Long-term Post-Intervention Follow-up of the TODAY Cohort (Treatment Options for Type 2 Diabetes in Youth and Adolescents)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 517
- 试验地点
- 15
- 主要终点
- peripheral diabetic neuropathy
研究概览
简要总结
The primary objective of T2P2 is to track the progression of T2D and related comorbidities and complications in the TODAY cohort as they transition to young adulthood. We hypothesize that:
- Youth-onset type 2 diabetes (T2D) will progress rapidly and result in high rates of diabetes-related medical complications and comorbidities.
- The rapid rate of progression is related to increased insulin resistance characteristic of puberty, worse β-cell function, degree of glycemic control, control of non-glycemic factors, and obesity itself.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in TODAY clinical trial.
排除标准
- 未提供
结局指标
主要结局
peripheral diabetic neuropathy
时间窗: every 12 months
a microvascular complication defined as the presence of Michigan Neuropathy Screening Instrument (MNSI) exam score \>2 and \<8 out of 10 appropriate responses to the Semmes-Weinstein monofilament (SW-MF) in either foot.
diabetic retinopathy
时间窗: year 4
a microvascular complication determined by fundus photography
arterial stiffness
时间窗: year 5
a macrovascular (cardiovascular) risk indicator determined by pulse wave velocity
overt diabetic nephropathy
时间窗: every 12 months
a microvascular complication determined by glomerular filtration rate \< 70 mL/min/1.73m2
cardiac function
时间窗: year 2
a macrovascular (cardiovascular) risk indicator determined by echocardiogram
microalbuminuria
时间窗: every 12 months
a microvascular complication determined by urine albumin excretion \>= 30 mg/day
cardiovascular risk lipid values
时间窗: every 12 months
a macrovascular (cardiovascular) risk indicator determined by abnormal lipid value for LDL (\>= 130 mg/dL) or triglycerides (\>= 300 mg/dL)
次要结局
- glycemic control(every 12 months)
- blood pressure(every 12 months)
- sleep function(years 2-3)
- insulin sensitivity and beta cell function(participant years 6 and 9 from baseline)
- healthcare usage(every 6 months)
- psychological disorder(every 12 months)
- body composition(every 12 months)
- eating disorder(every 12 months)
- health-related quality of life(every 12 months)
- life stress(every 12 months)