NCT05055219已完成不适用
Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 772
- 试验地点
- 1
- 主要终点
- Progression of glucose tolerance
研究概览
简要总结
The purpose of this study is to evaluate the longitudinal test performance of an array of conventional biomarkers of glycemia, including Hemoglobin A1c (HbA1c), and novel metabolomic biomarkers for identifying progression of glucose tolerance (normal to prediabetes or prediabetes to diabetes) in an overweight and obese pediatric cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 8 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Groups 1 and 2 (overweight and obese groups):
- •Age 8-17 years for the visits #1 and #2, individuals can be as old as 22 years for follow-up visits #3 and 4
- •Overweight or obese, as defined by a BMI ≥ 85th% & <95th% or BMI ≥ 95th%, respectively by age and sex, and for those 16 years and older, BMI ≥25 and <30 and BMI ≥30
- •For Group 2 only: previously completed visits 1-2 in 2007-2013 and formally agreed to be re-contacted for study purposes
- •Group 3 (Normal weight controls):
- •Age 8-17 years
- •Healthy weight, as defined by a BMI ≥ 5th percentile & < 85th percentile, respectively by age and sex
排除标准
- •Previous diagnosis of type 1 diabetes
- •Use of concurrent medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin)
- •Verbal report of Pregnancy
结局指标
主要结局
Progression of glucose tolerance
时间窗: Up to 5 years
Normal glucose tolerance, prediabetes, or diabetes
次要结局
未报告次要终点
研究者
Joyce Lee
MD, MPH
University of Michigan
研究点 (1)
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