DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Diabetes Mellitus Type 2, Childhood-Onset
- 发起方
- George Washington University
- 入组人数
- 3600
- 试验地点
- 20
- 主要终点
- Type 2 diabetes
- 状态
- 招募中
- 最后更新
- 12天前
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.
研究者
Barbara Braffett
Associate Professor
George Washington University
入排标准
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)
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)