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Bariatric Surgery clinical trials

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NCT ID: NCT04049786 Enrolling by invitation - Obesity Clinical Trials

Impact of Bariatric Surgery on Pharmacokinetic Study of Simvastatin and Carvedilol

Start date: June 1, 2019
Phase: Phase 4
Study type: Interventional

Obesity affects more than 1 in 3 adults in the U.S. It is commonly associated with reduced quality of life and complications such as metabolic syndrome, heart disease, high blood pressure and sleep disorders. The gastric bypass, also known as Roux-en-Y gastric bypass (RYGB), is one of the most common weight-loss surgeries due to the reliable and long-lasting weight loss and the effective remission of obesity-associated conditions. Although the impact of obesity on absorption, distribution, metabolism and excretion has been documented for several drugs, label recommendations might not account for specific population subgroups, specially morbidly obese patients and obese patients post-bariatric surgery. This study aims to investigate the impact of obesity and RYGB surgery on the kinetic disposition of simvastatin (Study A) and carvedilol (Study B).

NCT ID: NCT04040647 Completed - Bariatric Surgery Clinical Trials

Tolerance of Early Postoperative Mobilization and Ambulation

MOBTOL
Start date: September 15, 2019
Phase:
Study type: Observational [Patient Registry]

Enhanced recovery programme (ERP) includes early postoperative mobilization and ambulation the day of surgery. Data suggest that orthostatic symptoms prevent a large number of patients from ambulating the day of surgery. The investigators plan to include 50 patients scheduled for colorectal surgery and bariatric surgery in an ERP. A 6-min walk test (6MWT) will be performed before surgery, 3 hour after the end of surgery, and 24 hour after surgery. The day of surgery a 2-min walk test will be realized.

NCT ID: NCT03983135 Completed - Bariatric Surgery Clinical Trials

Revisional Bariatric Surgery Experience

Start date: March 1, 2012
Phase: N/A
Study type: Interventional

The aim of this study is to assess the indications for revisional bariatric surgery and short-term revisional surgical outcomes such as weight loss, BMI variation, % excessive weight loss and % excessive BMI loss .Prospectively-collected patient data will retrospectively reviewed. Patient demographics, body mass index (BMI), primary and revision surgery types, indications of revision, outcomes of revisional surgery and follow-up data for comorbidities will investigated.

NCT ID: NCT03975478 Active, not recruiting - Bariatric Surgery Clinical Trials

Bariatric Surgery and LDL Cholesterol

BASALTO
Start date: July 23, 2019
Phase: N/A
Study type: Interventional

Background: Observational studies have shown that gastric bypass is superior to sleeve gastrectomy in terms of LDL cholesterol improvement. If these results are confirmed in randomized controlled trials, pre-surgical LDL cholesterol status should be a point to consider in the surgical procedure election. Objective: The primary objective is to compare 1-year LDL cholesterol remission after gastric bypass and sleeve gastrectomy in morbid obese patients. Methods: Phase 3, uni-centric, randomized clinical trial, with intention-to-treat analysis to compare LDL cholesterol remission between gastric bypass and sleeve gastrectomy with a 12 months follow-up. The inclusion criteria will be patients aged between 18-60 years old with a body mass index ≥40 or ≥35 kg/m2 with a significant obesity related comorbidity and high LDL cholesterol levels. Patients will be evaluated preoperatively (2 months before surgery) and at 3, 6 and 12 months after bariatric surgery. Examinations will include routine blood chemistry, anthropometric measures, food intake recall, physical activity questionnaires,intima media thickness, fecal samples for microbiota examinations, fat tissue samples and serum samples for lipidomics and hormonal analyses.

NCT ID: NCT03975244 Not yet recruiting - Exercise Clinical Trials

Semi-supervised Exercise Program Before Bariatric Surgery

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Background: Patients awaiting bariatric surgery, apart from suffering higher BMI, show a large number of comorbidities and a low physical fitness. These factors are associated with a longer surgery time, a longer hospital stay and a greater number of operative complications. To reduce these disadvantages, a nutritional intervention is performed to reduce total weight and the comorbidities associated with obesity prior to surgery. However, the prescription of an exercise program, which can be an effective tool to improve these factors, is not usually part of the usual care of these patients. Objective: To know the effects of a semi-supervised exercise program on body composition, cardiovascular risk factors and operative complications in bariatric patients. Methods: Approximately 3 months before surgery, 60 patients awaiting bariatric surgery will be recruited. Patients will be randomized into two groups: a) an experimental group (n = 30); b) a control group (n = 30). The experimental group will perform a semi-supervised exercise program, while the control group will only perform the corresponding evaluations. Both groups will be assessed for body composition, cardiovascular risk factors, physical condition, quality of life and physical activity levels at the beginning and at the end of the intervention. In addition, surgery time, hospital length of stay and operative complications will be evaluated in both groups.

NCT ID: NCT03963986 Recruiting - Bariatric Surgery Clinical Trials

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

STIMUL
Start date: November 28, 2018
Phase: N/A
Study type: Interventional

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

NCT ID: NCT03950245 Completed - Bariatric Surgery Clinical Trials

Incretin Hormone Antagonism After Bariatric Surgery

INCA-BAR
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03905070 Recruiting - Bariatric Surgery Clinical Trials

Investigation of Body Awareness and Affecting Factors in Bariatric Surgery Patients

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

The aim of this study is to investigate the body awareness and the factors affecting the bariatric surgery.

NCT ID: NCT03900481 Not yet recruiting - Morbid Obesity Clinical Trials

Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obesity, or Class II Obesity Without Comorbidity

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The primary objective is to measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)>25%. The secondary objectives are to measure total body weight loss >5%, BMI reduction, tolerance, complications related to this technique in this indication. This study is a prospective, pilot, bi-center safety and efficacy study. 30 patients will be enrolled between APHM, Marseille et CHU L'Archet Nice

NCT ID: NCT03849729 Completed - Obesity Clinical Trials

Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

Start date: March 1, 2018
Phase: Phase 4
Study type: Interventional

Surgical management of Morbid Obesity is increasingly frequent. A low-calorie diet is recommended with the main goal of reducing intrahepatic fat infiltration, fat tissue and making easier the surgery. Information the use pharmacological interventions during the preoperative period in this population are rare.