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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01316731
Other study ID # NL33968.081.10
Secondary ID
Status Completed
Phase N/A
First received March 10, 2011
Last updated December 20, 2011
Start date February 2011
Est. completion date June 2011

Study information

Verified date December 2011
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial Summary

Rationale: Proteins released from muscle during and shortly after exercise, often referred to as myokines, may be central to our understanding of the cross-talk during and after exercise between skeletal muscles and other organs, in particular the liver. So far only a few myokines are identified (e.g. IL-6, IL-8, IL-15, TNF-alpha). Taking into account the role of these several known myokines in developing insulin resistance, revealing new putative myokines might provide valuable information and a direction for future research on the pathogenesis and treatment of type 2 diabetes mellitus.

Objective: The objective of the present study is to identify novel myokines, expression of which is altered in skeletal muscle after a single bout of exercise.

Study design: experimental study. Study population: Ten healthy, male subjects between 40 and 60 years of age and BMI < 30 kg/m2, will participate in this study.

Intervention: A single exercise bout that consists of one hour one-legged cycling on a adapted recumbent cycle ergometer at a submaximal rate. The non-exercising leg will serve as control for the exercising leg.

Main study outcomes: Main study outcomes include upregulation of genes in skeletal muscle after exercise (with a focus on genes encoding myokines) and changes of blood plasma levels of selected proteins after exercise.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria:

- Age 40-60 years

- Male gender

- BMI < 30 kg/m2

Exclusion Criteria:

- Exercising regularly (> 2 times a week, > 3 hour in total per week)

- Unstable body weight (weight gain or loss > 3 kg in the past three months)

- Following, or have recently followed a (weight-loss) diet

- Donated or intended to donate blood 2 months before until two months after the study

- Medical condition that can interfere with the study outcome (i.e. cardiovascular disease, pulmonary disease)

- Systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg

- Use of medications known to interfere with gene expression in the muscles (i.e. statins, fenofibrate).

- Use of antithrombotic therapy (marcoumar, sintromitis).

- Diagnosed diabetes mellitus type 1 or 2.

- Drugs or alcohol abuse ( > 3 glasses of alcoholic beverages a day).

- (Chronic) injuries of the locomotor system that can interfere with the intervention

- Participated in another study within the last six months

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Single legged exercise
A single exercise bout that consists of one hour one-legged cycling on a adapted recumbent cycle ergometer at a submaximal rate. The non-exercising leg will serve as control for the exercising leg.

Locations

Country Name City State
Netherlands Division of Human Nutrition, Wageningen University Wageningen Gelderland

Sponsors (2)

Lead Sponsor Collaborator
Wageningen University Dutch Diabetes Research Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gene expression changes in skeletal muscle from baseline to after exercise Gene expression is measured using whole genome Affymatrix microarrays Muscle tissue will be collected at time points T = 0 (before exercise) and T = 1 (directly after exercise). Special focus is on the changes in genes coding for myokines. Up to 5 genes will be selected for follow-up analysis. T = 0 and T =1 No
Primary Changes in plasma levels of selected proteins Selected proteins will be analyzed by ELISA assays or western blot analysis, depending on ELISA availability at T = 0, T = 1 and T = 3 (2 hours post-exercise). The selection of the proteins is based on significance, the robustness of induction (>80% of subjects showing induction) and the magnitude of the induction ( mean fold change > 2) T = 0, T =1 and T = 3 No
Secondary PBMC gene expression changes before and after exercise Gene expression changes in the blood will be assessed using whole genome Affymetrix microarrays for the samples at T = 0, 1 and 3. T = 0, T = 1 and T =3 No
Secondary Routine plasma level changes before and after exercise At all three time point (T = 0, 1 and 3) plasma levels of glucose, insulin, fatty acids, triglycerides, cortisol, adrenalin and lactate will be determined. T = 0, 1 and 3 No
Secondary Heart rate changes, baseline compared with exercise Heart rate will be measured during the maximum work load test and the experimental exercise period. During the intervention No
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