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

NCT ID: NCT02951260

Last Updated: 2017-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Metformin

17 days metformin treatment

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

17 days treatment with metformin

Placebo

17 days placebo treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

17 days treatment with placebo

Interventions

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Metformin

17 days treatment with metformin

Intervention Type DRUG

Placebo

17 days treatment with placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kristian Karstoft

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristian Karstoft, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for aktiv sundhed, Rigshospitalet

Locations

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Center for aktiv sundhed

Copenhagen, Copenhagen N, Denmark

Site Status

Countries

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Denmark

References

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Pilmark NS, Oberholzer L, Halling JF, Kristensen JM, Bonding CP, Elkjaer I, Lyngbaek M, Elster G, Siebenmann C, Holm NFR, Birk JB, Larsen EL, Lundby AM, Wojtaszewski J, Pilegaard H, Poulsen HE, Pedersen BK, Hansen KB, Karstoft K. Skeletal muscle adaptations to exercise are not influenced by metformin treatment in humans: secondary analyses of 2 randomized, clinical trials. Appl Physiol Nutr Metab. 2022 Mar;47(3):309-320. doi: 10.1139/apnm-2021-0194. Epub 2021 Nov 16.

Reference Type DERIVED
PMID: 34784247 (View on PubMed)

Other Identifiers

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H- 16032037

Identifier Type: -

Identifier Source: org_study_id