Skip to main content
Clinical Trials/NCT03467906
NCT03467906
Active, not recruiting
Not Applicable

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

Brigham and Women's Hospital1 site in 1 country44 target enrollmentMay 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bariatric Surgery
Sponsor
Brigham and Women's Hospital
Enrollment
44
Locations
1
Primary Endpoint
Self-rated hunger
Status
Active, not recruiting
Last Updated
4 months ago

Overview

Brief Summary

The purpose of the study is to compare dietary habits after bariatric surgery in patients with poor weight loss versus good weight loss outcomes.

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 the study is to compare dietary habits after bariatric surgery in patients with different weight loss outcomes.

Registry
clinicaltrials.gov
Start Date
May 25, 2021
End Date
June 30, 2028
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

  • Insulin-dependent diabetes
  • Shift work within the past 1 year
  • Drug or alcohol dependency
  • Bipolar disorder
  • Post traumatic stress disorder (PTSD)

Outcomes

Primary Outcomes

Self-rated hunger

Time Frame: One day of laboratory protocol

Hunger measured from the visual analogue scale (VAS) questionnaire

Secondary Outcomes

  • Self-rated appetite(One day of laboratory protocol)
  • Appetite-regulating hormones(One day of laboratory protocol)

Study Sites (1)

Loading locations...

Similar Trials