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

NCT ID: NCT03091725

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-25
• Study Completion Date: 2026-07-31

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.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Roux-en-Y gastric bypass surgery

Intervention Type: PROCEDURE

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

LCD Group

Subjects in this group will participate in a low-calorie diet intervention to achieve \~16-18% weight loss.

Group Type: ACTIVE_COMPARATOR

Low-calorie diet

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: PROCEDURE

Low-calorie diet

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kilo Diabetes & Vascular Research Foundation

UNKNOWN

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Beth Henk

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Beth Henk

Role: CONTACT

bhenk@wustl.edu

314-362-8250

Facility Contacts

Beth Henk

Role: primary

bhenk@wustl.edu

314-362-8250

Other Identifiers

201612107

Identifier Type: -

Identifier Source: org_study_id