Pharmacogenetics of Metformin
Conditions
Keywords
Metformin, Hypoglycemic Agents, Diabetes Mellitus, Type 2, Gluconeogenesis, Pharmacodynamics, Pharmacogenetics
Brief summary
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.
Interventions
DRUGMetformin
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.
Sponsors
Region of Southern Denmark
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers * Written consent * Genotyped in OCT1 for (M420del and R61C)
Exclusion criteria
* Daily medication * Alcohol abuse * Pregnancy * Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endogenous glucose production | 48 hours |
Countries
Denmark
Outcome results
None listed