Skeletal Muscles, Myokines and Glucose Metabolism MYOGLU

Hyperglycemia Clinical Trial

— MyoGlu  

Official title:

Skeletal Muscles, Myokines and Glucose Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803568
• Other study ID #: 2011/882
• Status: Completed
• Phase: N/A
• First received: February 26, 2013
• Last updated: March 1, 2013
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperglycemia
• Myokine
• Normoglycemia

Intervention

Other:
• Exercise
12 weeks of exercise; 4 times pr week

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian School of Sport Sciences, University of Oslo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in gene expression changes in skeletal and adipose tissue		Baseline and after 12 weeks, and before, 0 hr and 2 hours after acute exercise	No
Primary	Changes from baseline in plasma/serum levels of selected proteins		Baseline and after 12 weeks, and before, 0 hr and 2 hour	No
Secondary	Change from baseline in insulin sensitivity	Insulin sensitivity will be measured using the euglycaemic hyperinsulinaemic clamp technique.	Before and after 12 weeks of exercise	No
Secondary	Changes in baseline from maximal oxygen uptake VO2 max		Before and after 12 weeks	No
Secondary	Changes from baseline in muscle strength		Before and after 12 weeks	No
Secondary	Changes from baseline in body composition	Body composition will be estimated with whole body MRI.	Before and after 12 weeks	No
Secondary	Changes from baseline in heart frequency		Before and after 12 weeks	No

External Links

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