No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
8 – 15
Sex
Any
Study type
Observational
Participants needed
3,600 (estimated)
Sponsor
George Washington University · Other
Who this trial is looking for
This trial is looking for overweight young people aged 8-15 who may be at risk for developing type 2 diabetes. Participants will help researchers understand how blood sugar control and insulin work in their bodies.
Are You a Good Fit for This Trial?
Must not be takingInsulinGLP-1 receptor agonistsWeight loss medicationsMetformin
Rules you outSyndromic obesityBlood disorders impacting HbA1c
You may be able to join if
I am overweight or obese.
I am a girl aged 8-13 or a boy aged 9-15.
I am at Tanner Stage 2, 3, or 4.
My HbA1c level is between 5.5 and 6.4%.
You may not be able to join if
I have been diagnosed with diabetes.
I am unable or unwilling to participate fully.
I take medications that affect blood sugar.
I have had bariatric surgery or I am planning to have it.
I am currently pregnant or planning to become pregnant.
I have a major systemic organ disease.
I do not speak English or Spanish.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
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…
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
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