The Interaction Between Metformin and Acute Exercise

Kristian Karstoft

Status

Completed

Conditions

Impaired Glucose Tolerance

Diabetes Mellitus, Type 2

Treatments

Drug: Metformin treatment

Drug: Placebo treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03329651

H-17012307-1

Details and patient eligibility

About

Physical activity is a first line treatment for patients with type 2 diabetes (T2D), however, the vast majority of patients with T2D do not achieve satisfying glycemic control with physical activity alone, which is why pharmacological treatment with metformin is most often initiated.

It is known that metformin and exercise both activates 5' adenosine monophosphate-activated protein kinase (AMPK) in skeletal muscle and liver, and the activation of AMPK results in many different metabolic effects, including improvements in glycemic control. Because of this similarity in mechanism of action, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. Thus, the aim of this study is to assess the effects of acute physical activity with and without concomitant metformin treatment, in order to investigate whether an interaction between the two occur.

Subjects with impaired glucose tolerance will be randomized (1:1) to metformin/placebo treatment in a double-blinded way. Following a treatment run-in period of 17 days, two experimental days (one with acute exercise and one without acute exercise), separated by one week, will be performed in each subject.

This registration concerns a sub-study of another study which has previously been registrered at ClinicalTrials.gov (Unique Protocol ID: H-17012307). The specific outcomes in this registration have not previously been registered.

Enrollment

34 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Glucose-lowering-medication naïve T2D and/or subjects with impaired glucose tolerance defined as: 2-h plasma glucose (PG) in the 75-g OGTT (7.8-11.0 mmol/L) and/or HbA1c (39-47 mmol/mol)
Caucasian
BMI > 25 but < 40 kg/m2
Low to moderate physically active (≤90 min of structured physical activity/week)

Exclusion criteria

Pregnancy
Smoking
Glucose-lowering treatment
Treatment with steroids and other immunomodulating drugs
Contraindication to increased levels of physical activity
Liver disease (ALAT elevated more than 3 times above upper normal limit, or reduced levels of the liver function markers albumin and KF II+VII+X)
Renal insufficiency (eGFR<60 ml/min)
Prior history of lactic acidosis
HbA1c >55 mmol/mol and/or 2-hPG in the 75-g OGTT > 15 mmol/L