- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02551276
Chronic Beta2-adrenergic Stimulation and Cardiac and Skeletal Muscle Hypertrophy
March 14, 2016 updated by: Morten Nielsen, University of Copenhagen
Role of 11 Weeks of Beta2-adrenergic Signaling and Resistance Training for Cardiac and Skeletal Muscle Hypertrophy in Men
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Physical active
- Non-smokers
- Non-asthmatics
- No chronic diseases
- Informed consent
Exclusion Criteria:
- Smoker
- Allergy towards study drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Beta2-adrenergic stimulation with salbutamol and resistance training for 10 weeks
|
|
Placebo Comparator: Control
Placebo and resistance training for 10 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skeletal 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)
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Left Ventricular Hypertrophy (mass in grams)
Time Frame: 1 day
|
Left Ventricular Mass (g) will be measured by echocardiography of the heart
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
September 12, 2015
First Submitted That Met QC Criteria
September 14, 2015
First Posted (Estimate)
September 16, 2015
Study Record Updates
Last Update Posted (Estimate)
March 15, 2016
Last Update Submitted That Met QC Criteria
March 14, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Hypertrophy
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
Other Study ID Numbers
- SAL-STYRKE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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