NCT00390273

Effect of Metformin on Lactate Metabolism

Effect of Metformin on Lactate Metabolism in Healthy Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Centre de Recherche en Nutrition Humaine Rhone-Alpe · Academic / Other
• Sex: Male
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperlactatemia

Interventions

Type	Name	Description
DRUG	Metformin

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-10-19
• Last updated: 2008-10-07

Locations

1 site across 1 country: France