Effect of Metformin on Lactate Metabolism

Effect of Metformin on Lactate Metabolism in Healthy Subjects

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00390273

Enrollment

Registered

2006-10-19

Start date

2006-12-31

Completion date

2007-10-31

Last updated

2008-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlactatemia

Keywords

diabetes, metformin, hyperlactatemia

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.

Interventions

DRUGMetformin

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 30 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Lactate production following exogenous lactate overload	—

Secondary

Measure	Time frame
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).	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026