Phenotyping Children and Adults With Possible High or Low Genetic Risk for Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Glucose response to an oral glucose load
研究概览
简要总结
This study tests the hypothesis that non-diabetic individuals with a high genetic risk score for type 2 diabetes have impaired glucose tolerance and insulin resistance compared to those with a low genetic risk score for type 2 diabetes.
详细描述
The study team will recruit individuals based on genetic risk score for type 2 diabetes from the biobank populations who have agreed to be recontacted for future research. Each participant will undergo a frequently sampled four-hour oral glucose tolerance test and whole body DXA scan (dual-energy X-ray absorptiometry) in addition to baseline laboratory and history assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Data analyses (including by outcomes assessors and investigators) will be de-identified, and individuals performing laboratory analyses and DXA interpretation will be blinded to polygenic risk score for type 2 diabetes. Participants and nursing staff will not be informed of polygenic risk score at the time of the study.
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 10-70 years
- •Prior participant of the UPenn Biobank or Center for Applied Genomics Biobank and agreed to be recontacted for future research.
- •Adults with BMI 25kg/m2 or higher, children and adolescents with BMI 85th percentile or higher
排除标准
- •prior diagnosis of type 1, type 2, or secondary diabetes
- •use of medications that would impact glucose and insulin response such as steroids, metformin or other anti-diabetic medication
- •acute illness that may impact insulin and glucose dynamics
- •pregnancy
- •hypothalamic obesity or related genetic disorder of metabolism
- •recent systemic chemotherapy use
- •gastrointestinal impairment or surgery that may impact absorption
- •major organ system illness or any underlying condition requiring regular medication or treatment that could make implementation of the protocol or interpretation of the study results difficult
- •inability to comply with study protocol
结局指标
主要结局
Glucose response to an oral glucose load
时间窗: samples will be collected over four hours and these results will be used to calculate area under the curve
Glucose area under the curve after the 75g glucose beverage
次要结局
- Disposition index(samples will be collected over four hours after the 75g glucose beverage and these results will be used for mixed modeling)
- Visceral adiposity index(DXA scan will be obtained on the same day as the oral glucose test and will be completed in less than 30 minutes)
- HOMA-IR(calculated from baseline fasting insulin and glucose levels)
研究者
Jessica R.Wilson, MD, MS
Instructor in Medicine
University of Pennsylvania