Counter-regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Maximum Epinephrine Response (LBGI Groups)
研究概览
简要总结
The researchers plan to test the following hypothesis:
A good level of glucose control in Type 1 Diabetes Mellitus (T1DM) is dependent on two levels of feedback from the body:
- the transport of insulin through small blood vessels: suggesting that hypoglycemia leads to increased insulin sensitivity which then causes recurrent hypoglycemia;
- the endocrine level, defined as insulin-glucose interaction and hormonal counter-regulation.
The researchers plan to investigate the relationships between hypoglycemia, insulin transport, and counter-regulation. This study will ultimately lead to a better understanding of risk for recurrent hypoglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in and satisfied all of the inclusion criteria of NCT00315939
- •18 years of age or older
- •Have Type 1 Diabetes Mellitus defined by American Diabetes Association criteria or judgment of physician
- •Since our major goal is the investigation of hypoglycemia, we will preferentially recruit patients with a history of severe hypoglycemia/moderate hypoglycemia anticipating that approximately (~) half of the recruited subjects will have had two or more severe or moderate hypoglycemia episodes in the past 12 months
排除标准
- •Age < 18
- •Pregnancy
- •Use of oral steroids
- •Hematocrit < 36% (females); < 38% (males)
- •Symptomatic heart disease (e.g., history of myocardial infarction, history of coronary bypass or stenting procedure, angina, episode of chest pain of cardiac etiology with documented EKG changes, positive stress test or catheterization with coronary blockages > 50%)
- •History of an ischemic cerebrovascular event
- •Active substance abuse
- •Psychosis
- •Mental retardation
- •Severe depression
结局指标
主要结局
Maximum Epinephrine Response (LBGI Groups)
时间窗: 285 min (time of clamp)
Mean maximum epinephrine response during induced hypoglycemia is the average of subjects' maximum concentration of all epinephrine measurements taken at plasma glucose level lower than 70mg/dL. Low blood glucose index (LBGI) is a metric to calculate the risk for hypoglycemia based on frequency and extent of past events based on SMBG readings. In studies, the LBGI typically accounted for 40-55% of the variance of future significant hypoglycemia in the subsequent 3-6 months. The LBGI has established risk categories: Low Risk, LBGI \< 2.5; Moderate Risk, 2.5 \< LBGI \< 5; and High Risk, LBGI \> 5, indicating an over 10-fold increase in future severe hypoglycemia from the lowest to the highest risk category.
次要结局
- Maximum Epinephrine Response (ADRR Groups)(285 min (time of clamp))
研究者
Boris Kovatchev, PhD
Professor
University of Virginia