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Active, not recruitingNCT03467906Updated Dec 4, 2025

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

An observational study in Bariatric Surgery, Sleeve Gastrectomy and Obesity, sponsored by Brigham and Women's Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 22 Years to 62 Years. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Brigham and Women's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
44
Ages
22 Years to 62 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bariatric Surgery
  • Sleeve Gastrectomy
  • Obesity

Keywords

  • Diet
  • Dietary Habits
  • Weight changes
03

Who can participate

Ages eligible
22 Years to 62 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients that have undergone sleeve gastrectomy surgery.

Inclusion criteria

  • Bariatric surgery (sleeve gastrectomy) patients

Exclusion criteria

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)
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
44 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Weight loss < median of group

    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.

    Other: In-laboratory assessment

  • Weight loss > median of group

    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.

    Other: In-laboratory assessment

Interventions

  • OtherIn-laboratory assessment

    Participants will stay in the laboratory for two days and one night during which they will complete questionnaires, have blood drawn, and have other measurements taken.

05

What researchers measure

Primary outcomes

  1. Self-rated hunger

    Hunger measured from the visual analogue scale (VAS) questionnaire

    Time frame: One day of laboratory protocol

Secondary outcomes

  1. Self-rated appetite

    Appetite measured from the visual analogue scale (VAS) questionnaire

    Time frame: One day of laboratory protocol

  2. Appetite-regulating hormones

    Appetite-regulating hormones from blood samples

    Time frame: One day of laboratory protocol

06

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03467906
Lead sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Frank AJL Scheer, PhD (Professor of Medicine, Brigham and Women's Hospital) — Principal investigator
First posted
Mar 16, 2018
Start date
May 25, 2021
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Dec 4, 2025

Study contacts

Frank Scheer, PhD
principal investigator · Brigham and Women's Hospital
Ali Tavakkoli, MD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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