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56 active trials for Bariatric Surgery

Impacts of Remote Digital Support on Physical Activity for Patients in Bariatric Surgery

Compare the level of PA (physical activity) in groups with and without STIMUL device at 4 months

Start: November 2018
Photographic Food Recognition and Meal Size Estimation Before and After Roux-en-Y Gastric Bypass

Direct measurements of changes in food selection in humans after RYGB have been limited by the unreliability of patients, which poses significant methodological and conceptual challenges to researchers and study design. Self-monitoring requires time and effort, and many find tracking of dietary intake tedious, which contributes to attrition. Direct measurements, however, represent an essential component in the attempt to understand how RYGB alters eating and food preferences, but laboratory settings preclude a real-life environment. The aim of this study is to investigate changes in food preferences, total energy intake of the three primary macronutrients and meal patterns between obese women (BMI ? 35) before and after Roux-en-Y gastric bypass and lean (BMI ? 25) and obese (BMI ? 35) controls by means of photographic food recognition with a mobile application.

Start: June 2019
Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds

The goal of this pilot study is to establish the feasibility and initial efficacy of the combination of phentermine and topiramate for adolescents and young adults who require additional risk reduction after bariatric surgery. This study will use a randomized, placebo-controlled, double-blinded design to evaluate an adjunctive 12-week intervention of phentermine + topiramate + standard of care vs. placebos + standard of care 6 months after bariatric surgery, among 12 to 24 year olds who don't achieve expected weight loss or who remain severely obese (n=10 total).

Start: January 2020
Gaining Optimism After Weight Loss Surgery (GOALS) I

This study examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (PP-MI) intervention for physical activity among patients who have recently undergone bariatric surgery.

Start: July 2021
Gaining Optimism After Weight Loss Surgery (GOALS) II

This randomized controlled trial examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (PP-MI) intervention for physical activity among patients who have recently undergone bariatric surgery compared to an enhanced usual care control.

Start: July 2022
Comparison of Three Hypoabsortive Surgical Techniques for Treatment of Type IV Morbid Obesity

Morbid obesity is the first non-traumatic cause of death in the western population and it is also progressively beginning to affect the developing countries. Bariatric surgery provides better results than pharmacological treatments and lifestyle changes, granting a better control of comorbidities. Duodenal switch (DS) has proben to be the most effective surgical treatment for grade IV morbid obesity and its comorbidities. However, it is not widely used due to its technical complexity and the risk of long-term complications. Single Anastomosis Duodenum-Ileal bypass with Sleeve gastrectomy (SADI-S) was concieved in 2007 as a one-anastomosis simplification of DS, intended to diminish the surgical time and postoperative risks. Recently, another simplified hypo-absorptive technique has started to be widely used: the one anastomosis gastric bypass (OAGBP), also called mini-gastric gypass. It consists of a gastric pouch associated with a gastro-jejunal anastomosis in omega (Billroth II). Despite the potential advantages of these emerging surgical techniques (SADI-S and OAGBP), there is no solid evidence on its efficacy for the treatment of grade IV obesity in comparison with DS. Besides, there is also there is a lack of studies reporting on prospective acid and bile reflux after omega digestive reconstructions, suche as "Billroth II-like" (SADI-S) and "Billroth II" (OAGBP). Bile reflux is potentially premalignant condition. This prospective randomized study aims to compare conventional DS with SADI-S and OAGBP. We include all morbidly obese patients with BMI ? 50 kg/m2 aged 18 years or more. Exclusion criteria are patients who do not fulfill our preoperative bariatric assessment for surgery and those with contraindications for hypo absorptive or mixed surgery. The main objective of the study is to compare the percentage of excess weight lost at 2 and 5 years after the three different surgical procedures. As a secondary objective, gastroesophageal reflux (GERD) will be compared before and 2 years after surgery, based on GERD symptoms test, gastroscopy and a esophageal pH-impedanciometry in selected patients. Other secondary objectives are comparison of short-term complications, metabolic comorbidities, depositional habit, quality of life and metabolic and nutritional deficiencies at two years of surgery.

Start: April 2021
Fat Absorption and Metabolism After Roux-en-Y Gastric Bypass

Using intravenous and oral administration of stable isotope tracers, we will investigate the importance of altered fat absorption and altered whole body fat metabolism for the reduced postprandial systemic TAG concentrations in non-diabetic patients in weight stable phase after RYGB.

Start: April 2021
Naldebain for Pain Control After Bariatric Surgery

Laparoscopic gastric sleeve and bypass surgeries the most common bariatric procedures for weight loss and improved management of metabolic syndromes. Patients may suffer from wound pain or referred pain after laparoscopic bariatric operation. Most importantly, 11.8% of these patients complained surgical-related pain one year after operation, and 8% of them required prolonged use of opioid to control chronic postoperative pain (CPSP). However, there are currently lack of clinical practice guidelines or recommendations for prevention of CPSP after laparoscopic abdominal surgery. Although regional block techniques (i.e. truncal block or intrathecal opioid) are considered as effective supplementary analgesic approaches to improve postoperative pain control, parenteral administration of analgesics remain as the mainstay for pain management of laparoscopic abdominal surgery. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is an extended-release dinalbuphine sebacate, and is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. A number of clinical studies have shown that single-dose of pre-operative intramuscular administration of Naldebain® provides significantly higher analgesic effect up to 1 week in hemorrhoidectomy and laparotomy surgery with a well-tolerated safety profile. Therefore, this PI-initiated randomized, double-blind, placebo-control trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in patients receiving laparoscopic gastric sleeve or bypass surgery, and prevention of the development of CPSP after surgery. This study will also analyze the plasma levels of nalbuphine following a single intramuscular injection in obese patients.

Start: April 2021
How Altered Gut-Brain-Axis Influences Food Choices: Part 1 (Pilot-Study)

Obesity is currently one of the most substantial health burdens. Due to the production of marked and sustained weight loss, bariatric surgery is an increasingly used therapeutic modality to combat obesity and its comorbidities. Surgical rearrangement of the gastrointestinal tract dramatically alters metabolism and hormones, and results in changes in neurological and hypothalamic signalling, including affected gut-brain axis, which coalesce to exert a profound influence on eating behaviour. In this context, many patients self-report changes in appetite, satiety and food preferences. However, the mechanisms of such functional changes, and how they relate to food decision-making remain unknown. In this pilot proof-of-concept study, the investigators propose a novel approach to unravel the effect of bariatric surgery on the neural coding of nutritional attributes and its impact on dietary choices using a combination of brain imaging, neurobehavioural tasks and computational modelling of food behaviour.

Start: April 2021
How Altered Gut-Brain-Axis Influences Food Choices: Part 2 (BrainFood)

Obesity is currently one of the most substantial health burdens. Due to the production of marked and sustained weight loss, bariatric surgery is an increasingly used therapeutic modality to combat obesity and its comorbidities. Surgical rearrangement of the gastrointestinal tract dramatically alters metabolism and hormones, and results in changes in neurological and hypothalamic signalling, including affected gut-brain axis, which coalesce to exert a profound influence on eating behaviour. In this context, many patients self-report changes in appetite, satiety and food preferences. However, the mechanisms of such functional changes, and how they relate to food decision-making and food purchase behaviour remain unknown. In this project, the investigators propose a novel approach using digital receipts from loyalty card to unravel the effect of bariatric surgery on eating and food purchase behaviour in daily life in the second part.

Start: April 2021
New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg

The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI. Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery. To assess the impact of bariatric surgery on pancreatic Magnetic Resonance Imaging (MRI) parameters in severe-obese patients

Start: February 2021
Use of Electroanalgesia in Pain and Pulmonary Function.

It is a consensus in the literature that changes in lifestyle and carbohydrate-rich diet are part of a context that has led to an obesity pandemic. Its treatment is multidisciplinary, however, in many cases, conventional therapy has no effect, requiring surgical intervention. The latter, in turn, is not free of risks and causes important changes in lung function. Therefore, this study aims to evaluate the effect of electroanalgesia through conventional transcutaneous nerve stimulation (TENS) on pulmonary function in the postoperative period of bariatric surgery.

Start: June 2019
Physical Activity Counseling After Bariatric Surgery

This study will examine whether providing physical activity counseling and guidance to patients post bariatric surgery, along with long-term personal follow-up for six months after the surgery, may increase the level of physical activity, and it's effect on anthropometric and functional measures.

Start: March 2021
Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)

In a randomised placebo-controlled trial assess effects of zoledronic acid for prevention of bone and muscle loss after bariatric surgery.

Start: February 2021
Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy

GERD is a prevalent condition worldwide, estimated to be around 20-30 % in North America. Obesity is rapidly increasing with an estimated prevalence of 66% in the adult population in the United States. Presently, bariatric interventions are the only sustainable method to address morbid obesity and its resulting comorbidities. One of the most common restrictive surgeries includes laparoscopic sleeve gastrectomy (LSG). Although very effective for treating obesity, some of these surgeries might cause deleterious effects regarding GERD, due to anatomical modifications. Refractory GERD is defined by lack of symptom control on maximum dose of PPI therapy. Cardia Band Ligation Anti-reflux (CLEAR) procedure utilizes multiple band ligations at the cardia in a 270-degree fashion, resulting in tissue necrosis and scar formation, narrowing the GE junction and enhancing the flap valve system. The investigators hypothesized that CLEAR can be a safe and efficient intervention to improve post bariatric GERD.

Start: May 2021
Comparative Effectiveness of Bariatric Surgery With PROMs

This long-term, nationwide observational data collection repository will obtain patient-reported outcomes from metabolic and bariatric surgery patients. The data will be used in conjunction with clinical outcomes to determine quality, safety, and comparative effectiveness of various metabolic and bariatric procedures.

Start: March 2016
Incretin Hormone Antagonism After Bariatric Surgery

Using the glucagon-like peptide-1 (GLP-1) antagonist exendin(9-39) and the glucose-dependent insulinotropic peptide (GIP) antagonist GIP(3-30), the purpose of this study is to clarify the importance of endogenous GLP-1 and GIP for postprandial glucose metabolism after RYGB and SG in subjects with normal glucose tolerance. We hypothesize that GLP-1 is more important after RYGB, and GIP is more important after SG, for postprandial glucose tolerance and beta-cell function. A group of un-operated subjects with normal glucose tolerance will serve as controls.

Start: July 2019
Role of Dietary Habits in Efficacy of Bariatric Surgery - Study A

The purpose of the study is to evaluate how dietary habits in the post-surgical year impact outcomes of bariatric surgery.

Start: August 2018
Role of Dietary Habits in Efficacy of Bariatric Surgery - Study B

The purpose of the study is to compare dietary habits after bariatric surgery in patients with poor weight loss versus good weight loss outcomes.

Start: January 2019
Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C

The purpose of the study is to test how dietary habit interventions affect patients with poor weight loss outcomes after bariatric surgery.

Start: January 2019
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