Clinical trial

Postprandial Nutrient Homeostasis Before and After Weight Loss Induced by Low-calorie Diet or RYGB

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT03091725

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionObesity

Full registry 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

Treatments and study arms

Roux-en-Y gastric bypass surgery

Procedure

Roux-en-Y gastric bypass surgery will be performed with post-weight loss testing performed after \~16-18% weight loss is achieved.

Low-calorie diet

Behavioral

Subjects will meet with a dietitian and/or behaviorist over 4-6 months to lose \~16-18% of their body weight.

Primary outcomes

Postprandial plasma insulin kineticsBaseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity)

Plasma insulin kinetics will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal.

Postprandial plasma insulin kineticsAfter 16-18% weight loss induced by LCD or RYGB (~4-6 months)

Plasma insulin kinetics will be assessed in blood samples collected before and after consuming a standard-carbohydrate or a low-carbohydrate meal.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Beth Henk🇺🇸 St Louis, Missouri, United States

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