Chronic Beta2-adrenergic Stimulation and Cardiac and Skel... | NCT02551276

Studies
Chronic Beta2-adrenergic Stimulation and Cardiac and Skeletal Muscle Hypertrophy

NCT02551276

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Mar 15, 2016Estimated

Enrollment

42Actual

Phase

Not Applicable

Conditions

Muscle Hypertrophy in Healthy Young Men

Interventions

Salbutamol
Placebo
Resistance training

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2015Actual

First Submitted Date

Sep 12, 2015

First Submission Date that Met QC Criteria

Sep 14, 2015

First Posted Date

Sep 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2016

Last Update Posted Date

Mar 15, 2016Estimated

Name	Class
Bispebjerg Hospital	OTHER
University of Southern Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Beta2-adrenergic stimulation with salbutamol and resistance training for 10 weeks	Drug: Salbutamol Other: Resistance training
Control	Placebo Comparator	Placebo and resistance training for 10 weeks	Drug: Placebo Other: Resistance training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Salbutamol	Drug		Experimental
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Left Ventricular Hypertrophy (mass in grams)	Left Ventricular Mass (g) will be measured by echocardiography of the heart	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Smoker
Allergy towards study drug

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000420	Albuterol
D055070	Resistance Training

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided