Effect of Metformin on Lactate Metabolism
Primary Purpose
Hyperlactatemia
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlactatemia focused on measuring diabetes, metformin, hyperlactatemia
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Universitaire de Grenoble
Outcomes
Primary Outcome Measures
Lactate production following exogenous lactate overload
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT00390273
First Posted
October 18, 2006
Last Updated
October 6, 2008
Sponsor
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00390273
Brief Title
Effect of Metformin on Lactate Metabolism
Official Title
Effect of Metformin on Lactate Metabolism in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlactatemia
Keywords
diabetes, metformin, hyperlactatemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Metformin
Primary Outcome Measure Information:
Title
Lactate production following exogenous lactate overload
Secondary Outcome Measure Information:
Title
Production of lactate following muscular exercise test.
Title
Parameters modelizing elimination of lactate following exogenous lactate overload (bi-exponential model).
Title
Parameters modelizing elimination of lactate following muscular exercise test (bi-exponential model).
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Fontaine, Pr
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Grenoble
City
Grenoble cedex 9
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect of Metformin on Lactate Metabolism
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