NCT00390273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 7, 2008

Status Verified

October 1, 2008

Enrollment Period

10 months

First QC Date

October 18, 2006

Last Update Submit

October 6, 2008

Conditions

Hyperlactatemia

Keywords

diabetesmetforminhyperlactatemia

Outcome Measures

Primary Outcomes (1)

  • Lactate production following exogenous lactate overload

Secondary Outcomes (3)

  • 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).

Interventions

MetforminDRUG

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

HyperlactatemiaDiabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Eric Fontaine, Pr

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2006

First Posted

October 19, 2006

Study Start

December 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

October 7, 2008

Record last verified: 2008-10

Locations

FR(1)