RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-04-25
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03091725

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and Females
  2. * Scheduled for RYGB surgery
  3. * Body Mass Index 35-60 kg/m²
  4. * Without Type 2 Diabetes (T2D)
  5. * Males and Females
  6. * Body Mass Index 35-60 kg/m²
  7. * Without Type 2 Diabetes (T2D)
  1. * Regular use of tobacco products
  2. * Previous intestinal resection
  3. * Pregnant or breastfeeding
  4. * Evidence of significant organ system dysfunction or disease other than obesity and T2D
  5. * Use of any medication that might, in the opinion of the investigator, affect metabolic function
  6. * Exercise ≥90 minutes per week
  7. * Use or past use of hormone replacement therapy within the past 6 months

Contacts and Locations

Study Contact

Beth Henk
CONTACT
314-362-8250
bhenk@wustl.edu

Principal Investigator

Samuel Klein, MD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Beth Henk
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Samuel Klein, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-04-25
Study Completion Date2026-07

Study Record Updates

Study Start Date2017-04-25
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • Obesity
  • Roux-en-Y gastric bypass (RYGB)
  • Low calorie diet

Additional Relevant MeSH Terms

  • Obesity