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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03467906
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
44
1
35.2
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: In-laboratory assessment

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 Design

Study Type:
Observational
Anticipated Enrollment :
44 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Role of Dietary Habits in Efficacy of Bariatric Surgery - Study B
Actual Study Start Date :
May 25, 2021
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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
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.

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
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.

Outcome Measures

Primary Outcome Measures

  1. Self-rated hunger [One day of laboratory protocol]

    Hunger measured from the visual analogue scale (VAS) questionnaire

Secondary Outcome Measures

  1. Self-rated appetite [One day of laboratory protocol]

    Appetite measured from the visual analogue scale (VAS) questionnaire

  2. Appetite-regulating hormones [One day of laboratory protocol]

    Appetite-regulating hormones from blood samples

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 62 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Brigham and Women's Hospital
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Frank Scheer, PhD, Brigham and Women's Hospital
  • Principal Investigator: Ali Tavakkoli, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Frank AJL Scheer, PhD, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT03467906
Other Study ID Numbers:
  • 2017P002526B
  • R01HL140574
First Posted:
Mar 16, 2018
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Frank AJL Scheer, PhD, Professor of Medicine, Brigham and Women's Hospital

Study Results

No Results Posted as of Apr 14, 2022