Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men: a Dose Response Study, Part II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- body weight
研究概览
简要总结
The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia.
Obesity is associated with markedly elevated plasma insulin levels throughout the day. The concept is that obese subjects predominantly develop lean tissue resistance against the glucoregulatory actions of insulin, but remain relatively sensitive to the lipogenic and antilipolytic effects of insulin in adipose tissue. According to this theory, suppression of hyperinsulinism by diazoxide, a well known inhibitor of glucose stimulated insulin secretion, might be useful to treat obesity because it will help to reverse the process of lipid storage.
详细描述
The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia.
Study design:
This study is an open-labelled, non-randomized, phase IIa study.
Treatment:
During a 6 month period, the dosage of Diazoxide will be raised gradually until a maximum of 900 mg/day, under control of bloodpressure and glucose levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •fasting glucose < 7.0 mmol/L
- •fasting C-peptide plasma level > 1.0 nmol/L
- •HbA1c of 6.0% or lower
- •Absence of comorbidity
- •Absence of medication use
排除标准
- •Plasma Creatinine > 120 micromol/L
- •Liverenzymes > 2 times the upper normal limit
- •Alcohol use > 2 units/day
- •Illicit drug use
- •Quit smoking less than 6 months ago
结局指标
主要结局
body weight
abdominal circumference
body composition measured by Dual Energy X-ray Absorptiometry
glucose tolerance
次要结局
未报告次要终点