Clinical trial NCT03091725: Postprandial Nutrient Homeostasis Before and After Weight Loss Induced by Low-calorie Diet or RYGB
Official title: Postprandial Nutrient Homeostasis Before and After Weight Loss Induced by Low-calorie Diet or RYGB
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Obesity
Roux-en-Y gastric bypass (RYGB)
Low calorie diet
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Kilo Diabetes & Vascular Research Foundation
First posted: 2017-03-27
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

Primary outcomes:
measure: Postprandial plasma insulin kinetics
timeFrame: Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity)
measure: Postprandial plasma insulin kinetics
timeFrame: After 16-18% weight loss induced by LCD or RYGB (~4-6 months)
Secondary outcomes:
measure: Postprandial glucose kinetics
timeFrame: Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity)
measure: Postprandial glucose kinetics
timeFrame: After 16-18% weight loss induced by LCD or RYGB (~4-6 months)
measure: β-cell function
timeFrame: Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity)
measure: β-cell function
timeFrame: After 16-18% weight loss induced by LCD or RYGB (~4-6 months)
measure: Postprandial triglyceride concentrations
timeFrame: Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity)
measure: Postprandial triglyceride concentrations
timeFrame: After 16-18% weight loss induced by LCD or RYGB (~4-6 months)
measure: Postprandial non-esterified fatty acid concentrations
timeFrame: Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity)
measure: Postprandial non-esterified fatty acid concentrations
timeFrame: After 16-18% weight loss induced by LCD or RYGB (~4-6 months)
measure: Postprandial hormone concentrations
timeFrame: Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity)
measure: Postprandial hormone concentrations
timeFrame: After 16-18% weight loss induced by LCD or RYGB (~4-6 months)
measure: Postprandial cytokine concentrations
timeFrame: Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity)
measure: Postprandial cytokine concentrations
timeFrame: After 16-18% weight loss induced by LCD or RYGB (~4-6 months)
measure: Postprandial lipids
timeFrame: Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity)
measure: Postprandial lipids
timeFrame: After 16-18% weight loss induced by LCD or RYGB (~4-6 months)
measure: Postprandial metabolites
timeFrame: Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity)
measure: Postprandial metabolites
timeFrame: After 16-18% weight loss induced by LCD or RYGB (~4-6 months)
measure: Transcriptome in adipose tissue
timeFrame: Baseline only (cross-sectional comparison of metabolic responses in African American and non-Hispanic White adults with obesity)
measure: Transcriptome in adipose tissue
timeFrame: After 16-18% weight loss induced by LCD or RYGB (~4-6 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Beth Henk
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Samuel Klein, MD
role: PRINCIPAL_INVESTIGATOR
References: