Insulin SensitivityNCT04872426
Ischemia-reperfusion Exercise Study
A study testing Exercise, insulin infusion in people with Insulin Sensitivity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The study investigates the relationship between activation of AMP-activated protein kinase (AMPK) in human skeletal muscle and the subsequent improvement in muscle insulin sensitivity for the stimulation of glucose uptake. This will be investigated in young healthy lean male subjects. Read more about this study
- Who is it for?
- Ages 25 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- Exercise, insulin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Aug 2018to 3 Jan 2020
- 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 25 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal weight (BMI: below or equal to 27)
- physical active on a regular basis
- cardiorespiratory fitness between 40-60 ml/kg/min
- no history or sign of type 2 diabetes, hypertension, insulin resistance or dyslipidemia
Who cannot join
- smoker
- BMI: above 27
- using any kind of medication
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Exercise, Nutrition and Sports, Faculty of Sciences, University of Copenhagen
Copenhagen, 2100
About this study
Official title: Effect of Ischemia on the Insulin-sensitizing Effect of Exercise
The study investigates the relationship between activation of AMP-activated protein kinase (AMPK) in human skeletal muscle and the subsequent improvement in muscle insulin sensitivity for the stimulation of glucose uptake.
This will be investigated in young healthy lean male subjects.
Read the detailed description
This study aims to demonstrate the association between AMPK activation and increased insulin sensitivity in human skeletal muscle. The investigators intend to examine insulin sensitivity after various levels of AMPK activation in skeletal muscle that includes exercise at different intensities as well as exercise combined with leg blood flow restriction (ischemia). The hypothesis is that exercise combined with ischemia will result in an increased activation of AMPK compared to exercise alone, and therefore it is expected that exercise combined with ischemia will result in the greatest improvement in muscle insulin sensitivity.
Methods:
The main experiment consists of 3 experimental days (A, B and C), separated by a minimum of 14 days and carried out in a randomised order. On all the study days, the participants will arrive in the laboratory after an overnight fast. Catheters will be placed in both femoral veins and in one femoral artery. A muscle biopsy will be obtained from vastus lateralis of one leg (resting leg). Experiment A consists of one-legged muscle work for 1 hour at 70% of the leg maximum aerobic work capacity with the other leg serving as a resting control. In experiment B, the same work are performed, but with periodic at the same constricting the blood supply to the working leg (25 seconds every 2 min). Experiment C consists of one-legged muscle work for 1 hour at 70% and 95% of the leg maximum aerobic work capacity (alternately every 5 min). Immediately after each type of exercise a biopsy will be obtained from the exercising leg and the participants will rest in the fasted state for 3 hours before a third set of muscle biopsies (from both legs) will be obtained. Subsequently, insulin sensitivity will be evaluated in the participants during a 2-hour physiological hyperinsulinemic euglycemic clamp. By the end of the clamp, a final set of biopsies (both legs) will be obtained. Throughout the study day sampling of artery and venous blood/plasma samples allows for the estimation of substrate extraction by the two legs. Further, measures of artery blood flow by Ultrasound Doppler technique allow for the final calculation of substrate uptake/release across the two legs before exercise, during exercise and in recovery from exercise. Importantly, the ability for insulin to stimulate these processes can be evaluated in both a rested and in a prior exercised leg.
- Conditions
- Insulin Sensitivity
- Being tested
- Exercise, insulin infusion
- Keywords
- Exercise, Glucose Uptake, Ischemia, Insulin Sensitivity
- Medical subject headings
- Insulin Resistance, Motor Activity, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise, insulin infusionOther
Acute one-legged exercise, Insulin infusion 3 hours after one-legged exercise
| Study group | Role | What they receive |
|---|---|---|
| Low intensity exercise | Experimental | 70% of maximal leg work load capacity Receives: Other: Exercise, insulin infusion |
| High intensity exercise | Experimental | 70% and 95% of maximal work load capacity (alternately every 5 min) Receives: Other: Exercise, insulin infusion |
| Low intensity exercise + intermittent ischemia-reperfusion | Experimental | 70% of maximal leg work load capacity with intermittent ischemia (25 seconds every 2 min) Receives: Other: Exercise, insulin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle glucose uptake during exercise and enhanced insulin sensitivity in recovery from exercise.
Leg glucose uptake is calculated by the arterial-venous difference i blood glucose concentration multiplied with leg blood flow. Sampling of artery and venous blood samples for blood glucose measurements. Measures of artery blood flow by Ultrasound Doppler technique allows a final calculation of glucose uptake across the legs before exercise, during exercise, in recovery from exercise and with insulin stimulation.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (2)
AMPK activity in muscle biopsies
The obtained muscle samples will be subjected to protein kinase activity measurements.
Measured: 5 years
Posttranslational modification of proteins in muscle biopsies
The obtained muscle samples will be subjected to standard western blotting for the evaluation of posttranslational modifications of various proteins involved in glucose metabolism.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start31 Aug 2018
- Primary completion3 Jan 2020
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Jorgen FP Wojtaszewski, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872426
- Sponsor's protocol ID
- Ischemia
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- 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 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ischemia on the Insulin-sensitizing Effect of Exercise
- ClinicalTrials.gov ID
- NCT04872426
- Acronym / sponsor ID
- Ischemia
- Conditions
- Insulin Sensitivity
- Keywords
- Exercise, Glucose Uptake, Ischemia, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 4 May 2021 (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 investigates the relationship between activation of AMP-activated protein kinase (AMPK) in human skeletal muscle and the subsequent improvement in muscle insulin sensitivity for the stimulation of glucose uptake.
This will be investigated in young healthy lean male subjects.
Detailed description
This study aims to demonstrate the association between AMPK activation and increased insulin sensitivity in human skeletal muscle. The investigators intend to examine insulin sensitivity after various levels of AMPK activation in skeletal muscle that includes exercise at different intensities as well as exercise combined with leg blood flow restriction (ischemia). The hypothesis is that exercise combined with ischemia will result in an increased activation of AMPK compared to exercise alone, and therefore it is expected that exercise combined with ischemia will result in the greatest improvement in muscle insulin sensitivity.
Methods:
The main experiment consists of 3 experimental days (A, B and C), separated by a minimum of 14 days and carried out in a randomised order. On all the study days, the participants will arrive in the laboratory after an overnight fast. Catheters will be placed in both femoral veins and in one femoral artery. A muscle biopsy will be obtained from vastus lateralis of one leg (resting leg). Experiment A consists of one-legged muscle work for 1 hour at 70% of the leg maximum aerobic work capacity with the other leg serving as a resting control. In experiment B, the same work are performed, but with periodic at the same constricting the blood supply to the working leg (25 seconds every 2 min). Experiment C consists of one-legged muscle work for 1 hour at 70% and 95% of the leg maximum aerobic work capacity (alternately every 5 min). Immediately after each type of exercise a biopsy will be obtained from the exercising leg and the participants will rest in the fasted state for 3 hours before a third set of muscle biopsies (from both legs) will be obtained. Subsequently, insulin sensitivity will be evaluated in the participants during a 2-hour physiological hyperinsulinemic euglycemic clamp. By the end of the clamp, a final set of biopsies (both legs) will be obtained. Throughout the study day sampling of artery and venous blood/plasma samples allows for the estimation of substrate extraction by the two legs. Further, measures of artery blood flow by Ultrasound Doppler technique allow for the final calculation of substrate uptake/release across the two legs before exercise, during exercise and in recovery from exercise. Importantly, the ability for insulin to stimulate these processes can be evaluated in both a rested and in a prior exercised leg.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low intensity exercise | Experimental | Other: Exercise, insulin infusion70% of maximal leg work load capacity |
| High intensity exercise | Experimental | Other: Exercise, insulin infusion70% and 95% of maximal work load capacity (alternately every 5 min) |
| Low intensity exercise + intermittent ischemia-reperfusion | Experimental | Other: Exercise, insulin infusion70% of maximal leg work load capacity with intermittent ischemia (25 seconds every 2 min) |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- normal weight (BMI: below or equal to 27)
- physical active on a regular basis
- cardiorespiratory fitness between 40-60 ml/kg/min
- no history or sign of type 2 diabetes, hypertension, insulin resistance or dyslipidemia
Key exclusion criteria (3 listed)
- smoker
- BMI: above 27
- using any kind of medication
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 |
|---|---|---|
| Exercise, insulin infusionAcute one-legged exercise, Insulin infusion 3 hours after one-legged exercise | Other | High intensity exercise, Low intensity exercise, Low intensity exercise + intermittent ischemia-reperfusion |
Primary outcome
Muscle glucose uptake during exercise and enhanced insulin sensitivity in recovery from exercise.
Time frame: Through study completion, an average of 1 year.
Leg glucose uptake is calculated by the arterial-venous difference i blood glucose concentration multiplied with leg blood flow. Sampling of artery and venous blood samples for blood glucose measurements. Measures of artery blood flow by Ultrasound Doppler technique allows a final calculation of glucose uptake across the legs before exercise, during exercise, in recovery from exercise and with insulin stimulation.
2 secondary outcomes
AMPK activity in muscle biopsies
Time frame: 5 years
Posttranslational modification of proteins in muscle biopsies
Time frame: 5 years
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 21 Jan 2022.
- 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 Exercise, insulin infusion in people with 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 4 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 21 Jan 2022. 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?
Muscle glucose uptake during exercise and enhanced insulin sensitivity in recovery from exercise. (time frame: Through study completion, an average of 1 year.). 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 21 Jan 2022.