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Skeletal Muscles, Myokines and Glucose Metabolism MYOGLU (MyoGlu)

Primary Purpose

Hyperglycemia, Normoglycemia, Myokine

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional basic science trial for Hyperglycemia focused on measuring Myokine, Insulin sensitivity, Exercise, Skeletal muscle

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Male
Age 40-65 years
Nordic ethnicity
Non-smoker
1. Either (participants with impaired glucose metabolism): Body Mass Index (BMI) 27-32 kg/m2 and abnormal glucose metabolism, defined as:
  i. 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%)
2. Or (controls): BMI 19-25 kg/m2 and normal glucose metabolism and no first degree relatives with type 2 diabetes.

Exclusion Criteria:

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.
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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Exercise in normoglycaemic individuals

Exercise in hyperglycaemic individuals

Arm Description

Outcomes

Primary Outcome Measures

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

Changes from baseline in plasma/serum levels of selected proteins

Secondary Outcome Measures

Change from baseline in insulin sensitivity

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

Changes in baseline from maximal oxygen uptake VO2 max

Changes from baseline in muscle strength

Changes from baseline in body composition

Body composition will be estimated with whole body MRI.

Changes from baseline in heart frequency

Full Information

NCT ID

NCT01803568

First Posted

February 26, 2013

Last Updated

March 1, 2013

Sponsor

Oslo University Hospital

Collaborators

University of Oslo, Norwegian School of Sport Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01803568

Brief Title

Skeletal Muscles, Myokines and Glucose Metabolism MYOGLU

Acronym

MyoGlu

Official Title

Skeletal Muscles, Myokines and Glucose Metabolism

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

Collaborators

University of Oslo, Norwegian School of Sport Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperglycemia, Normoglycemia, Myokine

Keywords

Myokine, Insulin sensitivity, Exercise, Skeletal muscle

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise in normoglycaemic individuals

Arm Type

Experimental

Arm Title

Exercise in hyperglycaemic individuals

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

12 weeks of exercise; 4 times pr week

Primary Outcome Measure Information:

Title

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

Title

Changes from baseline in plasma/serum levels of selected proteins

Time Frame

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

Secondary Outcome Measure Information:

Title

Change from baseline in insulin sensitivity

Description

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

Time Frame

Before and after 12 weeks of exercise

Title

Changes in baseline from maximal oxygen uptake VO2 max

Time Frame

Before and after 12 weeks

Title

Changes from baseline in muscle strength

Time Frame

Before and after 12 weeks

Title

Changes from baseline in body composition

Description

Body composition will be estimated with whole body MRI.

Time Frame

Before and after 12 weeks

Title

Changes from baseline in heart frequency

Time Frame

Before and after 12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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: i. 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. Exclusion Criteria: 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. 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kåre I Birkeland, MD PhD

Organizational Affiliation

Oslo University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christian A Drevon, MD PhD

Organizational Affiliation

University of Oslo

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

30591411

Citation

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.

Results Reference

derived

PubMed Identifier

29695812

Citation

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. Erratum In: Sci Rep. 2018 May 15;8(1):7885.

Results Reference

derived

PubMed Identifier

29300960

Citation

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.

Results Reference

derived

PubMed Identifier

27821717

Citation

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.

Results Reference

derived

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Skeletal Muscles, Myokines and Glucose Metabolism MYOGLU

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