CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 136 enrolled
Drug / intervention
Bariatric Surgeryprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02148068
NCT02148068N/ACompleted

Roux-en-y Gastric Bypass Versus Sleeve Gastrectomy - Analysis of the Disparate Effects on Body Composition and Associated Comorbidity Resolution

Peter Nau·observational·Posted May 28, 2014·Updated Nov 20, 2018

In Brief

An observational study evaluating Bariatric Surgery for Obesity. Completed, enrolled 136 participants across 1 site.

Detailed Summary

Obesity is an important public health issue worldwide. In the United States, the percentage of overweight and obese adults increased from 47 and 15%, respectively, to 69 and 36% in the last 40 years. Medically supervised attempts at weight loss are fraught with failures and recidivism. Surgical approaches to this important issue are both durable and effective. The gold standard approach to the surgical treatment of obesity and the attendant medical comorbidities is the laparoscopic roux-en-y gastric bypass (RYGB) and the laparoscopic sleeve gastrectomy (LSG). The mechanisms by which these two operations work and the associated side effects are not completely understood. It is established that the RYGB induces changes in both the fatty tissue mass (FTM) and lean body mass (LBM) post-operatively. This is associated with decreases in bone mineral density, basal metabolic rate, and potentially the ability to maintain weight loss. There is only incomplete information on the influence that the LSG has on body composition. This study proposes an evaluation of the changes in body composition that occurs following these two disparate operations. Using serial measurements by the BodPod and collecting information on the patients' dietary intake, exercise habits and comorbidity resolution, this study will help to better define the influence that the LSG has on body composition. It is hypothesized that the addition of a malabsorptive component will result in increased speed weight loss and overall weight loss which will have a negative impact in the preservation of lean tissue mass for the patient. This information can then be used by bariatric surgeons to better cater the surgical procedure and post-operative plan to the patient's body make up and medical comorbidities.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 28, 2014
Enrollment StartMay 1, 2014
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 12.1 years ago

Interventions

Bariatric Surgeryprocedure

Patients enrolled will undergo either a laparoscopic Roux-en-y Gastric Bypass or laparoscopic Sleeve Gastrectomy. The determination of which operation performed will be made independent of patients' enrollment in the study.