Clinical trial NCT00390273: Effect of Metformin on Lactate Metabolism
Official title: Effect of Metformin on Lactate Metabolism in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hyperlactatemia
Keywords: diabetes
metformin
hyperlactatemia
Lead sponsor: Centre de Recherche en Nutrition Humaine Rhone-Alpe
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2006-10-19
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Lactate production following exogenous lactate overload
Secondary outcomes:
measure: Production of lactate following muscular exercise test.
measure: Parameters modelizing elimination of lactate following exogenous lactate overload (bi-exponential model).
measure: Parameters modelizing elimination of lactate following muscular exercise test (bi-exponential model).
Other outcomes:
Locations:
city: Grenoble cedex 9
country: France
facility: Centre Hospitalier Universitaire de Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Eric Fontaine, Pr
role: PRINCIPAL_INVESTIGATOR
References: