Effect of Metformin on Lactate Metabolism
Information source: Centre de Recherche en Nutrition Humaine Rhone-Alpe
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlactatemia
Intervention: Metformin (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Centre de Recherche en Nutrition Humaine Rhone-Alpe Official(s) and/or principal investigator(s):
Eric Fontaine, Pr, Principal Investigator, Affiliation: Centre Hospitalier Universitaire de Grenoble
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.
Clinical Details
Official title: Effect of Metformin on Lactate Metabolism in Healthy Subjects
Study design: Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety Study
Primary outcome: Lactate production following exogenous lactate overload
Secondary outcome: 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).
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
Minimum age: 18 Years.
Maximum age: 30 Years.
Gender(s): Male.
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
Locations and Contacts
Centre Hospitalier Universitaire de Grenoble, Grenoble cedex 9 38043, France
Additional Information
Starting date: December 2006
Ending date: October 2007
Last updated: October 5, 2007
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