Role of Dietary Habits in Efficacy of Bariatric Surgery - Study B
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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
- Self-rated hunger [One day of laboratory protocol]
Hunger measured from the visual analogue scale (VAS) questionnaire
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Bariatric surgery (sleeve gastrectomy) patients
Exclusion Criteria:
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Insulin-dependent diabetes
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Anemia
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Smoking
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Shift work within the past 1 year
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Drug or alcohol dependency
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Bipolar disorder
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Post traumatic stress disorder (PTSD)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- 2017P002526B
- R01HL140574