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Completed

NCT Number: NCT01803568

Skeletal Muscles, Myokines and Glucose Metabolism MYOGLU

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.

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Key information

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Other

12 weeks of exercise; 4 times pr week

Primary outcomes

  1. 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

  2. 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 outcomes

  1. Change from baseline in insulin sensitivity

    Time frame: Before and after 12 weeks of exercise

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

  2. Changes in baseline from maximal oxygen uptake VO2 max

    Time frame: Before and after 12 weeks

  3. Changes from baseline in muscle strength

    Time frame: Before and after 12 weeks

  4. Changes from baseline in body composition

    Time frame: Before and after 12 weeks

    Body composition will be estimated with whole body MRI.

  5. Changes from baseline in heart frequency

    Time frame: Before and after 12 weeks

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian School of Sport Sciences
  • University of Oslo

Registry information

Official study title

Skeletal Muscles, Myokines and Glucose Metabolism

Acronym: MyoGlu

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 4, 2013
Registry last updated
Mar 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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