Chronic Beta2-adrenergic Stimulation and Cardiac and Skeletal Muscle Hypertrophy
Primary Purpose
Muscle Hypertrophy in Healthy Young Men
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Salbutamol
Placebo
Resistance training
Sponsored by
About this trial
This is an interventional basic science trial for Muscle Hypertrophy in Healthy Young Men
Eligibility Criteria
Inclusion Criteria:
- Physical active
- Non-smokers
- Non-asthmatics
- No chronic diseases
- Informed consent
Exclusion Criteria:
- Smoker
- Allergy towards study drug
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Control
Arm Description
Beta2-adrenergic stimulation with salbutamol and resistance training for 10 weeks
Placebo and resistance training for 10 weeks
Outcomes
Primary Outcome Measures
Skeletal Muscle Hypertrophy (lean body mass in Kilograms)
Lean body mass (kg) will be measured at two different days by Dual X-ray absorbance (DXA)
Secondary Outcome Measures
Left Ventricular Hypertrophy (mass in grams)
Left Ventricular Mass (g) will be measured by echocardiography of the heart
Full Information
NCT ID
NCT02551276
First Posted
September 12, 2015
Last Updated
March 14, 2016
Sponsor
University of Copenhagen
Collaborators
Bispebjerg Hospital, University of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02551276
Brief Title
Chronic Beta2-adrenergic Stimulation and Cardiac and Skeletal Muscle Hypertrophy
Official Title
Role of 11 Weeks of Beta2-adrenergic Signaling and Resistance Training for Cardiac and Skeletal Muscle Hypertrophy in Men
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Bispebjerg Hospital, University of Southern Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Studies in animals have shown that beta2-adrenoceptor activation with selective agonists regulates protein metabolism and muscle growth in skeletal and cardiac muscle tissue. These effects may be mediated by cAMP/PKA dependent activation of several downstream sites that modulate protein synthesis and breakdown. While the role of beta2-adrenoceptor signaling is well-described in animals, it is inadequately explored in humans. The purpose of the study is thus to investigate the effect of chronic beta2-adrenergic stimulation (cAMP/PKA-signaling) on muscle hypertrophy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Hypertrophy in Healthy Young Men
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Beta2-adrenergic stimulation with salbutamol and resistance training for 10 weeks
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo and resistance training for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Salbutamol
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Other
Intervention Name(s)
Resistance training
Primary Outcome Measure Information:
Title
Skeletal Muscle Hypertrophy (lean body mass in Kilograms)
Description
Lean body mass (kg) will be measured at two different days by Dual X-ray absorbance (DXA)
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Left Ventricular Hypertrophy (mass in grams)
Description
Left Ventricular Mass (g) will be measured by echocardiography of the heart
Time Frame
1 day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Physical active
Non-smokers
Non-asthmatics
No chronic diseases
Informed consent
Exclusion Criteria:
Smoker
Allergy towards study drug
12. IPD Sharing Statement
Learn more about this trial
Chronic Beta2-adrenergic Stimulation and Cardiac and Skeletal Muscle Hypertrophy
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