Effect of Metformin on Lactate Metabolism

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Centre de Recherche en Nutrition Humaine Rhone-Alpe
ClinicalTrials.gov Identifier:
NCT00390273
First received: October 18, 2006
Last updated: October 6, 2008
Last verified: October 2008
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Metformin on Lactate Metabolism in Healthy Subjects

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
Investigators
Principal Investigator: Eric Fontaine, Pr University Hospital, Grenoble
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014