cAMP Signaling and Muscle Adaptations
Primary Purpose
Muscle Hypertrophy in Healthy Young Men
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
No training
Endurance training
Resistance Training
Terbutaline
Clenbuterol
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Muscle Hypertrophy in Healthy Young Men
Eligibility Criteria
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
Sites / Locations
- Department of Nutrition, Exercise and SportsRecruiting
- Bispebjerg University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Terbutaline
Placebo
Clenbuterol
Arm Description
Beta2-adrenergic stimulation with terbutaline
Placebo
Beta2-adrenergic stimulation with clenbuterol
Outcomes
Primary Outcome Measures
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
Energy turnover (ml/min or mmol/kg dry weight muscle)
Pulmonary gas exchange and lactate and glycogen will be measured in muscle biopsies obtained before and after intense exercise
Full Information
NCT ID
NCT02557581
First Posted
September 13, 2015
Last Updated
October 25, 2017
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT02557581
Brief Title
cAMP Signaling and Muscle Adaptations
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Terbutaline
Arm Type
Experimental
Arm Description
Beta2-adrenergic stimulation with terbutaline
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Clenbuterol
Arm Type
Experimental
Arm Description
Beta2-adrenergic stimulation with clenbuterol
Intervention Type
Other
Intervention Name(s)
No training
Intervention Type
Other
Intervention Name(s)
Endurance training
Intervention Type
Other
Intervention Name(s)
Resistance Training
Intervention Type
Drug
Intervention Name(s)
Terbutaline
Intervention Type
Drug
Intervention Name(s)
Clenbuterol
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Energy turnover (ml/min or mmol/kg dry weight muscle)
Description
Pulmonary gas exchange and lactate and glycogen will be measured in muscle biopsies obtained before and after intense exercise
Time Frame
1 day
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morten Hostrup, PhD
Phone
+4524474785
Email
mortenhostrup@gmail.com
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Hostrup, PhD
Phone
+4524474785
Email
mortenhostrup@gmail.com
Facility Name
Bispebjerg University Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Hostrup, PhD
Phone
+4524474785
Email
mortenhostrup@gmail.com
12. IPD Sharing Statement
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cAMP Signaling and Muscle Adaptations
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