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Clinical Trials/NCT03470558
NCT03470558
Completed
Not Applicable

Role of Dietary Habits in Efficacy of Bariatric Surgery - Study A

Brigham and Women's Hospital1 site in 1 country290 target enrollmentDecember 6, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bariatric Surgery
Sponsor
Brigham and Women's Hospital
Enrollment
290
Locations
1
Primary Endpoint
Change in BMI at 1-year post-surgical
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

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

Detailed Description

The obesity epidemic is a major public health concern with a significant economic burden in the USA. Bariatric surgery is the most effective and durable weight loss treatment, with long-term cardiometabolic health benefits. Among different types of bariatric procedures, sleeve gastrectomy (SG) has become the most commonly performed in USA. While SG is expected to result in a 50-60% excess weight loss, inter-individual differences in weight loss are large and approximately 25% of patients can be considered poor weight-loss responders who either do not lose a substantial amount of weight or regain the lost weight afterwards. The mechanisms underlying this clinical variation remain unknown and interventions to improve on these outcomes critically lacking. Of interest, altered daily dietary habits are experienced by a substantial proportion of bariatric surgery candidates, raising the question whether such alterations may contribute to inter-individual differences in weight loss success. Therefore, the purpose of this study is to evaluate how dietary habits in the post-surgical year impact outcomes of bariatric surgery.

Registry
clinicaltrials.gov
Start Date
December 6, 2018
End Date
March 1, 2025
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Frank AJL Scheer, PhD

Professor of Medicine

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

  • Bariatric surgery (sleeve gastrectomy) patients

Exclusion Criteria

  • Prior bariatric surgical procedures

Outcomes

Primary Outcomes

Change in BMI at 1-year post-surgical

Time Frame: Baseline and one year

Body mass index at one year after surgery compared to baseline

Study Sites (1)

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