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The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1

This study is not yet open for participant recruitment.
Verified June 2011 by University of Southern Denmark
Sponsor:
Collaborator:
Region Southern Denmark
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01400191
First received: July 21, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  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.


Condition Intervention Phase
Pharmacogenetics of Metformin
 Drug: Metformin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1 (OCT1) in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Hepatic gluconeogenesis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: August 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Homozygote wildtype OCT1 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.
Active Comparator: Heterozygote OCT1 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.
Active Comparator: Homozygote OCT1 variant 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Written consent
  • Genotyped in OCT1 for (M420del and R61C)

Exclusion Criteria:

  • Daily medication
  • Alcohol abuse
  • Pregnancy
  • Breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400191

Contacts
Contact: Mette Marie Hougaard Christensen, MD +4565503678 mmchristensen@health.sdu.dk
Contact: Kim Brøsen, Professor +4565503751 kbrosen@health.sdu.dk

Locations
Denmark
Clinical pharmacology, Institute og public health, University of Southern Denmark Not yet recruiting
Odense, Denmark, 5000
Contact: Mette Marie H Christensen, MD     +4565503678     mmchristensen@health.sdu.dk    
Contact: Kim Brøsen, Professor     +4565503751     kbrosen@health.sdu.dk    
Principal Investigator: Mette Marie H Christensen, MD            
Sponsors and Collaborators
University of Southern Denmark
Region Southern Denmark
Investigators
Principal Investigator: Mette Marie Hougaard Christensen, MD Clinical pharmacology, Institute of Public Health, SDU
  More Information

No publications provided

Responsible Party: Mette Marie Hougaard Christensen, Clinical Pharmacolocy, Institute of Public Health, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01400191     History of Changes
Other Study ID Numbers: AKF 379
Study First Received: July 21, 2011
Last Updated: July 21, 2011
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
Metformin
Hypoglycemic Agents
Diabetes Mellitus, Type 2
 Gluconeogenesis
Pharmacodynamics
Pharmacogenetics

Additional relevant MeSH terms:
Hypoglycemic Agents
Metformin
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013