RECRUITING

Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance

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

This 12-week controlled diet and weight intervention study seeks to define the molecular pathways that link excess body weight to the development of insulin resistance (IR). Blood, adipose and stool are sampled at three timepoints; baseline, peak weight (4 weeks) and post weight loss to monitor changes in cellular processes. Additionally, direct insulin sensitivity testing, and radiological measurement of visceral fat and intrahepatic fat content is measured at three timepoints to correlate clinical indices with cellular changes.

Official Title

Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance

Quick Facts

Study Start:2019-01-31
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05165706

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:35 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 35-65
  2. * BMI 25-35 kg/m2
  3. * Stable body weight
  4. * Nondiabetic
  1. * diabetes
  2. * major organ disease
  3. * history of liposuction or bariatric surgery
  4. * active eating or psychiatric disorder
  5. * pregnancy or lactation, heavy alcohol use
  6. * recent change in weight (over the past 12 weeks)
  7. * use of weight loss medication, statins, or oral steroids
  8. * hematocrit \< 33%
  9. * fasting glucose \>/= 126 mg/dL
  10. * blood pressure \>160/100 mmHg

Contacts and Locations

Study Contact

Ekrem M Ayhan, BS
CONTACT
908-619-5381
ayhane@stanford.edu
Dalia Perelman, MS, RD
CONTACT
daliap@stanford.edu

Principal Investigator

Tracey McLaughlin, MD
PRINCIPAL_INVESTIGATOR
Stanford University, Department of Medicine, Division of Endocrinology

Study Locations (Sites)

Stanford University
Stanford, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Tracey McLaughlin, MD, PRINCIPAL_INVESTIGATOR, Stanford University, Department of Medicine, Division of Endocrinology

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 Date2019-01-31
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2019-01-31
Study Completion Date2026-12-30

Terms related to this study

Keywords Provided by Researchers

  • Metabolomics
  • Low Fat Diet
  • Low Carbohydrate Diet
  • Microbiome

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2
  • PreDiabetes
  • Insulin Resistance
  • Obesity
  • Nonalcoholic Steatohepatitis
  • Nonalcoholic Fatty Liver
  • Diet Modification