Skeletal Muscles, Myokines and Glucose Metabolism MYOGLU (MyoGlu)

This study has been completed.
Sponsor:
Collaborators:
University of Oslo
Norwegian School of Sport Sciences
Information provided by (Responsible Party):
Kåre Inge Birkeland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01803568
First received: February 26, 2013
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Hyperglycemia
Normoglycemia
Myokine
Other: Exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Skeletal Muscles, Myokines and Glucose Metabolism

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Changes from baseline in plasma/serum levels of selected proteins [ Time Frame: Baseline and after 12 weeks, and before, 0 hr and 2 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in insulin sensitivity [ Time Frame: Before and after 12 weeks of exercise ] [ Designated as safety issue: No ]
    Insulin sensitivity will be measured using the euglycaemic hyperinsulinaemic clamp technique.

  • Changes in baseline from maximal oxygen uptake VO2 max [ Time Frame: Before and after 12 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in muscle strength [ Time Frame: Before and after 12 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in body composition [ Time Frame: Before and after 12 weeks ] [ Designated as safety issue: No ]
    Body composition will be estimated with whole body MRI.

  • Changes from baseline in heart frequency [ Time Frame: Before and after 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise in normoglycaemic individuals Other: Exercise
12 weeks of exercise; 4 times pr week
Experimental: Exercise in hyperglycaemic individuals Other: Exercise
12 weeks of exercise; 4 times pr week

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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:

  1. Subjects having type 1 diabetes or medically treated type 2 diabetes.
  2. Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 90 mmHg at screening
  3. Significant hematological or renal disease or chronic renal impairment, GFR< 50 ml/min.
  4. Significant liver disease or ALAT >3x UNL.
  5. Chronic inflammatory disease in active phase or long-term use of corticosteroids last 3 months.
  6. Use of anti-diabetic agents, lipid lowering drugs, antihypertensive medication, ASA or any other drug not deemed suitable by the study physician.
  7. 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.
  8. BMI outside inclusion criteria.
  9. Smoker
  10. 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
  11. Exercising regularly (>1 times pr week)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803568

Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Norwegian School of Sport Sciences
Investigators
Principal Investigator: Kåre I Birkeland, MD PhD Oslo University Hospital
Study Chair: Christian A Drevon, MD PhD University of Oslo
  More Information

Additional Information:
No publications provided

Responsible Party: Kåre Inge Birkeland, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01803568     History of Changes
Other Study ID Numbers: 2011/882
Study First Received: February 26, 2013
Last Updated: March 1, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
Myokine
Insulin sensitivity
Exercise
Skeletal muscle

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 23, 2014