Official Title: “Effect of Metformin on Lactate Metabolism in Healthy Subjects”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety Study

Study Primary Completion Date: October 2007

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 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.

Intervention(s) in this Clinical Trial

• Drug: Metformin

Primary Measures

• Lactate production following exogenous lactate overload

Secondary Measures

• 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).

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 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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 30 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Centre de Recherche en Nutrition Humaine Rhone-Alpe

Overall Clinical Trial Officials and Contacts

Eric Fontaine, Pr Principal Investigator Centre Hospitalier Universitaire de Grenoble  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00390273

Study ID Number: CRNHRA-06-001

ClinicalTrials.gov Identifier: NCT00390273

Health Authority: France: Ministry of Health