Postprandial Nutrient Homeostasis Before and After Weight Loss Induced by Low-calorie Diet or RYGB
Purpose
The purpose of this study is to compare the metabolic responses to low-carbohydrate and standard-carbohydrate meals in African Americans and non-Hispanic White adults with obesity and the effect of weight loss induced by low-calorie diet (LCD) or Roux-en-Y gastric bypass (RYGB) on the metabolic responses to low-carbohydrate and standard meals. Participants will consume: 1) a standard-carbohydrate meal (~49 g glucose) and 2) a low-carbohydrate (~3.4 g glucose) meal on separate study visits performed in a randomized order. We will evaluate the meals' effect before and after ~16-18% weight loss on postprandial i) insulin kinetics, ii) glucose kinetics iii) β-cell function; iv) plasma triglyceride and non-esterified fatty acid concentrations; v) plasma hormone concentrations; vi) plasma cytokine concentrations; vi) plasma metabolomics; and vii) adipose tissue transcriptomics.
Condition
- Obesity
Eligibility
- Eligible Ages
- Between 25 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental RYGB group |
Subjects in this group are scheduled to undergo Roux-en-Y gastric bypass surgery and will be assessed after ~16-18% weight-loss |
|
|
Active Comparator LCD Group |
Subjects in this group will participate in a low-calorie diet intervention to achieve ~16-18% weight loss. |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
More Details
- NCT ID
- NCT03091725
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine