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

NCT03467906 | Active Not Recruiting DMC

• 2 other identifiers: 2017P002526BR01HL140574
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleeve Gastrectomy; Bariatric Surgery; Obesity

Keywords

Diet; Dietary Habits; Weight changes

Outcome Measures

Primary Outcomes (1)

• Self-rated hunger

  Hunger measured from the visual analogue scale (VAS) questionnaire

  One day of laboratory protocol

Secondary Outcomes (2)

• Self-rated appetite

  One day of laboratory protocol

• Appetite-regulating hormones

  One day of laboratory protocol

Study Arms (2)

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

In-laboratory assessment OTHER

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; Weight loss > median of group

Eligibility Criteria

• Age: 22 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients that have undergone sleeve gastrectomy surgery.

You may qualify if:

• Bariatric surgery (sleeve gastrectomy) patients

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, urine, saliva.

MeSH Terms

Conditions

Obesity; Feeding Behavior; Body Weight Changes

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Frank Scheer, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Ali Tavakkoli, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 16, 2018
• Study Start: May 25, 2021
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)