NCT00390273已完成1 期
Effect of Metformin on Lactate Metabolism in Healthy Subjects
Centre de Recherche en Nutrition Humaine Rhone-Alpe2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Lactate production following exogenous lactate overload
研究概览
简要总结
The main objective of this study is to evaluate the influence of metformin on lactate metabolism.
The main outcome is the lactate production following an exogenous lactate overload in healthy male subjects without metformin and one week later with metformin.
详细描述
Study design: Physiological study, controlled, open, non randomised
Healthy male subjects, 18 to 30 years old
Principal objective : To evaluate the influence of metformin on lactate metabolism (production) following exogenous lactate overload.
- Objective 2: To evaluate the influence of metformin on lactate metabolism (production) after muscular exercise.
- Objective 3: To evaluate the influence of metformin on lactate metabolism (elimination) after exogenous lactate overload.
- Objective 4: To evaluate the influence of metformin on lactate metabolism (elimination) after muscular exercise.
Principal outcome : Lactate production following exogenous lactate overload.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects, 18 to 30 years
- •Body mass index (BMI) between 21 and 25 kg/m2 inclusive
- •Informed consent
排除标准
- •Ward of court or under guardianship (sheltered adults)
- •Adult unable to express their consent
- •Person deprived of freedom by judicial or administrative decision
- •Person hospitalised without their consent
- •Person under legal protection
- •Existence of a previously diagnosed pathology
- •Existence of a metabolic condition (obesity, diabetes) or a family history of such
- •Ongoing medical treatment
结局指标
主要结局
Lactate production following exogenous lactate overload
次要结局
- Production of lactate following muscular exercise test.
- Parameters modelizing elimination of lactate following exogenous lactate overload (bi-exponential model).
- Parameters modelizing elimination of lactate following muscular exercise test (bi-exponential model).
研究者
研究点 (2)
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