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

University of Southern Denmark37 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Pharmacogenetics of Metformin

Interventions

MetforminDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers * Written consent * Genotyped in OCT1 for (M420del and R61C) Exclusion Criteria: * Daily medication * Alcohol abuse * Pregnancy * Breastfeeding

Locations (1)

Clinical pharmacology, Institute og public health, University of Southern Denmark

Odense, Denmark

Outcomes

Primary Outcomes

Endogenous glucose production

Time frame: 48 hours

Data from ClinicalTrials.gov

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