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Completed

NCT Number: NCT02951260

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for aktiv sundhed

Copenhagen, Copenhagen N, 2200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

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

Treatment and study plan

metformin

Drug

17 days treatment with metformin

Placebo

Other

17 days treatment with placebo

Primary outcomes

  1. Overall aerobic work performed during an exercise bout with self-selected intensity

    Time frame: Total oxygen consumption (L O2) during a 45 min ergometer cycling bout with self-selected intensity

Secondary outcomes

  1. External work performed during an exercise bout with self-selected intensity

    Time frame: Total work produced (kJ) during a 45 min ergometer cycling bout with self-selected intensity

  2. Rate of perceived exertion during an exercise bout with fixed intensity

    Time frame: Mean rate of perceived exertion (Borg scale) during a 45 min ergometer cycling bout with fixed intensity

  3. blood lactate during an exercise bout with fixed intensity

    Time frame: Mean blood lactate (mmol/l) during a 45 min ergometer cycling bout with fixed intensity

  4. Heartrate during an exercise bout with fixed intensity

    Time frame: Mean heart rate (bpm) during a 45 min ergometer cycling bout with fixed intensity

  5. Respiratory exchange ratio during an exercise bout with fixed intensity

    Time frame: Mean VCO2/VO2 during a 45 min ergometer cycling bout with fixed intensity

  6. Physical fitness (VO2max)

    Time frame: maximal oxygen consumption (L/min) during a VO2 max test

Other outcomes

  1. AMPK-activation in skeletal muscle during an exercise bout with fixed intensity

    Time frame: change in exercise induced AMPK-activation after compared to before a 45 min ergometer cycling bout with self-selected intensity

  2. Oxidative phosphorylation in skeletal muscle fibers

    Time frame: Mitochondrial Complex I respiration in skeletal muscle tissue after 17 days of metformin/placebo treatment

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • University of Copenhagen

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2016
Registry last updated
Sep 27, 2017

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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