Effect of Metformin on Lactate Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Hyperlactatemia

Keywords

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diabetes metformin hyperlactatemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Metformin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Eric Fontaine, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Centre Hospitalier Universitaire de Grenoble

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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EUDRACT 2006-001348-30

Identifier Type: -

Identifier Source: secondary_id

CRNHRA-06-001