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Completed

NCT Number: NCT00390273

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.

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Key information

Conditions

Hyperlactatemia Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre Hospitalier Universitaire de Grenoble

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

Primary outcomes

  1. Lactate production following exogenous lactate overload

Secondary outcomes

  1. Production of lactate following muscular exercise test.

  2. Parameters modelizing elimination of lactate following exogenous lactate overload (bi-exponential model).

  3. Parameters modelizing elimination of lactate following muscular exercise test (bi-exponential model).

Sponsors and collaborators

Lead sponsor

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Effect of Metformin on Lactate Metabolism in Healthy Subjects

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 19, 2006
Registry last updated
Oct 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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