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

Active, not recruiting

• Conditions: Bariatric Surgery; Sleeve Gastrectomy; Obesity
• Interventions: Other: In-laboratory assessment

• Registration Number: NCT03467906
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-16
• Study Start: 2021-05-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Bariatric surgery (sleeve gastrectomy) patients

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Weight loss > median of group	In-laboratory assessment	Sleeve gastrectomy surgery patients will take part in in-laboratory assessment. Based on 1-year post-surgical weight loss, a median split will be done to allocate subjects to one of two groups.
Weight loss < median of group	In-laboratory assessment	Sleeve gastrectomy surgery patients will take part in in-laboratory assessment. Based on 1-year post-surgical weight loss, a median split will be done to allocate subjects to one of two groups.

Primary Outcome Measures

Name	Time	Method
Self-rated hunger	One day of laboratory protocol	Hunger measured from the visual analogue scale (VAS) questionnaire

Secondary Outcome Measures

Name	Time	Method
Self-rated appetite	One day of laboratory protocol	Appetite measured from the visual analogue scale (VAS) questionnaire
Appetite-regulating hormones	One day of laboratory protocol	Appetite-regulating hormones from blood samples

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States