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    Clinical Trial Results:
    Targeting the beta-2 adrenergic pathway to improve skeletal muscle glucose uptake in healthy humans

    Summary
    EudraCT number
    		 2018-004245-16
    Trial protocol
    		 NL  
    Global end of trial date
    23 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Aug 2022
    First version publication date
    18 Aug 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NL67646.068.18
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Maastricht University
    Sponsor organisation address
    Universiteitssingel 50, Maastricht , Netherlands,
    Public contact
    Clinicaltrials.gov, Maastricht University, 0031 0433884254, Sten.vanbeek@maastrichtuniversity.nl
    Scientific contact
    Clinicaltrials.gov, Maastricht University, 0031 0433884254, Sten.vanbeek@maastrichtuniversity.nl
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if prolonged treatment with the selective beta-2-adrenergic agonist clenbuterol improves skeletal muscle glucose disposal via the mTORC2 pathway in lean, healthy male individuals with normal physical activity.
    Protection of trial subjects
    Performed measurements will be without risks, but hematomas or bruises could develop upon blood sampling or muscle biopsies taken. This risk will be minimized due to state-of-the-art techniques and sterility measures taken. Clenbuterol or placebo supplementation will be given for 14 days, in which subjects ingest 1 capsule (20 microg) twice daily (40 microg/day). Clenbuterol could induce adverse effects, e.g. headache, increased heart rate/blood pressure, tremors, dizziness. To minimize the risks of adverse events, we deliberately choose to perform the study in a young, healthy population, using a standard dose clenbuterol (40 microg/day) as well as a short treatment duration. To limit the number of subjects that need to be included we decided for a cross-over design in which every participant serves as his own control.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Apr 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects were screened for age and BMI

    Period 1
    Period 1 title
    Placebo
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 Placebo
    Arm description
    		 In a randomised, placebo-controlled, double-blinded, cross-over study, subjects received either clenbuterol hydrochloride or a placebo for 2 weeks. Afterwards, a 4-week wash-out was performed, after which subjects would receive another 2 weeks with the other compound that was not received in the first period
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for comparison

    Number of subjects in period 1
    		Placebo
    Started
    12
    Completed
    11
    Not completed
    1
         COVID-19 pandemic
    1
    Period 2
    Period 2 title
    Clenbuterol hydrochloride
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 Clenbuterol hydrochloride
    Arm description
    		 In a randomised, placebo-controlled, double-blinded, cross-over study, subjects received either clenbuterol hydrochloride or a placebo for 2 weeks. Afterwards, a 4-week wash-out was performed, after which subjects would receive another 2 weeks with the other compound that was not received in the first period
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clenbuterol hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 2x 20 microg of clenbuterol daily (= 40 microg/day)

    Number of subjects in period 2
    		Clenbuterol hydrochloride
    Started
    11
    Completed
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 24.9 ( 3.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 12 12
    BMI
    Units: kg/m2
        geometric mean (standard deviation)
    		 ( ) -
    Systolic blood pressure
    Units: mmHg
        geometric mean (standard deviation)
    		 ( ) -
    Diastolic blood pressure
    Units: mmHg
        geometric mean (standard deviation)
    		 ( ) -
    Heart rate
    Units: Beats/min
        geometric mean (standard deviation)
    		 ( ) -
    ALAT
    Units: U/L
        geometric mean (standard deviation)
    		 ( ) -
    ASAT
    Units: U/L
        geometric mean (standard deviation)
    		 ( ) -
    gamma-GT
    Units: U/L
        geometric mean (standard deviation)
    		 ( ) -
    Creatinine
    Units: micromole(s)/litre
        geometric mean (standard deviation)
    		 ( ) -
    Haemoglobin
    Units: mmol/L
        geometric mean (standard deviation)
    		 ( ) -
    Potassium
    Units: mmol/L
        geometric mean (standard deviation)
    		 ( ) -
    TSH
    Units: mU/L
        geometric mean (standard deviation)
    		 ( ) -
    Subject analysis sets

    Subject analysis set title
    Baseline characteristics
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Baseline characteristics

    Subject analysis sets values
    		 Baseline characteristics
    Number of subjects
    11
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        geometric mean (standard deviation)
    24.9 ( 3.7 )
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    11
    BMI
    Units: kg/m2
        geometric mean (standard deviation)
    23.1 ( 1.9 )
    Systolic blood pressure
    Units: mmHg
        geometric mean (standard deviation)
    120 ( 9.9 )
    Diastolic blood pressure
    Units: mmHg
        geometric mean (standard deviation)
    72 ( 6.7 )
    Heart rate
    Units: Beats/min
        geometric mean (standard deviation)
    58 ( 6.4 )
    ALAT
    Units: U/L
        geometric mean (standard deviation)
    25 ( 11 )
    ASAT
    Units: U/L
        geometric mean (standard deviation)
    23 ( 7 )
    gamma-GT
    Units: U/L
        geometric mean (standard deviation)
    19 ( 6 )
    Creatinine
    Units: micromole(s)/litre
        geometric mean (standard deviation)
    82 ( 7 )
    Haemoglobin
    Units: mmol/L
        geometric mean (standard deviation)
    9.6 ( 0.5 )
    Potassium
    Units: mmol/L
        geometric mean (standard deviation)
    4.25 ( 0.22 )
    TSH
    Units: mU/L
        geometric mean (standard deviation)
    2.2 ( 1.0 )

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 In a randomised, placebo-controlled, double-blinded, cross-over study, subjects received either clenbuterol hydrochloride or a placebo for 2 weeks. Afterwards, a 4-week wash-out was performed, after which subjects would receive another 2 weeks with the other compound that was not received in the first period
    Reporting group title
    Clenbuterol hydrochloride
    Reporting group description
    		 In a randomised, placebo-controlled, double-blinded, cross-over study, subjects received either clenbuterol hydrochloride or a placebo for 2 weeks. Afterwards, a 4-week wash-out was performed, after which subjects would receive another 2 weeks with the other compound that was not received in the first period

    Subject analysis set title
    Baseline characteristics
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Baseline characteristics

    Primary: insulin-stimulated glucose disposal

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    End point title
    		 insulin-stimulated glucose disposal
    End point description
    End point type
    Primary
    End point timeframe
    2 weeks
    End point values
    		 Clenbuterol hydrochloride Placebo
    Number of subjects analysed
    11
    11
    Units: microM/kg/min
        geometric mean (standard error)
    41.2 ( 2.7 )
    46.6 ( 3.5 )
    Statistical analysis title
    		 Analysis primary end point
    Statistical analysis description
    Data was compared with a Paired T-test due to cross-over design. Thus, all subjects were their own control.
    Comparison groups
    Placebo v Clenbuterol hydrochloride
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.02
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: GLUT4 translocation

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    End point title
    		 GLUT4 translocation
    End point description
    End point type
    Secondary
    End point timeframe
    2-weeks
    End point values
    		 Clenbuterol hydrochloride Placebo
    Number of subjects analysed
    11
    11
    Units: Arbitrary units
        geometric mean (standard error)
    56.1 ( 4.0 )
    55.4 ( 3.6 )
    Statistical analysis title
    		 statistical analyses secondary outcome
    Statistical analysis description
    Data was compared with a Paired T-test due to cross-over design. Thus, all subjects were their own control.
    Comparison groups
    Clenbuterol hydrochloride v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.865 [1]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - paired T-test

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    13-08-2019 till 23-04-2022
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Clenbuterol hydrochloride
    Reporting group description
    		 -

    Serious adverse events
    		 Clenbuterol hydrochloride
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Clenbuterol hydrochloride
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 11 (45.45%)
    Nervous system disorders
    Tremor in hands
         subjects affected / exposed
    5 / 11 (45.45%)
         occurrences all number
    5
    Feeling anxious / restless
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Muscle ache, tense muscles or cramps
         subjects affected / exposed
    4 / 11 (36.36%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Aug 2019
    Added flow-mediated dilation measurement to protocol

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    16 Mar 2020
    Due to the COVID-19 pandemic in the Netherlands, the study had been temporarily halted
    01 Jul 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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