Effect of Metformin on Lactate Metabolism
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...
Brief Summary
Official Title: “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 Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: October 2007
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Metformin
Outcome Measures for this Clinical Trial
Primary Measures
- Lactate production following exogenous lactate overload
Secondary 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).
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 30 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Centre de Recherche en Nutrition Humaine Rhone-Alpe Other
Overall Clinical Trial Officials and Contacts
Eric Fontaine, Pr Principal Investigator Centre Hospitalier Universitaire de Grenoble
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00390273
Study ID Number: CRNHRA-06-001
ClinicalTrials.gov Identifier: NCT00390273
Health Authority: France: Ministry of Health
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00390273
