Effect of Metformin on Lactate Metabolism

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Hyperlactatemia

Clinical Trial Details

NCT number	NCT00390273
Study type	Interventional
Source	Centre de Recherche en Nutrition Humaine Rhone-Alpe
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	December 2006
Completion date	October 2007

View Details

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