Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Peak Epinephrine Levels
研究概览
简要总结
A hyperinsulinemic-hypoglycemic clamp is an experimental procedure, which allows for hypoglycemia to be studied in a safe and controlled manner. The goal of this study is to establish the hyperinsulinemic-hypoglycemic clamp procedure at Pennington Biomedical Research Center in order to apply the knowledge gained to future studies which will determine the efficacy of our biomarker for predicting susceptibility to hypoglycemia. Additionally, our use of continuous glucose monitoring (CGM) during the clamp procedure will provide novel data regarding the accuracy of CGM during hypoglycemic conditions in a controlled research setting.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male or female
- •Ages 18-40 years
- •BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
- •Medically cleared for participation in the study
排除标准
- •History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
- •Average screening blood pressure >140/90 mmHg
- •History of cardiovascular disease
- •Pregnant, planning to become pregnant, or breastfeeding
- •Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.
结局指标
主要结局
Peak Epinephrine Levels
时间窗: 90 minute interval following initiation of insulin infusion
This value represents the average peak epinephrine value measured during the hypoglycemic clamp procedure
次要结局
- CGM Glucose(90 minute interval following initiation of insulin infusion)
研究者
David McDougal
Assistant Professor
Pennington Biomedical Research Center