The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1
Overview[ - collapse ][ - ]
Purpose | The aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy volunteers with functional OCT1-transporters. |
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Condition | Pharmacogenetics of Metformin |
Intervention | Drug: Metformin |
Phase | Phase 4 |
Sponsor | University of Southern Denmark |
Responsible Party | University of Southern Denmark |
ClinicalTrials.gov Identifier | NCT01400191 |
First Received | July 21, 2011 |
Last Updated | July 21, 2011 |
Last verified | June 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | July 21, 2011 |
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Last Updated Date | July 21, 2011 |
Start Date | August 2011 |
Estimated Primary Completion Date | May 2012 |
Current Primary Outcome Measures | Hepatic gluconeogenesis [Time Frame: 48 hours] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1 |
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Official Title | The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1 (OCT1) in Healthy Volunteers |
Brief Summary | The aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy volunteers with functional OCT1-transporters. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research |
Condition | Pharmacogenetics of Metformin |
Intervention | Drug: Metformin Initially all the healthy volunteers have their basal gluconeogenesis measured during 44 hours of fasting. Afterwards Metformin is administrated for 7 days at 8 am and 8 pm (day 1: 500 mg in the morning, 500 mg in the evening; day 2: 500 mg in the morning, 1000 mg in the evening; day 3, 4, 5, 6: 1000 mg in the morning and 1000 mg evening, day 7: 1000 mg in the evening) The last 44 hours of the metformin treatment period the volunteers are fasting and their gluconeogenesis are measured again. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Not yet recruiting |
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Estimated Enrollment | 36 |
Estimated Completion Date | May 2012 |
Estimated Primary Completion Date | May 2012 |
Eligibility Criteria | Inclusion Criteria: - Healthy volunteers - Written consent - Genotyped in OCT1 for (M420del and R61C) Exclusion Criteria: - Daily medication - Alcohol abuse - Pregnancy - Breastfeeding |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Contact: Mette Marie Hougaard Christensen, MD +4565503678 mmchristensen@health.sdu.dk |
Location Countries | Denmark |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01400191 |
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Other Study ID Numbers | AKF 379 |
Has Data Monitoring Committee | Yes |
Information Provided By | University of Southern Denmark |
Study Sponsor | University of Southern Denmark |
Collaborators | Region Southern Denmark |
Investigators | Principal Investigator: Mette Marie Hougaard Christensen, MD Clinical pharmacology, Institute of Public Health, SDU |
Verification Date | June 2011 |
Locations[ + expand ][ + ]
Clinical pharmacology, Institute og public health, University of Southern Denmark | Odense, Denmark, 5000 Contact: Mette Marie H Christensen, MD | +4565503678 | mmchristensen@health.sdu.dkPrincipal Investigator: Mette Marie H Christensen, MD Not yet recruiting |
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