, the maneuver will be terminated and these patients will be excluded from the study. Respiratory mechanics for both groups (peak pressure, plateau pressure, driver pressure, static compliance, dynamic compliance, EtCO2) and hemodynamic parameters (heart peak, mean arterial pressure, SpO2) at 5 different times (T1: post intubation; T2 : after insufflation; T3: 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver) will be recorded. Throughout the surgery, insufflation pressure will be kept as 10-13 cmH20. At the end of the surgery, the anesthesia maintenance of all patients will be terminated and the routine wake-up phase will be initiated. Creatinine values and hourly urine outputs of all patients routinely monitored at the postoperative 24th hour will be recorded on the case follow-up form.

Start: April 2019
Loop Duodenal Switch: Outcomes at One Year

The biliopancreatic diversion and duodenal switch (BPD-DS) is an accepted and published type of bariatric surgery in the United States. The surgery involves both restriction and malabsorption to achieve weight loss by creating a sleeve gastrectomy as well as two intestinal connections that bypass some of the small intestine, decreasing the amount of food that is absorbed. The BPD-DS procedure produces the most weight loss of any bariatric surgery commonly performed but has the highest risk of malnutrition and gastrointestinal side effects. The loop duodenal switch (L-DS) is a bariatric surgery which has been modified from a biliopancreatic diversion and duodenal switch to maintain excellent weight loss while possibly reducing side effects. The surgical modifications in this procedure include reducing the number of intestinal reconnections from two to one and reducing the amount of small intestine which is bypassed. The L-DS operation is considered experimental by the American Society of Metabolic and Bariatric Surgery as long-term data in large numbers of patients is not available for weight loss or side effects. The purpose of this study is to examine weight loss and other outcomes in the L-DS operation up to 1 year after the procedure. Patient eligibility criteria: between 19-70 years of age at enrollment, BMI ? 40 kg/m2, and the subject is under consideration for surgery for obesity or metabolic disease and elects to undergo a primary loop duodenal switch procedure or as a conversion procedure for failed, sustained weight loss after a sleeve gastrectomy or laparoscopic adjustable gastric band performed more than 12 months prior to time of evaluation. All subjects will undergo a standard comprehensive bariatric surgery evaluation which includes but is not limited to nutrition consultation, psychological evaluation, laboratory tests and supervised medical weight loss. Once the study subjects have met all of the insurance requirements, the bariatric clinic will submit for insurance approval for a duodenal switch operation. Once surgery is approved, study subjects will have a standard pre-operative history and physical visit no more than 30 days prior to surgery and will fill out a survey regarding health-related quality of life and amount of gastrointestinal symptoms experienced (diarrhea, constipation, bloating, etc). This study does not change the number of visits, timing of visits, or laboratory blood draws surgical patients would have with the bariatric surgery clinic or staff. Study subjects will be seen in the clinic at 2 and 6 weeks, and 3, 6, 9, and 12 months per the bariatric surgery center protocol. As part of these normally scheduled visits, weight loss and health status will be recorded. Labs will be checked at 3, 6, and 12 months for nutritional status. A survey to reassess health-related quality of life and gastrointestinal symptoms will be performed at 3 months, 6 months and 12 months.

Start: August 2018