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Clinical Trials/NCT02951260
NCT02951260
Completed
Not Applicable

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

Rigshospitalet, Denmark1 site in 1 country15 target enrollmentOctober 2016

Overview

Phase
Not Applicable
Intervention
Metformin
Conditions
Diabetes Mellitus, Type 2
Sponsor
Rigshospitalet, Denmark
Enrollment
15
Locations
1
Primary Endpoint
Overall aerobic work performed during an exercise bout with self-selected intensity
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
July 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kristian Karstoft

MD, PhD

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

Metformin

17 days metformin treatment

Intervention: Metformin

Placebo

17 days placebo treatment

Intervention: Placebo

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

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