Effect of Metformin on Lactate Metabolism | NCT00390273

Studies
Effect of Metformin on Lactate Metabolism

NCT00390273

Sponsor

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Status

Completed

Last Update Posted

Oct 7, 2008Estimated

Enrollment

20Actual

Phase

Phase 1Phase 2

Conditions

Hyperlactatemia

Interventions

Metformin

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EUDRACT 2006-001348-30

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Oct 18, 2006

First Submission Date that Met QC Criteria

Oct 18, 2006

First Posted Date

Oct 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2008

Last Update Posted Date

Oct 7, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Centre de Recherche en Nutrition Humaine Rhone-AlpeOTHER

Collaborators

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lactate production following exogenous lactate overload

Secondary Outcomes

Measure	Description	Time Frame
Production of lactate following muscular exercise test.
Parameters modelizing elimination of lactate following exogenous lactate overload (bi-exponential model).

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Fontaine, Pr	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Grenoble		Grenoble		38043	France

Condition Browse Module

MeSH Terms

ID	Term
D065906	Hyperlactatemia
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided