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

NCT03091725 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-17

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Kilo Diabetes & Vascular Research Foundation

    collaborator UNKNOWN

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Samuel Klein, MD · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-25
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03091725 on ClinicalTrials.gov