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Response to Clenbuterol in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03860870
Recruitment Status : Unknown
Verified April 2021 by Morten Hostrup, PhD, University of Copenhagen.
Recruitment status was:  Recruiting
First Posted : March 4, 2019
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Morten Hostrup, PhD, University of Copenhagen

Study Description
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Brief Summary:
Due to the long half-life (~36 hr) of clenbuterol, detection methods such as dried blood spots (DBS) are a potentially suitable method to easily and non-invasively detect doping misuse of this compound for several days after ingestion. If, and how long, the compound can be detected by DBS has not yet been investigated but is of interest due to its potential in doping-control. The aim is to evaluate whether abuse of clenbuterol can be detected at relevant concentration levels in samples obtained using DBS and to assess the physiological response to clenbuterol in skeletal muscle..

Condition or disease Intervention/treatment Phase
Healthy Drug: Clenbuterol Oral Product Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Two phases:

First phase sequential Second phase crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: First phase - open label Second phase - double-blinded
Primary Purpose: Basic Science
Official Title: Detectability of Clenbuterol and Physiological Response in Human Skeletal Muscle
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : March 15, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Clenbuterol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Clenbuterol
Subjects ingest 80 micrograms of clenbuterol tablets
 Drug: Clenbuterol Oral Product
Subjects ingest 4x20 microgram clenbuterol tablets
Placebo Comparator: Placebo
Subjects ingest placebo tablets
 Drug: Placebo
Subjects ingest placebo tablets


Outcome Measures
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Primary Outcome Measures :
  1. Blood clenbuterol concentration [ Time Frame: Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of clenbuterol ]
    Concentration of clenbuterol in dried blood spots


Secondary Outcome Measures :
  1. Blood clenbuterol concentration [ Time Frame: Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug ]
    Concentration of clenbuterol in venous blood

  2. Urine clenbuterol concentration [ Time Frame: Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug ]
    Concentration of clenbuterol in urine

  3. Muscle strength [ Time Frame: Before (baseline) and 2.5 hours after administration of study drug ]
    Maximal voluntary isometric contraction in N/m2 of the quadriceps

  4. Muscle signalling [ Time Frame: Before (baseline) and 2.5 hours after administration of study drug ]
    Protein kinase A phosphorylation in vastus lateralis biopsies

  5. Plasma K+ [ Time Frame: Before (baseline) as well as 2.5 hours after administration of study drug ]
    Venous plasma K+ concentration

  6. Muscle mTOR signalling [ Time Frame: Before (baseline) as well as 2.5 hours after administration of study drug ]
    mTOR phosphorylation in vastus lateralis biopsies

  7. Metabolic rate [ Time Frame: Before (baseline) as well as 2.5 hours after administration of study drug ]
    Respriatory exchange ratio of oxygen and CO2

  8. Maximal voluntary strength [ Time Frame: Before (baseline) and after two-week treatment of study drug ]
    Maximal voluntary isometric muscle strength of the quadriceps

  9. Body composition [ Time Frame: Before (baseline) and after two-week treatment of study drug ]
    Lean and fat mass during a DXA-scan

  10. Aerobic capacity [ Time Frame: Before (baseline) and after two-week treatment of study drug ]
    Maximal oxygen uptake during maximal exercise


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Male
  • 18-40 years of age
  • No known contraindications for anabolic drugs (e.g. cancer)

Exclusion Criteria:

  • Abnormal ECG
  • Steroid abuse
  • Ongoing use of prescription medication
  • heavy resistance training more than 2 times weekly
  • Disease deemed by the MD to infer a risk to participate in the trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860870


Locations
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Denmark
August Krogh Building Recruiting
Copenhagen, Denmark
Contact: Morten Hostrup, PhD    +4524474785    mhostrup@nexs.ku.dk   
Sponsors and Collaborators
University of Copenhagen
More Information
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Responsible Party: Morten Hostrup, PhD, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03860870    
Other Study ID Numbers: CLEN
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Morten Hostrup, PhD, University of Copenhagen:
dried blood spots
skeletal muscle biopsies
muscle strength
muscle signaling
Additional relevant MeSH terms:
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Clenbuterol
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics