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.
ConditionPharmacogenetics of Metformin
InterventionDrug: Metformin
PhasePhase 4
SponsorUniversity of Southern Denmark
Responsible PartyUniversity of Southern Denmark
ClinicalTrials.gov IdentifierNCT01400191
First ReceivedJuly 21, 2011
Last UpdatedJuly 21, 2011
Last verifiedJune 2011

Tracking Information[ + expand ][ + ]

First Received DateJuly 21, 2011
Last Updated DateJuly 21, 2011
Start DateAugust 2011
Estimated Primary Completion DateMay 2012
Current Primary Outcome MeasuresHepatic gluconeogenesis [Time Frame: 48 hours] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleThe Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1
Official TitleThe 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
ConditionPharmacogenetics of Metformin
InterventionDrug: 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)
  • Active Comparator: Homozygote wildtype OCT1
  • Active Comparator: Heterozygote OCT1
  • Active Comparator: Homozygote OCT1 variant

Recruitment Information[ + expand ][ + ]

Recruitment StatusNot yet recruiting
Estimated Enrollment36
Estimated Completion DateMay 2012
Estimated Primary Completion DateMay 2012
Eligibility Criteria
Inclusion Criteria:

- Healthy volunteers

- Written consent

- Genotyped in OCT1 for (M420del and R61C)

Exclusion Criteria:

- Daily medication

- Alcohol abuse

- Pregnancy

- Breastfeeding
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsContact: Mette Marie Hougaard Christensen, MD
+4565503678
mmchristensen@health.sdu.dk
Location CountriesDenmark

Administrative Information[ + expand ][ + ]

NCT Number NCT01400191
Other Study ID NumbersAKF 379
Has Data Monitoring CommitteeYes
Information Provided ByUniversity of Southern Denmark
Study SponsorUniversity of Southern Denmark
CollaboratorsRegion Southern Denmark
Investigators Principal Investigator: Mette Marie Hougaard Christensen, MD Clinical pharmacology, Institute of Public Health, SDU
Verification DateJune 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.dk
Principal Investigator: Mette Marie H Christensen, MD
Not yet recruiting