Risk of Hypoglycemia in Type 2 Diabetes - Effects of Glibenclamide and Exercise on Cardiovascular, Hormonal, and Metabolic Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Number of hypoglycemic events
研究概览
简要总结
The aim of this study is to establish the risk and frequency of non-symptomatic hypoglycemia in type 2 diabetes under previous therapy with glibenclamide. Participants will be monitored via a continuous glucose monitoring system in a standardized clinical setting during day and night time, implementing meals and exercise of moderate intensity performed in the postprandial state.
详细描述
The day-to-day change of blood glucose is associated with the frequency of vascular complications and the quality of life of diabetic patients. In this study the frequency of hypoglycemic events in combination with postprandial hyperglycemia in type 2 diabetic patients on oral insulinotropic therapy will be observed. Using more sophisticated technology than before the probability of type 2 diabetic patients on glibenclamide to experience hypoglycemic episodes will be registered. Hypoglycemia is prone to cardiovascular complications in type 2 diabetic patients due to concomitant dysregulation of blood flow. With standardized test meals followed by exercise in a clinical setting hormonal counterregulation and cardiovascular parameters associated with hypoglycemia will be identified. The acute effect of different conditions of exercise and a single dose of either glibenclamide or placebo will be followed each day during the total three-day observation period. Thus we will evaluate the frequency of and the risk factors associated with hypoglycemia and meal-related hyperglycemia in type 2 diabetic patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes on glibenclamide with or without
- •Glycated hemoglobin ≤ 7.5%
- •Stable dosage for three weeks
排除标准
- •HbA1c > 7.5%
- •Fasting C-peptide below normal
- •Concurrent infectious disease
- •Pregnancy
- •Malignant disease
- •Inability to give informed consent
研究组 & 干预措施
1
Type 2 diabetic patients on glibenclamide at individual dosage up to 7 mg/day for more than one year prone to hypoglycemic events
干预措施: Glibenclamide (Drug)
结局指标
主要结局
Number of hypoglycemic events
时间窗: 3 days
次要结局
- Secretion of hormones increasing blood glucose, effect of exercise on hypoglycemic events, postprandial glucose excursions, heart rate and forearm blood flow at hypoglycemia(3 days)
研究者
Thomas Linn
Univ.-Prof. Dr. med.
University of Giessen