ExerciseNCT03203317
Myocellular Signalling in Skeletal Muscle
A study testing Insulin and Exercise in people with Exercise and Insulin Sensitivity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The study will investigate myocellular signalling in skeletal muscle after insulin-stimulation and exercise in healthy young men 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
- Exercise, Insulin Sensitivity
- What is being tested?
- Insulin and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2017to 26 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
- healthy
- informed consent
- habitual training (2-5 h/week)
- VO2max of 40-60 ml/min/kg
- lean mass 55-65 kg
Who cannot join
- smoker
- allergy towards insulin
- chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insulin-dependent and Exercise-induced Myocellular Signalling in Skeletal Muscle
The study will investigate myocellular signalling in skeletal muscle after insulin-stimulation and exercise in healthy young men
- Conditions
- Exercise, Insulin Sensitivity
- Being tested
- Insulin, Exercise
- Medical subject headings
- Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
2 h insulin clamp
ExerciseOther
Cycling exercise
| Study group | Role | What they receive |
|---|---|---|
| Insulin-stimulation | Experimental | 2 h insulin-clamp Receives: Drug: Insulin |
| Exercise | Experimental | 10 min of maximal exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle phospho-proteome signature
proteomic analysis of mixed muscle homogenate
Measured: Before and after 10 minutes of exercise, as well as before and after a 2 hour insulin stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 May 2017
- Primary completion26 Jul 2017
- Study completion26 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Nielsen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203317
- Sponsor's protocol ID
- TIN-X
- Status last verified
- Jul 2017
- First submitted
- 26 Apr 2017
- Last updated
- 1 Aug 2017
- 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 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin-dependent and Exercise-induced Myocellular Signalling in Skeletal Muscle
- ClinicalTrials.gov ID
- NCT03203317
- Acronym / sponsor ID
- TIN-X
- Conditions
- Exercise, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 26 Jul 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 29 Jun 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.
The study will investigate myocellular signalling in skeletal muscle after insulin-stimulation and exercise in healthy young men
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin-stimulation | Experimental | Drug: Insulin2 h insulin-clamp |
| Exercise | Experimental | Other: Exercise10 min of maximal exercise |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy
- informed consent
- habitual training (2-5 h/week)
- VO2max of 40-60 ml/min/kg
- lean mass 55-65 kg
Key exclusion criteria (3 listed)
- smoker
- allergy towards insulin
- chronic disease
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 |
|---|---|---|
| Insulin2 h insulin clamp | Drug | Insulin-stimulation |
| ExerciseCycling exercise | Other | Exercise |
Primary outcome
Change in muscle phospho-proteome signature
Time frame: Before and after 10 minutes of exercise, as well as before and after a 2 hour insulin stimulation
proteomic analysis of mixed muscle homogenate
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 1 Aug 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin and Exercise in people with Exercise and Insulin Sensitivity, run by University of Copenhagen 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 3 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 1 Aug 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. 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?
Change in muscle phospho-proteome signature (time frame: Before and after 10 minutes of exercise, as well as before and after a 2 hour insulin stimulation). 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 1 Aug 2017.