cAMP Signaling and Muscle Adaptations

• Sponsor: University of Copenhagen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02557581
• Collaborator: (none)
• Enrollment: 72
• Locations: 2
• Arms: 3
• Duration (Months): 27
• Patients Per Site: 36
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Hypertrophy in Healthy Young Men	Other: No training; Other: Endurance training; Other: Resistance Training; Drug: Terbutaline; Drug: Clenbuterol; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Jun 30, 2017
• Anticipated Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Terbutaline Beta2-adrenergic stimulation with terbutaline	Other: No training; Other: Endurance training; Other: Resistance Training; Drug: Terbutaline
Placebo Comparator: Placebo Placebo	Other: No training; Other: Endurance training; Other: Resistance Training; Drug: Placebo
Experimental: Clenbuterol Beta2-adrenergic stimulation with clenbuterol	Other: No training; Drug: Clenbuterol

Outcome Measures

Primary Outcome Measures

1. Muscle hypertrophy (lean body mass in Kilograms) [2 days]

   Lean body mass (kg) will be measured at two different days by Dual X-ray absorbance (DXA)

Secondary Outcome Measures

1. Energy turnover (ml/min or mmol/kg dry weight muscle) [1 day]

   Pulmonary gas exchange and lactate and glycogen will be measured in muscle biopsies obtained before and after intense exercise

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nutrition, Exercise and Sports	Copenhagen		Denmark	2100
2	Bispebjerg University Hospital	Copenhagen		Denmark	2400

Sponsors and Collaborators

• University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Morten Nielsen, Post.Doc, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT02557581
• Other Study ID Numbers: TUD
• First Posted: Sep 23, 2015
• Last Update Posted: Oct 26, 2017
• Last Verified: Oct 1, 2017

• Additional relevant MeSH terms: Hypertrophy; Terbutaline; Clenbuterol

Study Results

No Results Posted as of Oct 26, 2017