DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,600
- 试验地点
- 20
- 主要终点
- Type 2 diabetes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
结局指标
主要结局
Type 2 diabetes
时间窗: 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.
次要结局
- Glycemia, β-cell function, insulin sensitivity, and free fatty acid flux(Through study completion, an average of 2.5 years)
研究者
Barbara Braffett
Associate Professor
George Washington University