NCT02145572已完成不适用
Metabolomic Profiling in Adolescents With Obesity and Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Differences in metabolite concentrations measured by mass spectrometry, comparing blood and urine samples from obese adolescents with type 2 diabetes, obese adolescents without diabetes, and age-matched healthy non-obese controls.
研究概览
简要总结
The purpose of this study is to identify unique metabolite signatures associated with the development of Type 2 diabetes and diabetic kidney disease in children.
We have a sub-study, with the purpose to validate the presence of a genetic marker (DENND1A) in the urine of adolescent females with polycystic ovarian syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 13-19 years
- •Gender: male and female
- •Ethnic background: any
- •Obesity will be defined as BMI >95th percentile for age/gender
- •Diagnosis of diabetes will be defined by current American Diabetes Association criteria
- •Diabetes duration < 2.5 years
- •Absence of pancreatic autoimmunity (GAD65 and ICA512 and Insulin autoantibody)
- •Adult caregiver willing to actively support study participation
- •Signed parental informed consent form and adolescent assent form
- •For PCOS substudy, the diagnosis of PCOS will be defined according to the 1990 US National Institute of Health (NIH) criteria (oligomenorrhea, clinical or biochemical signs of hyperandrogenism, and exclusion of other known disorders)
排除标准
- •Creatinine clearance <60 mL/min (calculated from estimated GFR)
- •Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation.
- •For PCOS substudy, use of medications that effect androgen levels in the blood (i.e. oral contraceptive pills, or metformin) for the last 3 months prior to enrollment
结局指标
主要结局
Differences in metabolite concentrations measured by mass spectrometry, comparing blood and urine samples from obese adolescents with type 2 diabetes, obese adolescents without diabetes, and age-matched healthy non-obese controls.
时间窗: 2 years
次要结局
未报告次要终点
研究者
Dr Jane Kim
Associate Physician, Department of Pediatrics
University of California, San Diego
研究点 (1)
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