Diabetes Mellitus, Type 2NCT02951260
The Effects of Metformin on Self-selected Exercise Intensity, Physical Fitness and Exercise-induced AMPK-activation
A study testing Metformin in people with Diabetes Mellitus, Type 2, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- HbA1c < 39 mmol/l
- BMI < 25
- structured physical activity < = 150 min/week
- apparently healthy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Metformin, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
17 days treatment with metformin
PlaceboOther
17 days treatment with placebo
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | 17 days metformin treatment Receives: Drug: Metformin |
| Placebo | Placebo comparator | 17 days placebo treatment Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall aerobic work performed during an exercise bout with self-selected intensity
Measured: Total oxygen consumption (L O2) during a 45 min ergometer cycling bout with self-selected intensity
Secondary outcomes (6)
External work performed during an exercise bout with self-selected intensity
Measured: 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
Measured: 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
Measured: Mean blood lactate (mmol/l) during a 45 min ergometer cycling bout with fixed intensity
Heartrate during an exercise bout with fixed intensity
Measured: Mean heart rate (bpm) during a 45 min ergometer cycling bout with fixed intensity
Respiratory exchange ratio during an exercise bout with fixed intensity
Measured: Mean VCO2/VO2 during a 45 min ergometer cycling bout with fixed intensity
Physical fitness (VO2max)
Measured: maximal oxygen consumption (L/min) during a VO2 max test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Kristian Karstoft, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kristian Karstoft, MD, PhD, Principal investigator, Center for aktiv sundhed, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951260
- Sponsor's protocol ID
- H- 16032037
- Status last verified
- Sep 2017
- First submitted
- 27 Oct 2016
- Last updated
- 27 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34784247
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Metformin on Self-selected Exercise Intensity, Physical Fitness and Exercise-induced AMPK-activation
- ClinicalTrials.gov ID
- NCT02951260
- Acronym / sponsor ID
- H- 16032037
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin17 days metformin treatment |
| Placebo | Placebo comparator | Other: Placebo17 days placebo treatment |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- male
- HbA1c < 39 mmol/l
- BMI < 25
- structured physical activity < = 150 min/week
- apparently healthy
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin17 days treatment with metformin | Drug | Metformin |
| Placebo17 days treatment with placebo | Other | Placebo |
Primary outcome
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
6 secondary outcomes
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
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
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
Heartrate during an exercise bout with fixed intensity
Time frame: Mean heart rate (bpm) during a 45 min ergometer cycling bout with fixed intensity
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
Physical fitness (VO2max)
Time frame: maximal oxygen consumption (L/min) during a VO2 max test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2017.
- Derived from this study: PubMed 34784247Pilmark 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian Karstoft, MD, PhD principal investigator
Center for aktiv sundhed, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Diabetes Mellitus, Type 2, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02951260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2017.