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Bariatric Surgery Candidate clinical trials

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NCT ID: NCT03683589 Completed - Clinical trials for Bariatric Surgery Candidate

De Novo Lipogenesis in Severity of NAFLD

Start date: February 1, 2019
Phase:
Study type: Observational

NAFLD is the most prevalent liver disease in the U.S., and there is a serious need to understand its progression to the advanced state, nonalcoholic steatohepatitis (NASH). Previous studies has shown that elevated de novo lipogenesis (DNL) is the unique, early event distinguishing patients with NAFLD from equally-obese subjects with low IHTG. The purpose of this study is to directly by measure DNL in human liver tissue and comparing it to liver histological scores from patient biopsies.

NCT ID: NCT03666481 Completed - Morbid Obesity Clinical Trials

Physical Activity in Bariatric Patients

Start date: November 16, 2011
Phase: N/A
Study type: Interventional

The aim of the current study was to explore the effect of a 6-months motivational physical activity intervention (MPAI) on different psychosocial variables (e.g. motivation, health-related quality of life, self-esteem, etc.) and on the physical activity levels of bariatric surgery patients. Comparing with a control group (CG), we tested the differences obtained on these variables between before surgery and just after the MPAI (7-months after surgery). Additionally, we explored the (possible) prolonged effects of the intervention by doing re-tests 13, 25 and 37- months after surgery.

NCT ID: NCT03653962 Completed - Clinical trials for Bariatric Surgery Candidate

Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content

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

This study evaluates the addition of video presentation on conventional informed consent. Participants divided two randomly, one group read only conventional informed consent, the other video presentation was watched after reading conventional consent.

NCT ID: NCT03643783 Completed - Obesity Clinical Trials

Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients

Start date: September 11, 2018
Phase:
Study type: Observational

Obesity increases the risk for type 2 diabetes mellitus, high blood pressure, and mortality. Obesity is a major health problem in the United States, especially in the Deep South regions. Obesity increases the risk for T2DM, the occurrence of hypertension, and mortality; but the efficacy of long-term weight loss medications has been disappointing. There are three options available for patients who want to lose weight: lifestyle modification, pills, or weight loss by bariatric surgery. When we compare the three options available, bariatric surgery is the most effective method to lose weight at present. Bariatric surgery allows patients lose the most weight, be able to sustain the weight reduction over time and, more importantly, diabetes mellitus and other cardiovascular risk factors significantly improve. Understanding the link among obesitydiabetes-hypertension is crucial in order to develop new therapeutic targets to decrease CVD morbidity and mortality. There is less prevalence of coronary artery disease (CAD) in premenopausal women than in men, but, once initiated, the morbidity and mortality due to CAD in women is worse than in men, thus highlighting this sex difference in CVD. Indeed, women with diabetes exhibit a higher risk of myocardial infarction and stroke mortality than men, compared to people without diabetes. In obese subjects, there is inappropriate activation of the systemic and adipose renin-angiotensin system. The prorenin receptor is a molecule expressed in various tissues including fat tissue and part of it, the soluble prorenin receptor, can be secreted into the blood. The prorenin receptor is part of a very important system that regulates blood pressure and fat in our body, the renin-angiotensin system. In this prospective observational human pilot study, we will determine whether the adipose tissue is the major supplier of soluble prorenin receptor levels in the plasma of obese patients and the relationship between blood soluble prorenin receptor and diabetes mellitus, obesity, high blood pressure and other important cardiovascular risk factors. Outcomes from this study will allow a better understanding of the complex factors that link obesity, diabetes mellitus, and other cardiovascular risk factors and designing better therapeutic alternatives to improve patient's health, particularly in obese diabetic women.

NCT ID: NCT03642197 Completed - Physical Activity Clinical Trials

Feasibility and Preliminary Efficacy of Support Figure Attendance at Bariatric Patients' Clinical Visits

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

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy for the inclusion of support figures and romantic partners throughout the bariatric surgery process, from pre-surgery to two months post-surgery. This will be done using a four-arm randomized controlled trial (RCT). Using simple randomization, female patients in romantic relationships will be randomized into partner attended (PA) groups and treatment as usual (PA-TU) groups; patients (female or male) not in romantic relationships will be randomized into support figure attended (SFA) and SFA-TU groups. The goals of this study are to provide preliminary evidence for including support figures/partners in patients' routine BS healthcare visits, including the subsequent impact on post-surgery patient and support figure/partner behavior change and weight loss, relationship outcomes, and exploration of barriers to support figure/partner involvement. Aim 1: To assess the feasibility and acceptability of support figure/partner involvement for BS patients. Feasibility will be assessed throughout the study by attendance at the four pre-surgery classes and the clinic visit assessment time points. Perceived fiscal and time involved in the study will be assessed. Acceptability will be assessed from patient and support figure/partner interviews regarding the barriers and benefits to attendance, and alternative mediums to engage support figures/partners. Aim 2: To evaluate the effect of support figure/partner attendance (SFA, PA arms) on patient weight loss, behavior change, and relationship outcomes from T1-T4. Estimates of effect size and variance in patient weight loss and behavior change will be collected from T1-T4 for comparison of the SFA/PA and SFA-TU/PA-TU arms.

NCT ID: NCT03641417 Completed - Obesity Clinical Trials

Investigating the Role of Ghrelin in Regulating Appetite and Energy Intake in Patients Following Bariatric Surgery (BARI-INSIGHT)

BARI-INSIGHT
Start date: February 15, 2019
Phase: N/A
Study type: Interventional

Bariatric surgery helps patients with severe obesity to lose weight, cures and prevents diseases linked to obesity and reduces the risk of death. Unfortunately, 1 in 5 patients do not respond well to surgery in terms of weight loss and health gains. Thus, maximising weight loss and health benefits after surgery is critical. This study aims to gain insight into the role that the appetite-stimulating hormone, ghrelin, plays in driving appetite and energy intake in patients with poor weight loss (≤ 20% total body weight) following bariatric surgery. This will guide future work to develop pharmacological treatments for obesity, both as standalone treatments and adjuncts to bariatric surgery. Participants will be invited to attend the Clinical Research Facility at University College London Hospital for a screening visit and six study visits. Active ghrelin levels will be reduced by inhibiting ghrelin-o-acyl-transferase (GOAT), the enzyme needed to generate active ghrelin (acyl ghrelin, AG). Participants will be randomised to receive GLWL-01 (GOAT inhibitor) 300mg BD or placebo for a 10 day study cycle. The effect of AG reduction on appetite and energy intake will be evaluated through both fixed-energy and ad libitum meal tests on day 7 and 10, respectively. Measures of body weight and composition, appetite and food cravings will be performed in addition to biochemical profiling of circulating gut hormone, adipokine and cytokine levels. Targeted physical examinations and assessment of adverse events will be performed. Safety monitoring calls will be conducted 2 and 7 days after the last dose. Following a 6-10 week washout period, participants will cross over to receive either placebo or GLWL-01 300mg BD and undergo a second study cycle, with all measures repeated.

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: 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: 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.