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HyperglycemiaMyoGluNCT01803568

Skeletal Muscles, Myokines and Glucose Metabolism MYOGLU

A study testing Exercise in people with Hyperglycemia and Normoglycemia, run by Oslo University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Normal glucose uptake and metabolism in skeletal muscles are essential to keep blood glucose within normal range and hence, insulin resistance (possibly mediated by inflammatory processes) in skeletal muscle is a major pathogenic factor in type 2 diabetes. Read more about this study

Who is it for?
Ages 40 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Hyperglycemia, Normoglycemia, Myokine
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
No sites listed yet
Study dates
Sep 2011to Dec 2012
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 40 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male
  • Age 40-65 years
  • Nordic ethnicity
  • Non-smoker
  • Either (participants with impaired glucose metabolism): Body Mass Index (BMI) 27-32 kg/m2 and abnormal glucose metabolism, defined as:
  • impaired fasting glucose (FPG ≥ 5.6 mmol/L) ii. impaired glucose tolerance (2 h PG ≥7.8 mmol/L) iii. type 2 diabetes (no medication, HbA1c ≤7.5%)
  • Or (controls): BMI 19-25 kg/m2 and normal glucose metabolism and no first degree relatives with type 2 diabetes.

Who cannot join

  • Subjects having type 1 diabetes or medically treated type 2 diabetes.
  • Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 90 mmHg at screening
  • Significant hematological or renal disease or chronic renal impairment, GFR< 50 ml/min.
  • Significant liver disease or ALAT >3x UNL.
  • Chronic inflammatory disease in active phase or long-term use of corticosteroids last 3 months.
  • Use of anti-diabetic agents, lipid lowering drugs, antihypertensive medication, ASA or any other drug not deemed suitable by the study physician.
Show all 11Show fewer
  • Mental condition (psychiatric or organic cerebral disease), drug or alcohol abuse rendering the subject unable to understand the nature, scope and possible consequences of the study.
  • BMI outside inclusion criteria.
  • Smoker
  • Any medical or other condition that in the judgment of the investigator would jeopardize the subject's safety or evaluation of the intervention for efficacy and safety
  • Exercising regularly (>1 times pr week)

About this study

Official title: Skeletal Muscles, Myokines and Glucose Metabolism

Normal glucose uptake and metabolism in skeletal muscles are essential to keep blood glucose within normal range and hence, insulin resistance (possibly mediated by inflammatory processes) in skeletal muscle is a major pathogenic factor in type 2 diabetes. Physical activity seems to be of essential importance in the prevention and treatment of type 2 diabetes. Myokines are proteins secreted from skeletal muscle that can execute important biological functions locally in the muscle (paracrine) or in other organs like the brain, heart and pancreas (endocrine). Evidence suggest that several interleukines and other cytokines are secreted by skeletal muscles. In the present project, the investigators will explore the relation between secreted myokines from muscle cells, insulin resistance and glucose metabolism before and after 12 weeks of exercise intervention. Subjects with normal as well as impaired glucose metabolism will be included in the study.

Being tested
Exercise
Keywords
Myokine, Insulin sensitivity, Exercise, Skeletal muscle
Medical subject headings
Hyperglycemia, Insulin Resistance, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    12 weeks of exercise; 4 times pr week

Study groups in NCT01803568
Study groupRoleWhat they receive
Exercise in normoglycaemic individualsExperimentalNot described
Receives: Other: Exercise
Exercise in hyperglycaemic individualsExperimentalNot described
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in gene expression changes in skeletal and adipose tissue

    Measured: Baseline and after 12 weeks, and before, 0 hr and 2 hours after acute exercise

  2. Changes from baseline in plasma/serum levels of selected proteins

    Measured: Baseline and after 12 weeks, and before, 0 hr and 2 hour

Secondary outcomes (5)

  1. Change from baseline in insulin sensitivity

    Insulin sensitivity will be measured using the euglycaemic hyperinsulinaemic clamp technique.

    Measured: Before and after 12 weeks of exercise

  2. Changes in baseline from maximal oxygen uptake VO2 max

    Measured: Before and after 12 weeks

  3. Changes from baseline in muscle strength

    Measured: Before and after 12 weeks

  4. Changes from baseline in body composition

    Body composition will be estimated with whole body MRI.

    Measured: Before and after 12 weeks

  5. Changes from baseline in heart frequency

    Measured: Before and after 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2013 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01803568
Sponsor's protocol ID
2011/882
Acronym
MyoGlu
Status last verified
Mar 2013
First submitted
26 Feb 2013
Last updated
4 Mar 2013
Results posted
No
Data monitoring committee
No

Publications

  • Lee-Odegard S, Austin Argentieri M, Norheim F, Drevon CA, Birkeland KI. Reversal of proteomic aging with exercise-results from the UK biobank and a 12-week intervention study. NPJ Aging. 2025 Dec 26;12(1):19. doi: 10.1038/s41514-025-00318-w.

    PubMed 41449222

  • Lee-Odegard S, Hjorth M, Olsen T, Moen GH, Daubney E, Evans DM, Hevener AL, Lusis AJ, Zhou M, Seldin MM, Allayee H, Hilser J, Viken JK, Gulseth H, Norheim F, Drevon CA, Birkeland KI. Serum proteomic profiling of physical activity reveals CD300LG as a novel exerkine with a potential causal link to glucose homeostasis. Elife. 2024 Aug 27;13:RP96535. doi: 10.7554/eLife.96535.

    PubMed 39190027

  • Doncheva AI, Romero S, Ramirez-Garrastacho M, Lee S, Kolnes KJ, Tangen DS, Olsen T, Drevon CA, Llorente A, Dalen KT, Hjorth M. Extracellular vesicles and microRNAs are altered in response to exercise, insulin sensitivity and overweight. Acta Physiol (Oxf). 2022 Dec;236(4):e13862. doi: 10.1111/apha.13862. Epub 2022 Aug 10.

    PubMed 36377504

  • Moore TM, Zhou Z, Cohn W, Norheim F, Lin AJ, Kalajian N, Strumwasser AR, Cory K, Whitney K, Ho T, Ho T, Lee JL, Rucker DH, Shirihai O, van der Bliek AM, Whitelegge JP, Seldin MM, Lusis AJ, Lee S, Drevon CA, Mahata SK, Turcotte LP, Hevener AL. The impact of exercise on mitochondrial dynamics and the role of Drp1 in exercise performance and training adaptations in skeletal muscle. Mol Metab. 2019 Mar;21:51-67. doi: 10.1016/j.molmet.2018.11.012. Epub 2018 Dec 4.

    PubMed 30591411

  • Lee S, Norheim F, Gulseth HL, Langleite TM, Aker A, Gundersen TE, Holen T, Birkeland KI, Drevon CA. Skeletal muscle phosphatidylcholine and phosphatidylethanolamine respond to exercise and influence insulin sensitivity in men. Sci Rep. 2018 Apr 25;8(1):6531. doi: 10.1038/s41598-018-24976-x.

    PubMed 29695812

  • Sommer C, Lee S, Gulseth HL, Jensen J, Drevon CA, Birkeland KI. Soluble Leptin Receptor Predicts Insulin Sensitivity and Correlates With Upregulation of Metabolic Pathways in Men. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1024-1032. doi: 10.1210/jc.2017-02126.

    PubMed 29300960

  • Lee S, Norheim F, Langleite TM, Noreng HJ, Storas TH, Afman LA, Frost G, Bell JD, Thomas EL, Kolnes KJ, Tangen DS, Stadheim HK, Gilfillan GD, Gulseth HL, Birkeland KI, Jensen J, Drevon CA, Holen T; NutriTech Consortium. Effect of energy restriction and physical exercise intervention on phenotypic flexibility as examined by transcriptomics analyses of mRNA from adipose tissue and whole body magnetic resonance imaging. Physiol Rep. 2016 Nov;4(21):e13019. doi: 10.14814/phy2.13019.

    PubMed 27821717

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Hyperglycemia and Normoglycemia, run by Oslo University Hospital.

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 11 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 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

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 from baseline in gene expression changes in skeletal and adipose tissue (time frame: Baseline and after 12 weeks, and before, 0 hr and 2 hours after acute exercise). The study lists 2 primary outcomes in all. 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 NCT01803568, which also lists 7 linked publications.

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 4 Mar 2013.

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