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cAMP Signaling and Muscle Adaptations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557581
Recruitment Status : Unknown
Verified October 2017 by Morten Nielsen, University of Copenhagen.
Recruitment status was:  Recruiting
First Posted : September 23, 2015
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Morten Nielsen, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE September 13, 2015
First Posted Date  ICMJE September 23, 2015
Last Update Posted Date October 26, 2017
Study Start Date  ICMJE July 2015
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
Muscle hypertrophy (lean body mass in Kilograms) [ Time Frame: 2 days ]
Lean body mass (kg) will be measured at two different days by Dual X-ray absorbance (DXA)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
Energy turnover (ml/min or mmol/kg dry weight muscle) [ Time Frame: 1 day ]
Pulmonary gas exchange and lactate and glycogen will be measured in muscle biopsies obtained before and after intense exercise
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
Muscle anaerobic energy turnover (mmol/kg dry weight muscle) [ Time Frame: 1 day ]
Lactate and glycogen will be measured in muscle biopsies obtained before and after intense exercise
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE cAMP Signaling and Muscle Adaptations
Official Title  ICMJE Not Provided
Brief Summary The role of cAMP signaling mediated by beta2-adrenergic stimulation with agonists has been well-studied in skeletal muscles of animals. Studies in humans are scant and the scope of the present study is thus to investigate the role of cAMP signaling by beta2-adrenergic stimulation for muscle adaptations in humans.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Muscle Hypertrophy in Healthy Young Men
Intervention  ICMJE
  • Other: No training
  • Other: Endurance training
  • Other: Resistance Training
  • Drug: Terbutaline
  • Drug: Clenbuterol
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Terbutaline
    Beta2-adrenergic stimulation with terbutaline
    Interventions:
    • Other: No training
    • Other: Endurance training
    • Other: Resistance Training
    • Drug: Terbutaline
  • Placebo Comparator: Placebo
    Placebo
    Interventions:
    • Other: No training
    • Other: Endurance training
    • Other: Resistance Training
    • Drug: Placebo
  • Experimental: Clenbuterol
    Beta2-adrenergic stimulation with clenbuterol
    Interventions:
    • Other: No training
    • Drug: Clenbuterol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 22, 2015)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy young men
  • 18-35 years of age
  • Informed consent
  • Active 2-5 hours of training pr. week
  • Maximal oxygen uptake (ml/min/kg) of 40-60
  • Lean body mass of 55-65 kg / Lean mass index 14-22 kg/m2

Exclusion Criteria:

  • Smoker
  • Allergy towards study drugs
  • Chronic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02557581
Other Study ID Numbers  ICMJE TUD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Morten Nielsen, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Copenhagen
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP