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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy volunteers
Written consent
Genotyped in OCT1 for (M420del and R61C)

Exclusion criteria

Daily medication
Alcohol abuse
Pregnancy
Breastfeeding

Treatment and study plan

metformin

Drug

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.

Primary outcomes

Endogenous glucose production

Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

Region of Southern Denmark

Registry information

Official study title

The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1 (OCT1) in Healthy Volunteers

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Jul 22, 2011
Registry last updated: Jun 26, 2015

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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Completed