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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01803568
Other study ID # 2011/882
Secondary ID
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


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
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