Effect of Metformin on Lactate Metabolism - Full Text View

Sponsor:	Centre de Recherche en Nutrition Humaine Rhone-Alpe
Collaborator:	Merck
Information provided by:	Centre de Recherche en Nutrition Humaine Rhone-Alpe
ClinicalTrials.gov Identifier:	NCT00390273

Purpose

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.

Condition	Intervention	Phase
Hyperlactatemia	Drug: Metformin	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety Study
Official Title:	Effect of Metformin on Lactate Metabolism in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Centre de Recherche en Nutrition Humaine Rhone-Alpe:

Primary Outcome Measures:

Lactate production following exogenous lactate overload

Secondary Outcome Measures:

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).

Enrollment:	20
Study Start Date:	December 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390273

Locations

France
Centre Hospitalier Universitaire de Grenoble
Grenoble cedex 9, France, 38043

Sponsors and Collaborators

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Merck

Investigators

Principal Investigator:

Eric Fontaine, Pr

Centre Hospitalier Universitaire de Grenoble

More Information

No publications provided

Study ID Numbers:	CRNHRA-06-001, EUDRACT 2006-001348-30
Study First Received:	October 18, 2006
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00390273 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Centre de Recherche en Nutrition Humaine Rhone-Alpe:

diabetes
metformin
hyperlactatemia

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Metformin
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009