NCT00631033已完成2 期
Diazoxide-mediated Insulin Suppression in Hyperinsulinemic Obese Men, Part III
Rijnstate Hospital1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine whether there is an additive effect of metformine on the weight reduction of obese hyperinsulinemic men who are treated with diazoxide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age 25-50 years
- •BMI 30-35 kg/m2
- •stable body weight during 3 months before the start of the study
- •glucose <= 6.0 mmol/L
- •C-peptide >= 1.0 nmol/L
- •HbA1c <= 6.0%
排除标准
- •comorbidity
- •medication
- •serum creatinine > 120 micromol/L
- •liver enzymes > 2 times upper limits of normal
- •alcohol use > 2 alcoholic drinks a day
- •drug abuse
- •cessation of smoking less than 6 months ago
研究组 & 干预措施
3
Experimental
Metformin + Diazoxide
干预措施: Metformin + Diazoxide (Drug)
1
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
2
Experimental
Diazoxide
干预措施: Diazoxide (Drug)
研究者
研究点 (1)
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