Clinical Trial: Effect of Metformin on Lactate Metabolism
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect of Metformin on Lactate Metabolism in Healthy Subjects
Brief Summary:
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.
Detailed Summary:
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.
- Outcome 2: Production of lactate following muscular exercise test.
- Outcome 3 and 3': Parameters modelizing elimination of lactate following exogenous lactate overload (bi-exponential model).
- Outcome 4 and 4': Parameters modelizing elimination of lactate following muscular exercise test (bi-exponential model).
Inclusion criteria:
- Healthy male subjects, 18 to 30 years
- Body mass index (BMI) between 21 and 25 kg/m2 inclusive
- Informed consent
Exclusion criteria :
- Ward of court
Sponsor: Centre de Recherche en Nutrition Humaine Rhone-Alpe
Current Primary Outcome: Lactate production following exogenous lactate overload
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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).
Original Secondary Outcome: Same as current
Information By: Centre de Recherche en Nutrition Humaine Rhone-Alpe
Dates:
Date Received: October 18, 2006
Date Started: December 2006
Date Completion:
Last Updated: October 6, 2008
Last Verified: October 2008