Effect of Metformin on Lactate Metabolism
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Hyperlactatemia |
| Intervention | Drug: Metformin |
| Phase | Phase 1/Phase 2 |
| Sponsor | Centre de Recherche en Nutrition Humaine Rhone-Alpe |
| Responsible Party | Centre de Recherche en Nutrition Humaine Rhone-Alpe |
| ClinicalTrials.gov Identifier | NCT00390273 |
| First Received | October 18, 2006 |
| Last Updated | October 6, 2008 |
| Last verified | October 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 18, 2006 |
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| Last Updated Date | October 6, 2008 |
| Start Date | December 2006 |
| Estimated Primary Completion Date | October 2007 |
| Current Primary Outcome Measures | Lactate production following exogenous lactate overload |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Effect of Metformin on Lactate Metabolism |
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| Official Title | Effect of Metformin on Lactate Metabolism in Healthy Subjects |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 1/Phase 2 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Hyperlactatemia |
| Intervention | Drug: Metformin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
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| Estimated Enrollment | 20 |
| Estimated Completion Date | October 2007 |
| Estimated Primary Completion Date | October 2007 |
| 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 |
| Gender | Male |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | France |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00390273 |
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| Other Study ID Numbers | CRNHRA-06-001 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Centre de Recherche en Nutrition Humaine Rhone-Alpe |
| Study Sponsor | Centre de Recherche en Nutrition Humaine Rhone-Alpe |
| Collaborators | Merck Sharp & Dohme Corp. |
| Investigators | Principal Investigator: Eric Fontaine, Pr Centre Hospitalier Universitaire de Grenoble |
| Verification Date | October 2008 |
Locations[ + expand ][ + ]
| Centre Hospitalier Universitaire de Grenoble | Grenoble cedex 9, France, 38043 |
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