Back to resultsMyocellular Signalling in Skeletal Muscle
Primary Purpose
Exercise, Insulin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Insulin
Exercise
Sponsored by
About this trial
This is an interventional basic science trial for Exercise
Eligibility Criteria
Inclusion Criteria:
- healthy
- informed consent
- habitual training (2-5 h/week)
- VO2max of 40-60 ml/min/kg
- lean mass 55-65 kg
Exclusion Criteria:
- smoker
- allergy towards insulin
- chronic disease
Sites / Locations
- August Krogh Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Insulin-stimulation
Exercise
Arm Description
2 h insulin-clamp
10 min of maximal exercise
Outcomes
Primary Outcome Measures
Change in muscle phospho-proteome signature
proteomic analysis of mixed muscle homogenate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03203317
Brief Title
Myocellular Signalling in Skeletal Muscle
Official Title
Insulin-dependent and Exercise-induced Myocellular Signalling in Skeletal Muscle
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
July 26, 2017 (Actual)
Study Completion Date
July 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study will investigate myocellular signalling in skeletal muscle after insulin-stimulation and exercise in healthy young men
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Insulin Sensitivity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin-stimulation
Arm Type
Experimental
Arm Description
2 h insulin-clamp
Arm Title
Exercise
Arm Type
Experimental
Arm Description
10 min of maximal exercise
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
2 h insulin clamp
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Cycling exercise
Primary Outcome Measure Information:
Title
Change in muscle phospho-proteome signature
Description
proteomic analysis of mixed muscle homogenate
Time Frame
Before and after 10 minutes of exercise, as well as before and after a 2 hour insulin stimulation
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy
informed consent
habitual training (2-5 h/week)
VO2max of 40-60 ml/min/kg
lean mass 55-65 kg
Exclusion Criteria:
smoker
allergy towards insulin
chronic disease
Facility Information:
Facility Name
August Krogh Building
City
Copenahgen
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Myocellular Signalling in Skeletal Muscle
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