Effect of Metformin on Lactate Metabolism

Study Overview
=================
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 Description
-----------------
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.

Official Title
-----------------
Effect of Metformin on Lactate Metabolism in Healthy Subjects

Conditions
-----------------
Hyperlactatemia

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Metformin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate production following exogenous lactate overload |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, metformin, hyperlactatemia