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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
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscle Hypertrophy in Healthy Young Men

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

    First Posted
    September 12, 2015
    Last Updated
    March 14, 2016
    Sponsor
    University of Copenhagen
    Collaborators
    Bispebjerg Hospital, University of Southern Denmark
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    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

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    Chronic Beta2-adrenergic Stimulation and Cardiac and Skeletal Muscle Hypertrophy

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