Study of Metformin Pharmacogenetics in Twins

December 2, 2014 updated by: Tore B. Stage, University of Southern Denmark

The Relation Between Heritability and the Trough Concentration of Metformin in Plasma Under Steady-state in Twins

The trough concentration of metformin will be examined in monozygotic and dizygotic twins. Current twin study will determine the total weight of genetics on the trough concentration of metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

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 C, Denmark, 5000
        • Clinical Pharmacology

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-40 years
  • Both twins has to be included
  • Dizygotic twin pairs has to be same sex
  • Informed consent given
  • Healthy condition

Exclusion Criteria:

  • Chronical/daily alcohol abuse
  • Hypersensitivity to metformin
  • Ingestion of drugs containing topiramate or x-ray contrast fluids
  • For women: Positive pregnancy test/breastfeeding at the beginning of the trial. No use of safe anticonceptives

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin
6 days treatment with metformin
Drug: Metformin
6 days treatment with metformin to steady-state

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heritability
Time Frame: After 6 days of metformin treatment
The trough concentrations of metformin in twin pairs will be used to determine the effect of heritability on metformin trough concentrations. This will give insight to the weight that genetic factors have on metformin pharmacokinetics at steady-state.
After 6 days of metformin treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single nucleotide polymorphisms (SNPs)
Time Frame: After 6 days treatment with metformin
The effect of SNPs on trough metformin concentration
After 6 days treatment with metformin

Collaborators and Investigators

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

Sponsor

University of Southern Denmark

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

April 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

May 31, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKF-383
  • 2012-005179-15 (EudraCT Number)

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.

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