Impaired Glucose ToleranceNCT03329651
The Interaction Between Metformin and Acute Exercise
A study testing Metformin treatment in people with Impaired Glucose Tolerance and Diabetes Mellitus, Type 2, run by Kristian Karstoft at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Glucose Tolerance, Diabetes Mellitus, Type 2
- What is being tested?
- Metformin treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Nov 2017to 1 Oct 2018
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Glucose-lowering-medication naïve T2D and/or subjects with impaired glucose tolerance defined as: 2-h plasma glucose (PG) in the 75-g OGTT (7.8-11.0 mmol/L) and/or HbA1c (39-47 mmol/mol)
- Caucasian
- BMI > 25 but < 40 kg/m2
- Low to moderate physically active (≤90 min of structured physical activity/week)
Who cannot join
- Pregnancy
- Smoking
- Glucose-lowering treatment
- Treatment with steroids and other immunomodulating drugs
- Contraindication to increased levels of physical activity
- Liver disease (ALAT elevated more than 3 times above upper normal limit, or reduced levels of the liver function markers albumin and KF II+VII+X)
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- Renal insufficiency (eGFR<60 ml/min)
- Prior history of lactic acidosis
- HbA1c >55 mmol/mol and/or 2-hPG in the 75-g OGTT > 15 mmol/L
Trial locations and contacts
1 site in 1 country.
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 5' adenosine monophosphate-activated protein kinase (AMPK) in skeletal muscle and liver, and the activation of AMPK results in many different metabolic effects, including improvements in glycemic control. Because of this similarity in mechanism of action, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. Thus, the aim of this study is to assess the effects of acute physical activity with and without concomitant metformin treatment, in order to investigate whether an interaction between the two occur.
Read more
Subjects with impaired glucose tolerance will be randomized (1:1) to metformin/placebo treatment in a double-blinded way. Following a treatment run-in period of 17 days, two experimental days (one with acute exercise and one without acute exercise), separated by one week, will be performed in each subject.
This registration concerns a sub-study of another study which has previously been registrered at ClinicalTrials.gov (Unique Protocol ID: H-17012307). The specific outcomes in this registration have not previously been registered.
- Being tested
- Metformin treatment, Placebo treatment
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin treatmentDrug
Daily treatment with metformin tablets for 24 days according to the following scheme:
Day 1-4: Metformin tablet 500 mg x 2 Day 5-8: Metformin tablet 1000 + 500 mg Day 9-24: Metformin tablet 1000 mg x 2
Placebo treatmentDrug
Daily treatment with placebo tablets for 24 days according to the following scheme:
Day 1-4: Placebo tablet 500 mg x 2 Day 5-8: Placebo tablet 1000 + 500 mg Day 9-24: Placebo tablet 1000 mg x 2
| Study group | Role | What they receive |
|---|---|---|
| Metformin treatment | Experimental | Not described Receives: Drug: Metformin treatment |
| Placebo treatment | Placebo comparator | Not described Receives: Drug: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in postprandial glycemic control as assessed by mean blood glucose concentration during a 4 hour mixed-meal tolerance test
Measured: Day 17 (no acute exercise [control day]) and 24 (following an acute exercise bout)
Secondary outcomes (3)
Difference in endogenous glucose production as assessed by rate of infused glucose tracer appearance in blood
Measured: Day 17 (no acute exercise [control day]) and 24 (following an acute exercise bout)
Difference in exogenous glucose uptake as assessed by rate of ingested glucose tracer appearance in blood
Measured: Day 17 (no acute exercise [control day]) and 24 (following an acute exercise bout)
Difference in peripheral glucose uptake as assessed by rate of glucose disappearance from blood
Measured: Day 17 (no acute exercise [control day]) and 24 (following an acute exercise bout)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start10 Nov 2017
- Primary completion1 Jul 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristian Karstoft
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor-investigator, Kristian Karstoft, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kristian Karstoft, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329651
- Sponsor's protocol ID
- H-17012307-1
- Status last verified
- Nov 2018
- First submitted
- 30 Oct 2017
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interaction Between Metformin and Acute Exercise
- ClinicalTrials.gov ID
- NCT03329651
- Acronym / sponsor ID
- H-17012307-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kristian KarstoftUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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.
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 5' adenosine monophosphate-activated protein kinase (AMPK) in skeletal muscle and liver, and the activation of AMPK results in many different metabolic effects, including improvements in glycemic control. Because of this similarity in mechanism of action, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. Thus, the aim of this study is to assess the effects of acute physical activity with and without concomitant metformin treatment, in order to investigate whether an interaction between the two occur.
Subjects with impaired glucose tolerance will be randomized (1:1) to metformin/placebo treatment in a double-blinded way. Following a treatment run-in period of 17 days, two experimental days (one with acute exercise and one without acute exercise), separated by one week, will be performed in each subject.
This registration concerns a sub-study of another study which has previously been registrered at ClinicalTrials.gov (Unique Protocol ID: H-17012307). The specific outcomes in this registration have not previously been registered.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin treatment | Experimental | Drug: Metformin treatment |
| Placebo treatment | Placebo comparator | Drug: Placebo treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Glucose-lowering-medication naïve T2D and/or subjects with impaired glucose tolerance defined as: 2-h plasma glucose (PG) in the 75-g OGTT (7.8-11.0 mmol/L) and/or HbA1c (39-47 mmol/mol)
- Caucasian
- BMI > 25 but < 40 kg/m2
- Low to moderate physically active (≤90 min of structured physical activity/week)
Key exclusion criteria (9 listed)
- Pregnancy
- Smoking
- Glucose-lowering treatment
- Treatment with steroids and other immunomodulating drugs
- Contraindication to increased levels of physical activity
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 |
|---|---|---|
| Metformin treatmentDaily treatment with metformin tablets for 24 days according to the following scheme: Day 1-4: Metformin tablet 500 mg x 2 Day 5-8: Metformin tablet 1000 + 500 mg Day 9-24: Metformin tablet 1000 mg x 2 | Drug | Metformin treatment |
| Placebo treatmentDaily treatment with placebo tablets for 24 days according to the following scheme: Day 1-4: Placebo tablet 500 mg x 2 Day 5-8: Placebo tablet 1000 + 500 mg Day 9-24: Placebo tablet 1000 mg x 2 | Drug | Placebo treatment |
Primary outcome
Difference in postprandial glycemic control as assessed by mean blood glucose concentration during a 4 hour mixed-meal tolerance test
Time frame: Day 17 (no acute exercise [control day]) and 24 (following an acute exercise bout)
3 secondary outcomes
Difference in endogenous glucose production as assessed by rate of infused glucose tracer appearance in blood
Time frame: Day 17 (no acute exercise [control day]) and 24 (following an acute exercise bout)
Difference in exogenous glucose uptake as assessed by rate of ingested glucose tracer appearance in blood
Time frame: Day 17 (no acute exercise [control day]) and 24 (following an acute exercise bout)
Difference in peripheral glucose uptake as assessed by rate of glucose disappearance from blood
Time frame: Day 17 (no acute exercise [control day]) and 24 (following an acute exercise bout)
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 9 Nov 2018.
- 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
Copenhagen University Hospital, 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 treatment in people with Impaired Glucose Tolerance and Diabetes Mellitus, Type 2, run by Kristian Karstoft 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 4 inclusion and 9 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 9 Nov 2018. 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?
Difference in postprandial glycemic control as assessed by mean blood glucose concentration during a 4 hour mixed-meal tolerance test (time frame: Day 17 (no acute exercise [control day]) and 24 (following an acute exercise bout)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2018.