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Active Not Recruiting
NCT03091725
Postprandial Nutrient Homeostasis Before and After Weight Loss Induced by Low-calorie Diet or RYGB
Conditions: Obesity
Sex: All
Ages: 25 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: Washington University School of Medicine
Location: Beth Henk St Louis Missouri
Summary
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT03091725). StuddyBuddy aggregates publicly available trial information.