ClinicalTrials.gg
CompletedNCT00390273Updated Oct 7, 2008

Effect of Metformin on Lactate Metabolism

A Phase 1/2 interventional study of Metformin in Hyperlactatemia, sponsored by Centre de Recherche en Nutrition Humaine Rhone-Alpe. Completed at 1 site in France. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-10-07.

Sponsored by Centre de Recherche en Nutrition Humaine Rhone-Alpe · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study 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.

Read the 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.
02

Conditions studied

  • Hyperlactatemia

Keywords

  • diabetes
  • metformin
  • hyperlactatemia
03

In context

Hyperlactatemia

50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.

This study's enrollment of 20 is below the median of 38 across 32 interventional studies indexed under Hyperlactatemia.

Browse Hyperlactatemia studies →

Lead sponsor

Centre de Recherche en Nutrition Humaine Rhone-Alpe is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy male subjects, 18 to 30 years
  • (BMI) between 21 and 25 kg/m2 inclusive

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Interventions

06

What researchers measure

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).

07

Study locations

1 site
  • Centre Hospitalier Universitaire de Grenoble
    Grenoble cedex 9, 38043, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2006, a primary completion of Oct 2007 and a completion of Oct 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2006
First posted
Oct 19, 2006
Start
Dec 2006
Primary completionActual
Oct 2007
CompletionActual
Oct 2007
Last update
Oct 7, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 7, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00390273
Lead sponsor
Centre de Recherche en Nutrition Humaine Rhone-Alpe
First posted
Oct 19, 2006
Start date
Dec 2006
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Oct 7, 2008

Study contacts

Eric Fontaine, Pr
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Metformin

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