TODAY Genetics Study

Study Overview
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Brief Summary
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The TODAY study group has prepared a protocol with the primary objective of collecting blood and phenotypic information to be used to explore relationships between candidate genes and type 2 diabetes (T2D), as well as obesity, insulin resistance, and cardiovascular complications of insulin resistance. Participation in the genetics study includes a blood draw for analysis of diabetes type and DNA extraction, as well as collection of basic family and medical history. Appropriate informed consent and assent are obtained from all participants to extract DNA and send blood, genetic material, and medical history to the Central Repository of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The data are kept indefinitely by the Central Repository. The NIDDK will issue requests for proposals (RFP) throughout the scientific community for research that may help in the development of new diagnostic tests, new treatments, and new ways to prevent diabetes and other related comorbidities.

Official Title
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Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Genetics Study

Conditions
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Type 2 Diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes by ADA criteria (laboratory determinations of fasting glucose ≥ 126 mg/dL, random glucose ≥ 200 mg/dL, or two-hour oral glucose tolerance test (OGTT) glucose ≥ 200 mg/dL) documented and confirmed in medical record or a laboratory determination of HbA1c ≥ 7%. For asymptomatic patients diagnosed with diabetes with a normal fasting glucose but an elevated two-hour glucose during an OGTT, the HbA1c must be ≥ 6%. BMI ≥ 85th percentile documented at time of diagnosis or at screening. Age < 18 at time of diagnosis. Signed informed consent and assent forms as appropriate. Exclusion Criteria: Genetic syndrome or disorder known to affect glucose tolerance other than diabetes. Patient on medication known to affect glucose tolerance, insulin sensitivity or secretion within 60 days of the time of diagnosis. If diagnosis is confirmed after the patient has been off the medication for 60 days, the patient may be included. Exclusionary medications include but are not limited to inhaled steroids at dose above 1000 mcg daily fluticasone equivalent, oral glucocorticoids, antirejection or chemotherapy agents (e.g., tacrolimus, L-asparaginase), atypical antipsychotics.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood draw to be processed and analyzed to yield genetic data. | Blood is sent to the DNA processing center identified by NIDDK for processing and shipment to the NIDDK Repository. | Blood is drawn at the single study visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotype data. | Demographic, medical history, and other data about participant and family, by self-report. | Collected at single study visit. | 
| Laboratory values. | Serum glucose, C-peptide, and pancreatic autoimmunity antibodies determined by study central laboratory. | Single study visit. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genetics, pediatrics