NCT01869621CompletedPhase 1
The Relation Between Heritability and the Trough Concentration of Metformin in Plasma Under Steady-state in Twins
University of Southern Denmark1 site in 1 country34 target enrollmentStarted: April 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Heritability
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Metformin
Experimental
6 days treatment with metformin
Intervention: Metformin (Drug)
Outcomes
Primary Outcomes
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
- Single nucleotide polymorphisms (SNPs)(After 6 days treatment with metformin)
Investigators
Tore B. Stage
MSc Pharm
University of Southern Denmark
Study Sites (1)
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