Diabetes Mellitus Type 2, Childhood-Onset
Conditions
Brief summary
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.
Detailed description
The DISCOVERY study will extensively phenotype a large cohort of youth at-risk for type 2 diabetes, as they transition through puberty, and characterize the course of dysfunction in pathophysiological indicators that lead to type 2 diabetes. The knowledge gained from this study of the pathophysiology and epidemiology of youth-onset type 2 diabetes with deep biochemical, clinical, and psychosocial phenotyping will critically inform the design and testing of future treatment and prevention approaches.
Interventions
None listed
Sponsors
George Washington University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 15 Years
Inclusion criteria
Screening will occur to enrich the yield of individuals who are highly predisposed to develop youth-onset T2D and include those with all of the following criteria: * Overweight or obesity with BMI ≥85th percentile * Age 8-13 year for girls, 9-15 year for boys (inclusion younger for girls as puberty tends to start a year earlier in girls) * Tanner Stage 2, 3, or 4 * Elevated HbA1c 5.5-6.4%
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation: * 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 * Medications affecting glucose dynamics during the screening and enrollment period * 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 * Planning treatment with metformin or any glucose lowering medication or planning to use such medications for a reason other than treatment of diabetes (e.g., for PCOS) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type 2 diabetes | Through study completion, an average of 2.5 years | Development of type 2 diabetes, as defined by a hemoglobin A1c (HbA1c) ≥6.5% at an annual or mid-year visit followed by a confirmatory HbA1c ≥6.5% collected within 2 weeks of the first value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemia, β-cell function, insulin sensitivity, and free fatty acid flux | Through study completion, an average of 2.5 years | Intermediary changes in glycemia, β-cell function, insulin sensitivity, and free fatty acid flux along the spectrum of normal glycemia to prediabetes to type 2 diabetes. |
Countries
United States
Contacts
CONTACTBarbara Braffett, PhD
CONTACTBrian Burke, MS
Outcome results
None listed