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Bariatric Surgery Candidate clinical trials

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NCT ID: NCT03638843 Completed - Obesity Clinical Trials

Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2

Start date: September 25, 2020
Phase: N/A
Study type: Interventional

Rapid metabolic improvements seen with sleeve gastrectomy are likely a result of changes in gastric origin. The gastric mucosa is an endocrine organ that regulates satiation pathways and is a complex regulator of food intake as well as lipid and glucose metabolism. This study aims to assess the efficacy and safety of endoscopic selective gastric mucosal devitalization (GMD) for the management of obesity and its related comorbidities.

NCT ID: NCT03620773 Active, not recruiting - Obesity Clinical Trials

Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes

IMPROVE-T2D
Start date: October 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Type 2 diabetes (T2D) in youth is increasing in prevalence in parallel with the obesity epidemic. In the US, almost half of patients with renal failure have DKD, and ≥80% have T2D. Compared to adult-onset T2D, youth with T2D have a more aggressive phenotype with greater insulin resistance (IR), more rapid β-cell decline and higher prevalence of diabetic kidney disease (DKD), arguing for separate and dedicated studies in youth-onset T2D. Early DKD is characterized by changes in intrarenal hemodynamic function, including increased renal plasma flow (RPF) and glomerular pressure with resultant hyperfiltration, is common in Y-T2D, and predicts progressive DKD. Studies evaluating the two currently approved medications for treating T2D in youth (metformin and insulin) have shown these medications are not able to improve β-cell function over time in the youth. However, recent evidence suggests that bariatric surgery in adults is associated with improvements in diabetes outcomes, and even T2D remission in many patients. Limited data in youth also supports the benefits of bariatric surgery, regarding weight loss, glycemic control in T2D, and cardio-renal health. While weight loss is important, the acute effect of bariatric surgery on factors such as insulin resistance likely includes weight loss-independent mechanisms. A better understanding of the effects of bariatric surgery on pancreatic function, intrarenal hemodynamics, renal O2 and cardiovascular function is critical to help define mechanisms of surgical benefits, to help identify potential novel future non-surgical approaches to prevent pancreatic failure, DKD and cardiovascular disease. The investigators' overarching hypotheses are that: 1) Y-T2D is associated with IR, pancreatic dysfunction, intrarenal hemodynamic dysfunction, elevated renal O2 consumption and cardiovascular dysfunction which improve with bariatric surgery, 2) The early effect of bariatric surgery on intrarenal hemodynamics is mediated by improvement in IR and weight loss. To address these hypotheses, the investigators will measure GFR, RPF, glomerular pressure and renal O2, in addition to aortic stiffness, β-cell function and insulin sensitivity in youth ages 12-21 with T2D (n=30) before and after vertical sleeve gastrectomy (VSG). To further investigate the mechanisms of renal damage in youth with T2D, two optional procedures are included in the study prior to vertical sleeve gastrectomy: 1) kidney biopsy procedure and 2) induction of induced pluripotent stem cells (iPSCs) to assess morphometrics and genetic expression of renal tissue.

NCT ID: NCT03617185 Active, not recruiting - Obesity Clinical Trials

Effect of Exercise and Surgical Weight Loss on Polyneuropathy

Start date: July 12, 2018
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate how exercise and surgical weight loss affect how likely an individual is to develop peripheral neuropathy and other neurologic complications.

NCT ID: NCT03613766 Completed - Physical Activity Clinical Trials

Physical Activity Program Before Bariatric Surgery

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

Background: Weight reduction, especially of visceral fat in patients awaiting bariatric surgery (BS), may facilitate the surgical process, and reduce postoperative complications. Normally, to achieve weight reductions a nutritional treatment is prescribed, but the effects of exercise on these patients have been little studied. Objectives: To know the effects of an exercise program on body composition and cardiovascular risk factors in patients awaiting BS. Methods: Twenty-three patients awaiting BS were divided into two groups: a) an experimental group (EG, n = 12); b) a control group (CG, n = 11). Both groups received the usual care prior to surgery, but the EG also performed a 12-week exercise program in which endurance and resistance training were combined. Body composition, anthropometric measures, cardiovascular risk factors, physical fitness, basal metabolic rate and quality of life were assessed at baseline and at the end of the study.

NCT ID: NCT03588273 Completed - Clinical trials for Bariatric Surgery Candidate

Effect of Stomach Reduction Surgery on the Parameters of Amoxicillin

Start date: June 24, 2016
Phase: N/A
Study type: Interventional

The objective of this study was to evaluate the impact of bariatric surgery on the pharmacokinetics of amoxicillin. Methods: This study was performed as a randomized, open-label, single-dose clinical trial, with two periods of treatment, in which obese subjects (n=8) received amoxicillin 500 mg capsule orally before and 2 months after the Roux-en-Y gastric bypass surgery. The amoxicillin plasma concentration was determined by liquid chromatography coupled to mass spectrometry (LC-MS/MS).

NCT ID: NCT03587727 Active, not recruiting - Obesity Clinical Trials

Hepatic Mitochondrial Function in Youth

MANGO
Start date: November 20, 2018
Phase:
Study type: Observational

Assess the impact of bariatric surgery on hepatic energy metabolism and glucose and insulin dynamics in obese youth

NCT ID: NCT03573258 Completed - Clinical trials for Bariatric Surgery Candidate

Dietary Fibers and Satiety in Bariatric Patients

FIBAR
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The primary objective is to evaluate the effect of a viscous and fermentable dietary fibre on ad libitum eating in morbidly obese patients before and 6 month after Roux-en-Y gastric bypass (RYGB) surgery. The secondary objectives are to study the effect of a viscous and fermentable dietary fibre on perceived appetite, the production of short chain fatty acids (SCFA), breath hydrogen (as a marker of large intestinal fermentation), the secretion of gastrointestinal (GI) satiation hormones and glycaemia in morbidly obese patients before and 6 month after RYGB surgery. The primary study outcome measure is macronutrient and food intake (grams and kcal eaten) at the ad libitum buffet meal as well as time to complete the meal. Secondary outcome measures are 1) Appetite ratings (validated visual analogue scales, VAS) including hunger, fullness, thirst, desire to eat, and amount of food desired to eat. 2) Plasma concentrations of SCFA (propionate, acetate, butyrate). 3) Breath hydrogen (as a marker of large intestinal fermentation) 4) Plasma concentrations of gastrointestinal hormones (ghrelin, cholecystokinin (CCK), glucagon-like peptide-1 (GLP-1), peptide YY (PYY) and potentially other, yet to be identified gut hormones). 4) Concentrations of plasma insulin and glucagon and blood glucose. Randomized, single-blinded cross-over trial in 24 morbidly obese human subjects undergoing RYGB (study A, n=12; study B, n=12). Study B also includes an additional pilot study in 6 morbidly obese patients before and 6 month after RYGB surgery. Thus, the total number of subjects including the pilot study is 30.

NCT ID: NCT03563287 Completed - Clinical trials for Bariatric Surgery Candidate

Effects of LRYGB on Pharmacokinetics of Nine CYP Probe Drugs

Start date: January 27, 2012
Phase: N/A
Study type: Interventional

Due to anatomical and physiological changes caused by the Roux-en-Y gastric bypass (RYGB) bariatric surgery, drug bioavailability after the surgery can be altered. Therefore, post-operative dose adjustment in these patients can be required. The aim of the study was to investigate the effects of laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery on drug pharmacokinetics and cytochrome P450 (CYP) mediated metabolism using a cocktail of nine CYP probe drugs. The cocktail covers nine main CYP enzymes: melatonin (CYP1A2), nicotine (CYP2A6), bupropion (CYP2B6), repaglinide (CYP2C8), losartan (CYP2C9), omeprazole (CYP2C19/CYP3A4), dextromethorphan (CYP2D6), chlorzoxazone (CYP2E1), midazolam (CYP3A4). The changes in pharmacokinetic parameters of the drugs as well as modulation of the activity of CYPs are evaluated before and one year after LRYGB. In the study, the patients administering drug cocktail before surgery and 1 year after LRYGB are served as their own controls.

NCT ID: NCT03558360 Recruiting - Clinical trials for Bariatric Surgery Candidate

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

MMS-CB
Start date: October 15, 2018
Phase:
Study type: Observational

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.

NCT ID: NCT03558100 Completed - Obesity Clinical Trials

Reducing Fall Risks for Adults With Obesity

ObesityFalls
Start date: September 1, 2014
Phase: N/A
Study type: Interventional

The objective of the clinical study was to examine if practice could improve walking patterns associated with fall risks before patients with obesity underwent weight loss surgery. We hypothesized that patients would show improvements in their walking after completing the intervention. For the intervention, patients walked under five conditions: on flat ground at the beginning of the study, crossing three obstacle heights, and on flat ground at the end of the study for a total of 25 times.