RECRUITING

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

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Conditions

Diabetes Mellitus Type 2, Childhood-Onset

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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 goal of the DISCOVERY study is to provide innovative critical information regarding the unique natural history of glycemic control, insulin sensitivity, and β-cell function, and their mechanistic determinates, in obese adolescents at risk for developing type 2 diabetes.

Official Title

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

Quick Facts

Study Start:2024-10-01
Study Completion:2028-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06525259

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:9 Years to 14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Overweight or obesity with BMI ≥85th percentile
  2. * Age 9-13 year for girls, 10-14 year for boys (inclusion younger for girls as puberty tends to start a year earlier in girls)
  3. * Tanner Stage 2 or 3 or Tanner Stage 4 (without initiation of menses for Tanner 4 girls)
  4. * Elevated HbA1c 5.5-6.4%
  5. * Family history of type 2 diabetes in 1st or 2nd degree relative
  6. * Personal exposure to maternal diabetes (i.e., gestational diabetes mellitus (GDM) or mother with type 1 or type 2 diabetes while pregnant with participant)
  7. * HbA1c \>6.0%
  8. * Severe obesity (BMI \>99th percentile)
  9. * Personal history of intrauterine growth restriction (IUGR), small for gestational age (SGA), or low birth weight
  1. * Diabetes based on history, or HbA1c ≥6.5% in the medical record or at screening
  2. * Unable/unwilling to provide consent/participate fully
  3. * Conditions predisposing to diabetes or altering the trajectory of puberty (transplant, cancer, Down Syndrome, Turner Syndrome, Klinefelter Syndrome, ovarian/testicular failure, etc.)
  4. * Medications affecting glucose dynamics during the screening and enrollment period (oral steroids, inhaled steroids \>1,000mcg/day past month, atypical antipsychotics, topiramate)
  5. * Prior treatment with insulin
  6. * Use of glucagon-like peptide-1 (GLP-1) receptor agonist or any weight loss medications in the 6 weeks prior to enrollment
  7. * Planning treatment with glucagon-like peptide-1 (GLP-1) receptor agonist or any weight loss medications
  8. * Use of metformin or any glucose lowering medication for a reason other than treatment of diabetes (e.g., for PCOS) in the 6 weeks prior to enrollment
  9. * Known syndromic/monogenic obesity
  10. * Blood disorders impacting HbA1c (e.g., anemia, hemoglobin variants)
  11. * Major systemic organ disease
  12. * History of bariatric surgery or currently planning bariatric surgery
  13. * Current pregnancy or currently planning pregnancy
  14. * Use of GnRH agonist, estrogen, or testosterone
  15. * Individuals who do not speak English or Spanish, given validation of the questionnaires to be utilized

Contacts and Locations

Study Contact

Barbara Braffett, PhD
CONTACT
3018819260
braffett@bsc.gwu.edu
Brian Burke, MS
CONTACT
3018819260
bburke@bsc.gwu.edu

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Arizona State University
Phoenix, Arizona, 85004
United States
Phoenix Children's
Phoenix, Arizona, 85006
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
United States
Boston Children's/Joslin Diabetes Center/Massachusetts General Hospital
Boston, Massachusetts, 02215
United States
Colorado Navajo Nation
Shiprock, New Mexico, 87420
United States
Albert Einstein College of Medicine
Bronx, New York, 10461
United States
NYU Langone Health- Brooklyn
Brooklyn, New York, 11220
United States
NYU Langone Health- Long Island
Garden City, New York, 11530
United States
NYU Langone Health- Manhattan
New York, New York, 10016
United States
Atrium Health
Charlotte, North Carolina, 28207
United States
Wake Forest University
Winston Salem, North Carolina, 27157
United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Baylor College of Medicine / Texas Children's
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: George Washington University

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 Date2024-10-01
Study Completion Date2028-01-31

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2028-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus Type 2, Childhood-Onset