Response to Clenbuterol in Humans

August 8, 2024 updated by: Morten Hostrup, PhD, University of Copenhagen

Detectability of Clenbuterol and Physiological Response in Human Skeletal Muscle

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..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • August Krogh Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of clenbuterol

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug
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
Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug
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
Before (baseline) and 2.5 hours after administration of study drug
Muscle signalling
Time Frame: Before (baseline) and 2.5 hours after administration of study drug
Protein kinase A phosphorylation in vastus lateralis biopsies
Before (baseline) and 2.5 hours after administration of study drug
Plasma K+
Time Frame: Before (baseline) as well as 2.5 hours after administration of study drug
Venous plasma K+ concentration
Before (baseline) as well as 2.5 hours after administration of study drug
Muscle mTOR signalling
Time Frame: Before (baseline) as well as 2.5 hours after administration of study drug
mTOR phosphorylation in vastus lateralis biopsies
Before (baseline) as well as 2.5 hours after administration of study drug
Metabolic rate
Time Frame: Before (baseline) as well as 2.5 hours after administration of study drug
Respriatory exchange ratio of oxygen and CO2
Before (baseline) as well as 2.5 hours after administration of study drug
Maximal voluntary strength
Time Frame: Before (baseline) and after two-week treatment of study drug
Maximal voluntary isometric muscle strength of the quadriceps
Before (baseline) and after two-week treatment of study drug
Body composition
Time Frame: Before (baseline) and after two-week treatment of study drug
Lean and fat mass during a DXA-scan
Before (baseline) and after two-week treatment of study drug
Aerobic capacity
Time Frame: Before (baseline) and after two-week treatment of study drug
Maximal oxygen uptake during maximal exercise
Before (baseline) and after two-week treatment of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2019

Primary Completion (Actual)

December 21, 2022

Study Completion (Actual)

December 21, 2022

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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