Effect of Metformin on Lactate Metabolism

Human Nutrition Research Centers (CRNH)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hyperlactatemia

Treatments

Drug: Metformin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00390273

EUDRACT 2006-001348-30

CRNHRA-06-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Male

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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