The Effects of Metformin on Self-selected Exercise Intensity, Physical Fitness and Exercise-induced AMPK-activation

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Metformin; Other: Placebo

• Registration Number: NCT02951260
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

The purpose of this study is to evaluate the potential interaction between metformin and exercise in order to optimize clinical guidelines for treatment of T2D.

Detailed Description

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 AMPK, which results in many different metabolic effects. Because of this similarity, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. With this study the investigators aim to look at the individual and combined effects of metformin and exercise in order to investigate whether an interaction occur. An Interaction will have tremendous clinical importance for patients with T2D given current guidelines where the vast majority of these patients are recommended both exercise and metformin treatment.

The investigators hypothesize that metformin treatment reduces self-selected exercise intensity, which may be explained via decreased mitochondrial complex 1 function, increased blood lactate levels, heart rate and RPE during exercise. Furthermore exercise-induced AMPK-activation is reduced with metformin treatment.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-10-31
• Study First Posted: 2016-11-01
• Primary Completion: 2017-04
• Study Completion: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-26
• Last Update Posted: 2017-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• male
• HbA1c < 39 mmol/l
• BMI < 25
• structured physical activity < = 150 min/week
• apparently healthy

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Exclusion Criteria

• smoking
• daily pharmaceutical treatment
• contraindication to increased levels of physical activity
• ALAT/ASAT elevated 3 times above upper normal values
• renal insufficiency (eGFR < 60 ml/min)
• prior history of lactic acidosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	17 days metformin treatment
Placebo	Placebo	17 days placebo treatment

Primary Outcome Measures

Name	Time	Method
Overall aerobic work performed during an exercise bout with self-selected intensity	Total oxygen consumption (L O2) during a 45 min ergometer cycling bout with self-selected intensity

Secondary Outcome Measures

Name	Time	Method
Physical fitness (VO2max)	maximal oxygen consumption (L/min) during a VO2 max test
External work performed during an exercise bout with self-selected intensity	Total work produced (kJ) during a 45 min ergometer cycling bout with self-selected intensity
Rate of perceived exertion during an exercise bout with fixed intensity	Mean rate of perceived exertion (Borg scale) during a 45 min ergometer cycling bout with fixed intensity
blood lactate during an exercise bout with fixed intensity	Mean blood lactate (mmol/l) during a 45 min ergometer cycling bout with fixed intensity
Heartrate during an exercise bout with fixed intensity	Mean heart rate (bpm) during a 45 min ergometer cycling bout with fixed intensity
Respiratory exchange ratio during an exercise bout with fixed intensity	Mean VCO2/VO2 during a 45 min ergometer cycling bout with fixed intensity

Trial Locations

Locations (1)

Center for aktiv sundhed; 🇩🇰 Copenhagen, Copenhagen N, Denmark