Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Genetics Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,654
- 试验地点
- 25
- 主要终点
- Blood draw to be processed and analyzed to yield genetic data.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Blood draw to be processed and analyzed to yield genetic data.
时间窗: Blood is drawn at the single study visit.
Blood is sent to the DNA processing center identified by NIDDK for processing and shipment to the NIDDK Repository.
次要结局
- Phenotype data.(Collected at single study visit.)
- Laboratory values.(Single study visit.)