Effect of Metformin on Lactate Metabolism

October 6, 2008 updated by: Centre de Recherche en Nutrition Humaine Rhone-Alpe

Effect of Metformin on Lactate Metabolism in Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Lactate production following exogenous lactate overload

Secondary Outcome Measures

Outcome Measure
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Eric Fontaine, Pr, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

October 18, 2006

First Submitted That Met QC Criteria

October 18, 2006

First Posted (Estimate)

October 19, 2006

Study Record Updates

Last Update Posted (Estimate)

October 7, 2008

Last Update Submitted That Met QC Criteria

October 6, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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