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95 active trials for Bariatric Surgery Candidate

Bone Fragility Evaluation in Obese Patients

This research will study the bone fragility in obese patients, on DXA and CT-scan, in a transversal study. The investigators want also to study the specific risk factors of bone fragility in these obese patients (relationship between body composition on whole body on DXA, fat mass and its location, lean mass, weight loss after surgery and SBAC-L1), to improve the bone screening.

Start: February 2020

Single Anastomosis Duodenal Ileal Bypass (SADI) for Sleeve Revision

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.

Start: October 2019

Obesity Cohort : Medical Follow-up of Severe or Morbid Obese Patients Undergoing Bariatric Surgery

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.

Start: May 2012

Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome

It has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors. Among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (OSA) syndrome. Given the strong associations between OSA and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in OSAS patients.

Start: October 2019

The Effect of Bariatric Surgery on Glucose Metabolism

This prospective, single arm, longitudinal study aims to assess the effect of bariatric surgery on glucose metabolism and kidney function.

Start: November 2018

The Use of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP)

Randomized, Double-Blinded, Placebo-Controlled Trial of Laparoscopic Transverse Abdominis Plane (Lap TAP) and Rectus Sheath Block in elective Gastric Bypass Surgery aiming to evaluate the benefit of a laparoscopically -guided, surgical transversus abdominis plane (TAP) block and rectus sheath block in reducing post-operative opioid consumption and improving outcomes in patients undergoing laparoscopic gastric bypass surgery. The results of this study will provide further evidence on the optimal means to obtain analgesia in patients undergoing gastric bypass surgery

Start: November 2018

The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease

Start: November 2019

GLP1-imaging Before and After Bariatric Surgery

In order to evaluate the difference in beta cell mass in morbidly obese patients with type 2 diabetes mellitus (T2D) before and after Roux-en-Y gastric bypass (RYGB), investigators aim to compare quantitative PET imaging of the pancreas in this patient group before and after surgery. Investigators propose to measure the uptake of 68Ga-NODAGA-exendin-4 in the pancreatic beta cells of these patients. Furthermore, investigators aim to compare uptake of the radiolabeled tracer to beta cell function measured by laboratory parameters. These highly relevant data will provide investigators with more information on the contribution of the beta cells to the mechanisms behind resolution of T2D after bariatric surgery and on the prognostic value of pre-operative beta cell mass determination to T2D resolution. This might be of great interest for the assessment of RYGB as an alternative therapy in patients with T2D and a BMI <35, who currently do not meet the international guidelines for bariatric surgery.

Start: October 2016

Prehabilitation in Bariatric Surgery

Obesity is a major public health problem in our region and constitutes a priority of the Canary Islands Health Plan. Bariatric surgery is the most effective intervention in the treatment of obesity and its complications. However, people with obesity have high surgical risk and long-term outcomes are related to pre-surgical weight loss. In patients currently on the bariatric surgery waiting list, a randomized controlled trial will be performed in which two group interventions will be compared. One of the interventions (standard), will consist of educational modules in food and exercise, combined with cognitive-behavioral therapy. In the other, a specific training (prehabilitation) will be added to encourage physical activity and the conditioning of inspiratory muscles. The pre-surgical weight loss (principal outcome) will be compared between groups, as well as the evolution of the complications of obesity, the functional status of the patients, their physical activity, quality of life, immediate complications of surgery and days of admission.

Start: August 2019

MGB/OAGB and LSG Effects on Lower Esophageal Sphincter (LES) Function

Background While several articles have reported about the effects of laparoscopic sleeve gastrectomy (LSG) on the lower esophageal sphincter (LES), to date, just one paper has discussed this issue with regard the Mini/One anastomosis gastric bypass (MGB/OAGB). This is expected to be the first randomized trial exploring and comparing these two interventions. Setting "Federico II" University Hospital, Naples - ITALY. Methods Fifty morbid obese patients are going to be studied. All patients presenting with a normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 25 pts) or MGB (arm 2 - 25 pts). Patients undergo clinical assessment for reflux symptoms, and esophago-gastro-duodenoscopy (EGDS) plus high-resolution impedance manometry (HRiM) and 24-hour pH-impedance monitoring (MII-pH) before, two months and 1 year after both LSG or MGB/OAGB. Objective Endpoint 1: Does this surgery affect the LES area function in both arm 1 or arm 2 patients determining a possible increase in gastroesophageal acid or non acid reflux? Endpoint 2: Does one between the two procedures outperform the other one in terms of eventual LES area modifications? Endpoint 3: In the case of a good performance of LSG or MGB/OAGB or both the procedures, is this to be primarily related to surgery per se or to weight loss?

Start: January 2016

The Expressive Writing in Bariatric Surgery

The aim of the present study is to test the efficacy of a psychological intervention focused on the expressive writing on the weight loss and adherence, 3 months after surgery in obese population undergoing to bariatric surgery. The sample will be divided into two groups: the expressive writing group that will perform the psychological intervention focused on expressive writing, and the control group that will not perform the psychological intervention. The assignment to the two groups will be randomized. The randomization will be carried out leaving each participant free to blindly choose one of the two sealed envelopes containing the writing instruction sheet and an empty sheet, respectively. All participants will complete psychometric questionnaires 3 days before surgery (T0) and 3 months (T1) after surgery in order to test the predicted variation on the chosen outcome in a very early stage after surgery. In order to assess the adherence level with a non self - report measure, the serum levels of 25(OH)D, B12, sideraemia and iron at T1 will be collected. Moreover, the adherence to follow up visits (surgical, nutritional and psychological) at 1 and 3 months will be assessed. The main hypothesis is that those patients undergoing expressive writing would have a greater early Excess Weight Loss % (EWL%), lower level of psychological impairment and higher level of adherence to treatment 3 months after surgery, compare to those patients who are not undergoing expressive writing.

Start: August 2019

A Preoperative Cognitive Behavioural Therapy Program Based on Self-determination Theory for Bariatric Surgery Candidates

The objective of this study is to evaluate the impact of a pre-surgical intervention program based on Cognitive and Behavioural Emotional Therapies, on the degree of dietary restriction of patients who are candidates for bariatric surgery in order to increase the long-term effectiveness of this kind of surgery

Start: February 2018

Preoperative Dry Lean Body Mass as a Prognostic Factor for Excess Weight Loss After Bariatric Surgery.

Bariatric surgery is currently the only method that has proven long-term effectiveness in obesity. Although the benefit of physical activity on weight loss has been demonstrated, no correlation has ever been reported between preoperative lean body mass and postoperative weight loss. Dry lean mass is probably an essential prognostic factor for the effectiveness of bariatric surgery. The main objective of this study is to define a preoperative dry lean body mass threshold as a worst prognostic factor for weight loss one year after bariatric surgery. The management of patients included in this study was modelled on the management usually offered to patients followed for the same pathology in the diabeto-endocrinology department. There are no study-specific examinations that are not part of current practice.

Start: October 2018

DS vs SIPS-Bariatric Surgery Comparasion

The aim of this study is to answer the question of whether the single anastomosis, 300 cm loop, duodenal switch (SIPS) is an equally effective, safe, simpler operation with less nutritional and surgical risks than the standard duodenal switch (DS) operation. Please note, this study does not provide a stipend or coverage for surgery.

Start: January 2017

Pathogenesis of Non-alcoholic Steatohepatitis and Liver Regeneration After Bariatric Surgery

Obesity and obesity related health problems are globally recognized as one of the major threats to public health. Bariatric surgery is the most effective and durable therapy option for obesity and the improvement of obesity related co-morbidities. "Non alcoholic steatohepatitis" (NASH) is an important comorbidity of obesity and improves after surgical intervention. In this study investigators try to enlighten the weight independent mechanism for the effects of bariatric surgery. Patients who are assigned to a bariatric procedure will be observed for at least 24 month. A liver and adipose tissue samples are gained during the operation. Liver function and morphology are observed before and after operation with LiMAx, FibroScan and ultrasound. Systemic inflammation is measured in blood samples before and after surgical intervention. In order to check the microbiome stool samples are collected throughout the entire observation period.

Start: June 2016