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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951260
• Other study ID #: H- 16032037
• Status: Completed
• Phase: N/A
• First received: October 27, 2016
• Last updated: September 26, 2017
• Start date: October 2016
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Metformin
17 days treatment with metformin

Other:
• Placebo
17 days treatment with placebo

Locations

Country	Name	City	State
Denmark	Center for aktiv sundhed	Copenhagen	Copenhagen N

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AMPK-activation in skeletal muscle during an exercise bout with fixed intensity		change in exercise induced AMPK-activation after compared to before a 45 min ergometer cycling bout with self-selected intensity
Other	Oxidative phosphorylation in skeletal muscle fibers		Mitochondrial Complex I respiration in skeletal muscle tissue after 17 days of metformin/placebo treatment
Primary	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	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
Secondary	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
Secondary	blood lactate during an exercise bout with fixed intensity		Mean blood lactate (mmol/l) during a 45 min ergometer cycling bout with fixed intensity
Secondary	Heartrate during an exercise bout with fixed intensity		Mean heart rate (bpm) during a 45 min ergometer cycling bout with fixed intensity
Secondary	Respiratory exchange ratio during an exercise bout with fixed intensity		Mean VCO2/VO2 during a 45 min ergometer cycling bout with fixed intensity
Secondary	Physical fitness (VO2max)		maximal oxygen consumption (L/min) during a VO2 max test