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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03482986
• Other study ID #: 2017P002526C
• Secondary ID: R01HL140574
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2021
• Est. completion date: May 2024

Study information

• Verified date: August 2022
• Source: Brigham and Women's Hospital
• Contact: Ioanna Tegos
• Phone: 617-278-0051
• Email: itegos[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.

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 test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 62 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity
• Sleeve Gastrectomy

Intervention

Behavioral:
• Dietary habits plan
Patients will be given a personalized plan regarding their diet.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-intervention change in self-rated hunger	Differences in self-rated hunger as measured from the visual analogue scale (VAS; 0-100 score with 0 as ''not at all'' and 100 as ''very much''/''extremely'') questionnaire at baseline and after the intervention	Baseline and 4 weeks (post-intervention)
Secondary	Change in caloric intake	Difference in caloric intake from baseline to post-intervention	baseline and 4 weeks (post-intervention)
Secondary	Change in energy expenditure	resting and postprandial energy expenditure measured by indirect calorimetry	baseline and 4 weeks (post-intervention)
Secondary	Change in glucose tolerance	Glucose response to mixed meal test	baseline and 4 weeks (post-intervention)