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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

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

ArmDescriptionAssigned 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
  • Procedure: Roux-en-Y gastric bypass surgery
    Roux-en-Y gastric bypass surgery will be performed with post-weight loss testing performed after ~16-18% weight loss is achieved.
Active Comparator
LCD Group 		Subjects in this group will participate in a low-calorie diet intervention to achieve ~16-18% weight loss.
  • Behavioral: Low-calorie diet
    Subjects will meet with a dietitian and/or behaviorist over 4-6 months to lose ~16-18% of their body weight.

Recruiting Locations

Washington University in St. Louis and nearby locations

Beth Henk
St Louis, Missouri 63110
Contact:
Beth Henk
314-362-8250
bhenk@wustl.edu

More Details

NCT ID
NCT03091725
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Beth Henk
314-362-8250
bhenk@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.