NCT02557581

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

September 13, 2015

Last Update Submit

October 25, 2017

Conditions

Muscle Hypertrophy in Healthy Young Men

Outcome Measures

Primary Outcomes (1)

  • 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)

  • Energy turnover (ml/min or mmol/kg dry weight muscle)

    1 day

Study Arms (3)

Terbutaline

EXPERIMENTAL

Beta2-adrenergic stimulation with terbutaline

Other: No trainingOther: Endurance trainingOther: Resistance TrainingDrug: Terbutaline

Placebo

PLACEBO COMPARATOR

Placebo

Other: No trainingOther: Endurance trainingOther: Resistance TrainingDrug: Placebo

Clenbuterol

EXPERIMENTAL

Beta2-adrenergic stimulation with clenbuterol

Other: No trainingDrug: Clenbuterol

Interventions

No trainingOTHER
ClenbuterolPlaceboTerbutaline
Endurance trainingOTHER
PlaceboTerbutaline
Resistance TrainingOTHER
PlaceboTerbutaline
TerbutalineDRUG
Terbutaline
ClenbuterolDRUG
Clenbuterol
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy young men
  • 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

You may not qualify if:

  • Smoker
  • Allergy towards study drugs
  • Chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Nutrition, Exercise and Sports

Copenhagen, 2100, Denmark

RECRUITING

Bispebjerg University Hospital

Copenhagen, 2400, Denmark

RECRUITING

MeSH Terms

Interventions

Endurance TrainingResistance TrainingTerbutalineClenbuterol

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Central Study Contacts

Morten Hostrup, PhD

CONTACT

+4524474785mortenhostrup@gmail.com

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 13, 2015

First Posted

September 23, 2015

Study Start

July 1, 2015

Primary Completion

June 30, 2017

Study Completion

October 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

DK(2)