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