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Completed

NCT Number: NCT01869621

Study of Metformin Pharmacogenetics 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology

Odense C, 5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

6 days treatment with metformin to steady-state

Primary outcomes

  1. 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.

Secondary outcomes

  1. Single nucleotide polymorphisms (SNPs)

    Time frame: After 6 days treatment with metformin

    The effect of SNPs on trough metformin concentration

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 5, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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