Insulin SensitivityNCT06776094
Physical Activity and Insulin Sensitivity Dynamics
A study testing One-legged-knee extensor exercise, Insulin infusion and Muscle Biopsy Medication: Lidocaine in people with Insulin Sensitivity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The study investigates the role of one single bout of exercise in mediating enhancement of muscle insulin sensitivity following a single bout of exercise. Furthermore, the study is aiming to elucidate the temporal development in insulin signaling, at the early timepoints of insulin stimulation that may be responsible… Read more about this study
- Who is it for?
- Ages 22 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- One-legged-knee extensor exercise, Insulin infusion and Muscle Biopsy Medication: Lidocaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 5 May 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals (no known diseases)
- No use of medication
- Non-smokers
- Male
- Aged 22-35 years
- Fitness level (VO2max, i.e., maximal oxygen uptake) between 30-50 mL O2/min/kg
- BMI between 28 and 35
Who cannot join
- Women
- Failure to meet all inclusion criteria
- Physical activity level (e.g., running, cycling, fitness, etc.) exceeding 6 hours per week
- Acute illness within 2 weeks prior to the study days
- Use of recreational drugs within 2 weeks prior to the study days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
University of Copenhagen, August Krogh Section for Human and Molecular Physiology
Copenhagen, 2100
Jørgen FP Wojtaszewski, Professor, +4535321625, jw@nexs.ku.dk
About this study
Official title: The Significance of Physical Activity for Insulin Signaling Dynamics and Insulin Sensitivity
The study investigates the role of one single bout of exercise in mediating enhancement of muscle insulin sensitivity following a single bout of exercise. Furthermore, the study is aiming to elucidate the temporal development in insulin signaling, at the early timepoints of insulin stimulation that may be responsible for the enhanced muscle insulin sensitivity.
This will be investigated in young healthy males subjected to a one-legged knee-extensor exercise followed by a hyperinsulinemic-euglycemic clamp, a setup known to enhance muscle insulin sensitivity.
Read the detailed description
The participant arrives fasting at 8:00 AM, having abstained from alcohol, nicotine, and caffeine for the past 24 hours and refrained from strenuous physical activity for the past 48 hours. The participants are then subjected to a one-legged knee extension exercise performed by the participant from 9:00 AM to 10:00 AM.
Groin catheters are inserted into the femoral artery and vein using ultrasound guidance and sterile technique
Two hours after the completion of the exercise, a catheter is inserted into an arm vein (antecubital vein) and groin catheters are inserted into the femoral artery and vein using ultrasound guidance and sterile technique. Four hours after the exercise ends, a hyperinsulinemic-euglycemic clamp is commenced. The clamp begins with a bolus injection of insulin, followed by a continuous infusion. Glucose is infused concurrently to maintain constant blood glucose levels.
Throughout the procedure, blood samples are collected every 5 minutes from the femoral catheters, and blood flow is measured using ultrasound Doppler. Muscle biopsies from the vastus lateralis of both legs are taken before the clamp starts and at 3, 6, 10, and 20 minutes after the clamp's initiation. Following the 20-minute mark, the clamp continues until steady-state is achieved to determine tissue-specific and whole-body insulin sensitivity.
Over the course of the experiment, a total of 10 muscle biopsies and approximately 150 mL of blood are collected. The experimental part of the study is expected to conclude by 4:30 PM. Participants are provided with food and beverages and observed for 1 hour before being allowed to leave the research laboratory.
- Conditions
- Insulin Sensitivity
- Being tested
- One-legged-knee extensor exercise, Insulin infusion, Muscle Biopsy Medication: Lidocaine, Exercise
- Keywords
- Exercise, Muscle insulin sensitivity, Muscle glucose uptake, GLUT4, Phosphoproteomics
- Medical subject headings
- Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-legged-knee extensor exerciseOther
1 hour of one-legged-knee-extensor exercise followed by 4 hours of rest
Insulin infusionProcedure or surgery
The hyperinsulinemic-euglycemic clamp is a well-established and recognized method for determining glucose uptake at a specific insulin infusion rate. It is a technique with which we have 25 years of uncomplicated experience. During the clamp, insulin (human recombinant insulin) is infused (1.42 mU/kg/min) into an arm vein (antecubital vein), while glucose (20% solution) is administered in an amount adjusted to maintain blood glucose (plasma glucose concentration) at basal levels.
The amount of insulin administered raises the participant's plasma insulin concentration (blood concentration) to approximately 100 μU/mL, which is considered within the physiological range. Blood samples are collected and analyzed continuously for glucose content, allowing for the determination of glucose uptake at the whole-body level and across the legs.
Later, these blood samples will also be analyzed for relevant metabolites and proteins, including insulin, to assess the metabolism of these substances.
Muscle Biopsy Medication: LidocaineProcedure or surgery
During supine rest, the skin on the outer thigh, approximately 15 cm above the knee, is disinfected with chlorhexidine alcohol. Subsequently, 3-4 mL of local anesthetic (lidocaine 20 mg/mL) is administered into the skin, subcutaneous tissue, and the upper portion of the muscle using a very thin needle. A pinprick test is performed after a few minutes to ensure the anesthetic is effective.
A small incision is then made in the skin and subcutaneous tissue to allow the biopsy needle to pass through to the muscle. Using the biopsy needle, a small sample of muscle tissue (approximately 150 mg) is collected. This may cause some discomfort but is very brief (~1-2 seconds). The needle is removed, a sterile dressing is applied, and the participant can leave the facility after completing the study.
The biopsy may result in mild muscle soreness for 2-3 days, similar to a minor muscle bruise. Regular physical activities can be resumed after the biopsy. However, it is advised to avoid swimming.
ExerciseOther
The participants' maximal oxygen uptake is determined through a test on a cycle ergometer before the start of the experiment. The test begins with a 20-minute warm-up at two different low workloads, after which the workload is gradually increased until the predetermined cadence can no longer be maintained, or the participant indicates exhaustion. During the test, the participant's exhaled air is collected. After completing the warm-up, it typically takes between 4 and 7 minutes to complete the test.
| Study group | Role | What they receive |
|---|---|---|
| Post-exercise insulin sensitivity | Experimental | Young healthy males will perform a single bout of knee-extensor exercise and insulin action is investigated 4 hours after cessation of exercise. Insulin action towards muscle glucose uptake will be investigated during a 120 min euglycemic hyperinsulinemic clamp. Receives: Other: One-legged-knee extensor exercise; Procedure: Insulin infusion; Procedure: Muscle Biopsy Medication: Lidocaine; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin stimulated muscle glucose uptake
Muscle glucose uptake during insulin stimulation in recovery from exercise (insulin sensitivity) will be determined based on Fick's principle. Thus, femoral arterio-venous difference (av difference) in blood glucose concentration will be multiplied by femoral arterial leg blood flow.
Measured: Through study completion, approx. 1 year.
Secondary outcomes (1)
Posttranslational modification of proteins in muscle biopsies
The obtained muscle samples will be subjected to mass spectrometry-based phosphoproteomic analysis. This measurement shows posttranslational modification that regulates protein function and will reveal the signalling network underlying the interventions studied. Unit of measure is log2-transformed arbitrary units
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start5 May 2025
- Primary completion26 Aug 2025
- Study completionJan 2027 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorgen FP Wojtaszewski, University of Copenhagen
- Investigators
- Jørgen FP Wojtaszewski, Prodessor, Principal investigator, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776094
- Sponsor's protocol ID
- TEMPO
- Status last verified
- Dec 2025
- First submitted
- 9 Jan 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Physical Activity for Insulin Signaling Dynamics and Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT06776094
- Acronym / sponsor ID
- TEMPO
- Conditions
- Insulin Sensitivity
- Keywords
- Exercise, Muscle insulin sensitivity, Muscle glucose uptake, GLUT4, Phosphoproteomics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Jan 2025 (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 role of one single bout of exercise in mediating enhancement of muscle insulin sensitivity following a single bout of exercise. Furthermore, the study is aiming to elucidate the temporal development in insulin signaling, at the early timepoints of insulin stimulation that may be responsible for the enhanced muscle insulin sensitivity.
This will be investigated in young healthy males subjected to a one-legged knee-extensor exercise followed by a hyperinsulinemic-euglycemic clamp, a setup known to enhance muscle insulin sensitivity.
Detailed description
The participant arrives fasting at 8:00 AM, having abstained from alcohol, nicotine, and caffeine for the past 24 hours and refrained from strenuous physical activity for the past 48 hours. The participants are then subjected to a one-legged knee extension exercise performed by the participant from 9:00 AM to 10:00 AM.
Groin catheters are inserted into the femoral artery and vein using ultrasound guidance and sterile technique
Two hours after the completion of the exercise, a catheter is inserted into an arm vein (antecubital vein) and groin catheters are inserted into the femoral artery and vein using ultrasound guidance and sterile technique. Four hours after the exercise ends, a hyperinsulinemic-euglycemic clamp is commenced. The clamp begins with a bolus injection of insulin, followed by a continuous infusion. Glucose is infused concurrently to maintain constant blood glucose levels.
Throughout the procedure, blood samples are collected every 5 minutes from the femoral catheters, and blood flow is measured using ultrasound Doppler. Muscle biopsies from the vastus lateralis of both legs are taken before the clamp starts and at 3, 6, 10, and 20 minutes after the clamp's initiation. Following the 20-minute mark, the clamp continues until steady-state is achieved to determine tissue-specific and whole-body insulin sensitivity.
Over the course of the experiment, a total of 10 muscle biopsies and approximately 150 mL of blood are collected. The experimental part of the study is expected to conclude by 4:30 PM. Participants are provided with food and beverages and observed for 1 hour before being allowed to leave the research laboratory.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-exercise insulin sensitivity | Experimental | Other: One-legged-knee extensor exercise, Procedure: Insulin infusion, Procedure: Muscle Biopsy Medication: Lidocaine, Other: ExerciseYoung healthy males will perform a single bout of knee-extensor exercise and insulin action is investigated 4 hours after cessation of exercise. Insulin action towards muscle glucose uptake will be investigated during a 120 min euglycemic hyperinsulinemic clamp. |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy individuals (no known diseases)
- No use of medication
- Non-smokers
- Male
- Aged 22-35 years
Key exclusion criteria (5 listed)
- Women
- Failure to meet all inclusion criteria
- Physical activity level (e.g., running, cycling, fitness, etc.) exceeding 6 hours per week
- Acute illness within 2 weeks prior to the study days
- Use of recreational drugs within 2 weeks prior to the study days
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 |
|---|---|---|
| One-legged-knee extensor exercise1 hour of one-legged-knee-extensor exercise followed by 4 hours of rest | Other | Post-exercise insulin sensitivity |
| Insulin infusionThe hyperinsulinemic-euglycemic clamp is a well-established and recognized method for determining glucose uptake at a specific insulin infusion rate. It is a technique with which we have 25 years of uncomplicated experience. During the clamp, insulin (human recombinant insulin) is infused (1.42 mU/kg/min) into an arm vein (antecubital vein), while glucose (20% solution) is administered in an amount adjusted to maintain blood glucose (plasma glucose concentration) at basal levels. The amount of insulin administered raises the participant's plasma insulin concentration (blood concentration) to approximately 100 μU/mL, which is considered within the physiological range. Blood samples are collected and analyzed continuously for glucose content, allowing for the determination of glucose uptake at the whole-body level and across the legs. Later, these blood samples will also be analyzed for relevant metabolites and proteins, including insulin, to assess the metabolism of these substances. | Procedure or surgery | Post-exercise insulin sensitivity |
| Muscle Biopsy Medication: LidocaineDuring supine rest, the skin on the outer thigh, approximately 15 cm above the knee, is disinfected with chlorhexidine alcohol. Subsequently, 3-4 mL of local anesthetic (lidocaine 20 mg/mL) is administered into the skin, subcutaneous tissue, and the upper portion of the muscle using a very thin needle. A pinprick test is performed after a few minutes to ensure the anesthetic is effective. A small incision is then made in the skin and subcutaneous tissue to allow the biopsy needle to pass through to the muscle. Using the biopsy needle, a small sample of muscle tissue (approximately 150 mg) is collected. This may cause some discomfort but is very brief (~1-2 seconds). The needle is removed, a sterile dressing is applied, and the participant can leave the facility after completing the study. The biopsy may result in mild muscle soreness for 2-3 days, similar to a minor muscle bruise. Regular physical activities can be resumed after the biopsy. However, it is advised to avoid swimming. | Procedure or surgery | Post-exercise insulin sensitivity |
| ExerciseThe participants' maximal oxygen uptake is determined through a test on a cycle ergometer before the start of the experiment. The test begins with a 20-minute warm-up at two different low workloads, after which the workload is gradually increased until the predetermined cadence can no longer be maintained, or the participant indicates exhaustion. During the test, the participant's exhaled air is collected. After completing the warm-up, it typically takes between 4 and 7 minutes to complete the test. | Other | Post-exercise insulin sensitivity |
Primary outcome
Insulin stimulated muscle glucose uptake
Time frame: Through study completion, approx. 1 year.
Muscle glucose uptake during insulin stimulation in recovery from exercise (insulin sensitivity) will be determined based on Fick's principle. Thus, femoral arterio-venous difference (av difference) in blood glucose concentration will be multiplied by femoral arterial leg blood flow.
1 secondary outcome
Posttranslational modification of proteins in muscle biopsies
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Jørgen FP Wojtaszewski, Prodessor principal investigator
Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-legged-knee extensor exercise, Insulin infusion and Muscle Biopsy Medication: Lidocaine 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jørgen FP Wojtaszewski, Professor (+4535321625, jw@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin stimulated muscle glucose uptake (time frame: Through study completion, approx. 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 2 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.