DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-15
SponsorGeorge Washington University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
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
Trial population
3,600 youth, aged 8-15 years at enrollment, of all genders and race/ethnic groups from 15 clinical centers in the United States will be included. Youth will be overweight or obese (BMI ≥85th percentile for age) and have evidence of dysglycemia with an HbA1c range from 5.5-6.4% at screening.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Type 2 diabetes
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.
Time frame
Through study completion, an average of 2.5 yearsSecondary outcomes
1
Glycemia, β-cell function, insulin sensitivity, and free fatty acid flux
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.
Time frame
Through study completion, an average of 2.5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov