Comparing metabolic responses to meals before and after weight loss in obese adults
Postprandial Nutrient Homeostasis Before and After Weight Loss Induced by Low-calorie Diet or RYGB
This study is testing how different types of meals affect metabolism in obese adults before and after they lose weight through surgery or a diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT03091725 on ClinicalTrials.gov |
What this trial studies
This study aims to compare how low-carbohydrate and standard-carbohydrate meals affect metabolic responses in African American and non-Hispanic White adults with obesity. Participants will undergo either Roux-en-Y gastric bypass surgery or a low-calorie diet to induce weight loss, followed by assessments of insulin and glucose kinetics, hormone levels, and other metabolic factors after consuming both types of meals. The study will evaluate these responses before and after a weight loss of approximately 16-18%. The goal is to understand the impact of weight loss on nutrient homeostasis in this population.
Who should consider this trial
Good fit: Ideal candidates are adults with a Body Mass Index (BMI) of 35-60 kg/m² who do not have Type 2 Diabetes.
Not a fit: Patients with significant organ dysfunction, those who exercise regularly, or those using certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary recommendations and treatment strategies for obesity management.
How similar studies have performed: Other studies have shown promising results in understanding metabolic responses to dietary changes in obese populations, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Surgery Group (RYGB): * Males and Females * Scheduled for RYGB surgery * Body Mass Index 35-60 kg/m² * Without Type 2 Diabetes (T2D) LCD group: * Males and Females * Body Mass Index 35-60 kg/m² * Without Type 2 Diabetes (T2D) Exclusion Criteria: * Regular use of tobacco products * Previous intestinal resection * Pregnant or breastfeeding * Evidence of significant organ system dysfunction or disease other than obesity and T2D * Use of any medication that might, in the opinion of the investigator, affect metabolic function * Exercise ≥90 minutes per week * Use or past use of hormone replacement therapy within the past 6 months
Where this trial is running
Saint Louis, Missouri
- Beth Henk — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Samuel Klein, MD — Washington University School of Medicine
- Study coordinator: Beth Henk
- Email: bhenk@wustl.edu
- Phone: 314-362-8250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.