Effect of Fasting on Hypoglycemic Counterregulation in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Hepatic glucose production
研究概览
简要总结
Iatrogenic hypoglycemia is still considered to be the number one barrier to effective glycemic control in patients with type 1 diabetes (T1D). In a previous study, it was observed in people without diabetes that fasting can be detrimental to the hormonal and hepatic responses to insulin-induced hypoglycemia. In the experiments described herein, the impact fasting has on hypoglycemic counterregulation in people with T1D will be determined.
详细描述
Because patients with type 1 diabetes (T1D) are required to estimate and administer their own insulin requirements, they frequently overestimate their needs. This often leads to debilitating insulin-induced hypoglycemia, which is the number one barrier to the safe, effective management of glycemia in this population. In addition to the difficulty estimating one's own insulin requirements after a meal, counterregulatory hormone responses to hypoglycemia are impaired in patients with T1D, thereby reducing hepatic glucose production (HGP) and increasing the depth and duration of the hypoglycemic episode.
The discovery of ways by which counterregulatory responses to hypoglycemia can be improved in people with T1D is a priority. In previous experiments, it was observed that fasting reduces counterregulatory hormone secretion in healthy humans during insulin-induced hypoglycemia, thereby reducing hepatic glucose production (HGP). Therefore, the studies proposed herein will determine the effect of fasting on hypoglycemic counterregulation in people with T1D. It is hypothesized that fasting will diminish the hormonal and hepatic responses to insulin-induced hypoglycemia.
Each subject will undergo two trials; one where they eat an isocaloric breakfast and lunch prior to an insulin-induced hypoglycemic challenge and a second one during which they remain fasted prior to the hypoglycemic challenge. This study design will allow assessment of the relationship between fasting and the counterregulatory responses to insulin-induced hypoglycemia in a population that is particularly vulnerable to low blood sugar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females of any race or ethnicity
- •non-obese (BMI < or = to 30)
- •have a diagnosis of type 1 diabetes
- •C-peptide negative
排除标准
- •pregnant women
- •cigarette smoking
- •Taking inflammation-targeting steroids (e.g., prednisone).
- •Taking medications targeting adrenergic signaling (e.g., beta-blockers, bronchodilators).
- •Hematocrit less than 33%.
- •Presence of HIV or hepatitis (due to their deleterious effects on the liver).
- •The presence of cardiovascular or peripheral vascular disease.
- •The presence of neuropathy, retinopathy or nephropathy.
- •A detection of the presence of any other disease or condition by one of the study doctors, that would be expected to confound the responses to insulin-induced hypoglycemia or make participation in the study dangerous to the individual.
结局指标
主要结局
Hepatic glucose production
时间窗: During procedure, up to 2.5 hours
From plasma
Glucagon
时间窗: During procedure, up to 2.5 hours
From plasma
Glucose infusion rate
时间窗: During procedure, up to 2.5 hours
Amount of glucose required to maintain glycemia at \~55 mg/dL.
次要结局
- Peripheral glucose uptake(During procedure, up to 2.5 hours)
- Epinephrine(During procedure, up to 2.5 hours)
研究者
Jason Winnick
Principal Investigator
University of Cincinnati