Effect of a Sulfonylurea Compound on the Glucagon Response to Insulin-induced Hypoglycemia in Type 1 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- plasma glucagon concentrations during insulin induced hypoglycemia with and without glibenclamide pretreatment
研究概览
简要总结
We aim to demonstrate that oral administration of glibenclamide stimulates pancreatic glucagon secretion during hypoglycemia in insulin-deficient (C-peptide negative) patients with type 1 diabetes when compared to type 1 diabetic patients with residual insulin secretion (C-peptide positive).
详细描述
The glucagon response during insulin induced hypoglycemia and rate of glucose recovery will be monitored in 10 C-peptide positive and 10 C-Peptide negative patients with type 1 DM following the application of glibenclamide and placebo in a randomized, single-blind, cross-over study.
Cognitive function during hypoglycemia with and without glibenclamide pretreatment will be a secondary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 50 years
- •Patients diagnosed with C-peptide negative diabetes type 1 (C-peptide <200 pmol/L 6 min after 1 mg glucagon i.v. at plasma glucose concentrations between 5 and 11 mmol/l)
- •Patients diagnosed with C-peptide positive diabetes type 1 (C-peptide > 500 pmol/l 6 min after 1 mg glucagon i.v. at plasma glucose concentrations between 5 and 11 mmol/l)
- •Stable metabolic control; HbA1c levels <8.0 % and without episodes of antecedent severe hypoglycemias in the past four weeks
排除标准
- •Patients treated with medications potentially interfering with glucose metabolism, such as systemic steroids, immunosuppressive drugs (cyclosporine, tacrolimus, sirolimus), highly active antiretroviral therapy
- •History coronary artery disease
- •History of epilepsy or seizures
- •Current smokers
- •Any significant or unstable hepatic, cardiac, pulmonary, renal, neurological, musculoskeletal, hematological or endocrine disease.
- •Pregnant or breast feeding women
- •Woman of childbearing potential not using a reliable method of birth control such as oral contraceptives or IUD.
- •Subjects refusing or unable to give written informed consent
研究组 & 干预措施
A
Glibenclamide 5 mg tablets
干预措施: glibenclamide (Drug)
B
placebo capsules
干预措施: placebo (Drug)
结局指标
主要结局
plasma glucagon concentrations during insulin induced hypoglycemia with and without glibenclamide pretreatment
时间窗: cross-sectional
次要结局
- rate of glucose recovery following insulin induced hypoglycemia with and without glibenclamide pretreatment(cross-sectional)
- cognitive function during insulin induced hypoglycemia with and without glibenclamide pretreatment(cross-sectional)