Effect of Metformin on Lactate Metabolism - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 2006

Last Updated Date

October 6, 2008

Start Date ^ICMJE

December 2006

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Lactate production following exogenous lactate overload

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00390273 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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).

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effect of Metformin on Lactate Metabolism

Official Title ^ICMJE

Effect of Metformin on Lactate Metabolism in Healthy Subjects

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 Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety Study

Condition ^ICMJE

Hyperlactatemia

Intervention ^ICMJE

Drug: Metformin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 30 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00390273

Responsible Party

Study ID Numbers ^ICMJE

CRNHRA-06-001, EUDRACT 2006-001348-30

Study Sponsor ^ICMJE

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Collaborators ^ICMJE

Merck

Investigators ^ICMJE

Principal Investigator:

Eric Fontaine, Pr

Centre Hospitalier Universitaire de Grenoble

Information Provided By

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP