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Obesity, Morbid clinical trials

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NCT ID: NCT04433338 Active, not recruiting - Morbid Obesity Clinical Trials

The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery

Start date: September 29, 2020
Phase: N/A
Study type: Interventional

Bariatric guidelines recommend preoperative weight loss of 5% to reduce the risk of surgical complications. However, results in the literature on the improvement of surgical procedure and outcomes are still conflicting. This study aims to evaluate the effect of preoperative weight loss by means of a 14-day low-calorie diet in bariatric patients on operative time, the ease of the Roux-en-Y gastric bypass (RYGB) procedure and long-term weight loss in a real-life experimental setting.

NCT ID: NCT04357119 Active, not recruiting - Weight Loss Clinical Trials

Common Limb Length in One-anastomosis Gastric Bypass

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

Evaluation of the effect of the common limb length on the outcome of laparoscopic single anastomosis gastric bypass in morbidly obese patients. Two groups of patients: one group with a common limb length of about 200 cm distal to the ligament of Treitz and the second group with a common limb length of 300 cm proximal to the ileocecal valve. Groups are evaluated regarding percentage of excess weight loss, resolution of comorbidities, and long term complications.

NCT ID: NCT04343469 Active, not recruiting - Morbid Obesity Clinical Trials

Effects of Morbid Obesity and Bariatric Surgery on Brain Inflammation, and Activation of Central Reward System

BARIBRAIN
Start date: February 11, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04219787 Active, not recruiting - Hypertension Clinical Trials

Different Limb Lengths in Gastric Bypass Surgery

SLIM
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions in the developed world. In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and relief of co-morbidities in the majority of patients. One of the most frequently performed operations is the laparoscopic proximal Roux-en-Y gastric bypass (LRYGB). There is still lack of knowledge why some patients respond much better than others to an identically performed procedure. Therefore, a number of variations of this operation have been introduced over the past 50 years. Increasing the length of small bowel being bypassed has the potential to improve the effect of the operation but buries the risk of nutrient deficiencies. The metabolic effect of LRYGB occurs, in part, independently of weight loss. The mechanisms underlying metabolic improvement through metabolic surgery are not yet fully understood.

NCT ID: NCT04165694 Active, not recruiting - Clinical trials for Bariatric Surgery Candidate

Single Anastomosis Duodenal Ileal Bypass (SADI) for Sleeve Revision

SADI
Start date: October 15, 2019
Phase: N/A
Study type: Interventional

The goal of this study is two part: 1) to add to the literature which is still somewhat sparse with numbers of patients undergoing the Single Anastomosis Duodenal Ileal Bypass (SADI) as a revision for laparoscopic sleeve gastrectomy (LSG) and 2) to have a treatment option for our Kaiser Permanente patients who seek additional assistance after a LSG with persistent morbid obesity and the comorbidities that come with it.

NCT ID: NCT04134156 Active, not recruiting - Morbid Obesity Clinical Trials

Sleeve Gastrectomy Versus One-anastomosis Gastric Bypass: Randomized Trial

Start date: March 1, 2016
Phase: N/A
Study type: Interventional

Hormonal changes after SG and OAGB involve alterations in the levels of many enteric hormones, among these hormones are ghrelin and glucagon-like peptide-1 (GLP-1). Ghrelin is an orexigenic hormone that stimulates food intake and has a documented role in the development of obesity. While ghrelin levels decrease significantly after SG as the fundus, which is the main source of that hormone, is completely removed, they tend to increase after OAGB GLP-1 plays an important role in glucose homeostasis via affecting food intake and satiety. It enhances insulin secretion, stimulates the proliferation and growth of pancreatic beta cells, inhibits food and water intake, and promotes satiety. Some studies reported that both OAGB and SG are followed by increased GLP-1 levels. We conducted this randomized study to compare SG and OAGB with regards to weight loss, comorbidity resolution, changes in ghrelin and GLP-1 hormones, and complications.

NCT ID: NCT04063098 Active, not recruiting - Obesity, Morbid Clinical Trials

Glucose-homeostasis After Endoscopic Sleeve Gastroplasty

Start date: January 30, 2020
Phase: N/A
Study type: Interventional

Endoscopic sleeve gastroplasty (ESG) is a transoral endoscopic procedure that creates a tubular sleeve along the lesser curvature with a gastric volume of approximately 30%. Summarizing the available literature published since its introduction in 2013, ESG was capable to achieve > 10% of sustained total body weight loss in a majority of mildly to moderately obese patients with the caveat of only minor adverse events. Besides weight loss, little is known about the metabolic effects of ESG. The present study seeks to measure markers of glucose homeostasis during oral glucose tolerance tests before and subsequently after application of ESG in 12 patients.

NCT ID: NCT04007393 Active, not recruiting - Adolescent Obesity Clinical Trials

SMART Use of Medication for the Treatment of Adolescent Severe Obesity

SMART
Start date: November 21, 2019
Phase: Phase 2
Study type: Interventional

This study will examine the timing and sequence of using adjunct obesity pharmacotherapy for adolescents with severe obesity who do not respond to lifestyle modification therapy alone.

NCT ID: NCT03880162 Active, not recruiting - PreDiabetes Clinical Trials

Metabolic Effects of a Low Carbohydrate Versus a Standard Diet in Morbidly Obese With Prediabetes

CaPrO
Start date: May 13, 2019
Phase: N/A
Study type: Interventional

To investigate the metabolic effects of a low carbohydrate versus energy-matched standard diet in morbidly obese individuals with prediabetes awaiting bariatric surgery.

NCT ID: NCT03610256 Active, not recruiting - Obesity, Morbid Clinical Trials

Single-anastomosis Duodeno Ileal Bypass (SADI) Versus Roux-en-Y Gastric Bypass

SADISLEEVE
Start date: October 18, 2018
Phase: N/A
Study type: Interventional

Obesity is a major public health problem worldwide. Bariatric surgery has proved to be the most effective treatment of morbid obesity in terms of weight reduction and remission of co-morbid conditions during long-term follow-up. Nowadays, France is ranked 3rd in terms of bariatric surgeries performed per year. Since the laparoscopic Roux-en-Y gastric bypass (RYGB) was described in 1977, this restrictive and malabsorptive procedure has become a gold standard for morbid obesity with an average Excess Weight Loss % (EWL%) of 72% at 2 years, and a strong metabolic effect, especially with regard to type 2 diabetes remission. Nevertheless, failures are observed (up to 20%), particularly in super obese patients, which are then difficult to manage. In this population, biliopancreatic diversion with duodenal switch (BPD-DS) is indicated due to its stronger weight loss and metabolic effect, but is still little performed worldwide because of its higher morbidity, surgical complexity and risk of malnutrition. A novel technique combining the physiological advantages of pylorus preservation and the technical benefits of single-loop reconstruction was introduced in 2007 by Sanchez-Pernaute, who described the single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) as an evolution of the BPD-DS. With a 2.5-meter common channel, SADI-S seems to offer good results for the treatment of both morbid obesity and its metabolic complications, with an EWL% of up to 95% at 2 years and potentially less nutritional consequences. To date, there is only one Spanish randomized trial comparing SADI-S to BPD-DS, whereas BPD-DS represents less than 1% of bariatric procedures in France and is only allowed in super obese patients. Thus only preliminary data of poor scientific value exists. Nevertheless, facing very encouraging short-term outcomes, there is a real need for a prospective trial comparing SADI-S to a standard bariatric procedure. The aim of the investigator's study is to assess weight loss efficiency and the morbi-mortality of the SADI-S in comparison to a standard (RYGB), in order to validate this procedure among bariatric techniques HYPOTHESIS SADI-S is superior to the standard RYGB for weight loss, increasing the EWL% by 10% (82% vs 72%, respectively) at 2 years.