Effect of Metformin on Lactate Metabolism

Phase 1

Completed

• Conditions: Hyperlactatemia

• Registration Number: NCT00390273
• Lead Sponsor: Centre de Recherche en Nutrition Humaine Rhone-Alpe

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.

Study Timeline

• Study First Submitted: 2006-10-18
• Study First Submitted QC: 2006-10-18
• Study First Posted: 2006-10-19
• Study Start: 2006-12
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-06
• Last Update Posted: 2008-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Lactate production following exogenous lactate overload

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Grenoble; 🇫🇷 Grenoble cedex 9, France