DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

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.

Conditions

Diabetes Mellitus Type 2, Childhood-Onset

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Study Overview

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Study Details

Study overview

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.

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

Condition
Diabetes Mellitus Type 2, Childhood-Onset
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Phoenix

Arizona State University, Phoenix, Arizona, United States, 85004

Phoenix

Phoenix Children's, Phoenix, Arizona, United States, 85006

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

St. Petersburg

Johns Hopkins All Children's Hospital, St. Petersburg, Florida, United States, 33701

Baltimore

Johns Hopkins University School of Medicine, Baltimore, Maryland, United States, 21287

Boston

Boston Children's/Joslin Diabetes Center/Massachusetts General Hospital, Boston, Massachusetts, United States, 02215

Shiprock

Colorado Navajo Nation, Shiprock, New Mexico, United States, 87420

Bronx

Albert Einstein College of Medicine, Bronx, New York, United States, 10461

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Overweight or obesity with BMI ≥85th percentile
  • * 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)
  • * Tanner Stage 2 or 3 or Tanner Stage 4 (without initiation of menses for Tanner 4 girls)
  • * Elevated HbA1c 5.5-6.4%
  • * Family history of type 2 diabetes in 1st or 2nd degree relative
  • * Personal exposure to maternal diabetes (i.e., gestational diabetes mellitus (GDM) or mother with type 1 or type 2 diabetes while pregnant with participant)
  • * HbA1c \>6.0%
  • * Severe obesity (BMI \>99th percentile)
  • * Personal history of intrauterine growth restriction (IUGR), small for gestational age (SGA), or low birth weight
  • * Diabetes based on history, or HbA1c ≥6.5% in the medical record or at screening
  • * Unable/unwilling to provide consent/participate fully
  • * Conditions predisposing to diabetes or altering the trajectory of puberty (transplant, cancer, Down Syndrome, Turner Syndrome, Klinefelter Syndrome, ovarian/testicular failure, etc.)
  • * Medications affecting glucose dynamics during the screening and enrollment period (oral steroids, inhaled steroids \>1,000mcg/day past month, atypical antipsychotics, topiramate)
  • * Prior treatment with insulin
  • * Use of glucagon-like peptide-1 (GLP-1) receptor agonist or any weight loss medications in the 6 weeks prior to enrollment
  • * Planning treatment with glucagon-like peptide-1 (GLP-1) receptor agonist or any weight loss medications
  • * 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
  • * Known syndromic/monogenic obesity
  • * Blood disorders impacting HbA1c (e.g., anemia, hemoglobin variants)
  • * Major systemic organ disease
  • * History of bariatric surgery or currently planning bariatric surgery
  • * Current pregnancy or currently planning pregnancy
  • * Use of GnRH agonist, estrogen, or testosterone
  • * Individuals who do not speak English or Spanish, given validation of the questionnaires to be utilized

Ages Eligible for Study

9 Years to 14 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

George Washington University,

Study Record Dates

2028-01-31