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

June 25, 2015 updated by: Mette Marie Hougaard Christensen, University of Southern Denmark

The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1 (OCT1) in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Clinical pharmacology, Institute og public health, University of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Daily medication
  • Alcohol abuse
  • Pregnancy
  • Breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Homozygote wildtype OCT1
Drug: Metformin
The study was designed as a randomized, cross-over trial with a washout period of at least 4 weeks between the phases. In both phases, the volunteers fasted for 42 h. This was done in order to include an evaluation of the pharmacodynamic effect of metformin on the glucose production in fasting healthy volunteers.
Active Comparator: Heterozygote OCT1
Drug: Metformin
The study was designed as a randomized, cross-over trial with a washout period of at least 4 weeks between the phases. In both phases, the volunteers fasted for 42 h. This was done in order to include an evaluation of the pharmacodynamic effect of metformin on the glucose production in fasting healthy volunteers.
Active Comparator: Homozygote OCT1 variant
Drug: Metformin
The study was designed as a randomized, cross-over trial with a washout period of at least 4 weeks between the phases. In both phases, the volunteers fasted for 42 h. This was done in order to include an evaluation of the pharmacodynamic effect of metformin on the glucose production in fasting healthy volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endogenous glucose production
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Region of Southern Denmark

Investigators

  • Principal Investigator: Mette Marie H Christensen, MD, Department of Public Health, Clinical Pharmacology, University of Southen Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKF 379

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pharmacogenetics of Metformin

Clinical Trials on Metformin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe