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    Clinical Trial Results:
    Influence of muscle specific activation on regional glucose uptake in the human Achilles tendon

    Summary
    EudraCT number
    		 2004-004215-35
    Trial protocol
    		 FI  
    Global end of trial date
    31 Dec 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jan 2025
    First version publication date
    24 Jan 2025
    Other versions
    Summary report(s)
    		 Scientific report

    Trial information

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    Trial identification
    Sponsor protocol code
    TENPET
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Turku PET Centre/University of Turku
    Sponsor organisation address
    Kiinamyllynkatu 4-8, Turku, Finland, 20540
    Public contact
    Kari Kalliokoski, University of Turku, +358 405145437, kari.kalliokoski@tyks.fi
    Scientific contact
    Kari Kalliokoski, University of Turku, +358 405145437, kari.kalliokoski@tyks.fi
    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 Jan 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jan 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the present study is to investigate whether isolated activation (via electrical stimulation) of an individual triceps surae muscle (medial gastrocnemius) results in region specific activity at the level of the free tendon.
    Protection of trial subjects
    Hospital protection
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Mar 2005
    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
    Finland: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Advertisement at the University

    Pre-assignment
    Screening details
    		 Blood samples

    Pre-assignment period milestones
    Number of subjects started
    		 6
    Number of subjects completed
    		 6

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Test leg rest
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    18F-FDG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    185 MBq

    Number of subjects in period 1
    		Test leg rest
    Started
    6
    Completed
    6

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Test leg rest
    Reporting group description
    		 -

    Primary: Glucose uptake

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    End point title
    		 Glucose uptake [1]
    End point description
    End point type
    Primary
    End point timeframe
    One measurement
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: See the full paper
    End point values
    		 Test leg rest
    Number of subjects analysed
    6
    Units: index
        arithmetic mean (standard deviation)
    0.09 ( 0.02 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    No adverse events
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse event happened

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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