Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390273
Status:
COMPLETED
Last Update Posted:
2008-10-07
First Post:
2006-10-18
Brief Title:
Effect of Metformin on Lactate Metabolism
Sponsor:
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Organization:
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Study Overview
Official Title:
Effect of Metformin on Lactate Metabolism in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 kgm2 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
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 kgm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT 2006-001348-30 | None | None | None |