NCT02551276

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

September 12, 2015

Last Update Submit

March 14, 2016

Conditions

Muscle Hypertrophy in Healthy Young Men

Outcome Measures

Primary Outcomes (1)

  • 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)

    2 days

Secondary Outcomes (1)

  • Left Ventricular Hypertrophy (mass in grams)

    1 day

Study Arms (2)

Experimental

EXPERIMENTAL

Beta2-adrenergic stimulation with salbutamol and resistance training for 10 weeks

Drug: SalbutamolOther: Resistance training

Control

PLACEBO COMPARATOR

Placebo and resistance training for 10 weeks

Drug: PlaceboOther: Resistance training

Interventions

SalbutamolDRUG
Experimental
PlaceboDRUG
Control
Resistance trainingOTHER
ControlExperimental

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physical active
  • Non-smokers
  • Non-asthmatics
  • No chronic diseases
  • Informed consent

You may not qualify if:

  • Smoker
  • Allergy towards study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AlbuterolResistance Training

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post.Doc

Study Record Dates

First Submitted

September 12, 2015

First Posted

September 16, 2015

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2015

Last Updated

March 15, 2016

Record last verified: 2016-03