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    Clinical Trial Results:
    The influence of metformin and a hypocaloric diet on thyroid radioactive iodide uptake in healthy volunteers: a pilot study

    Summary
    EudraCT number
    		 2016-001455-42
    Trial protocol
    		 NL  
    Global end of trial date
    02 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Feb 2020
    First version publication date
    11 Feb 2020
    Other versions
    Summary report(s)
    		 Article Scientific Reports on Pilot study

    Trial information

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    Trial identification
    Sponsor protocol code
    NL56309.091.16
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Nederlands Trial Register: NTR5853
    Sponsors
    Sponsor organisation name
    Radboud Universitair Medisch Centrum
    Sponsor organisation address
    Geert Grooteplein Zuid 8, Nijmegen , Netherlands,
    Public contact
    Internal Medicine-Endocrine Disease, Radboud Universitair Medisch Centrum, 0031 0243614599,
    Scientific contact
    Internal Medicine-Endocrine Disease, Radboud Universitair Medisch Centrum, 0031 0243614599,
    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
    31 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the physiological effects of metformin and hypocaloric dieting on thyroid iodide uptake and thyroid function in healthy volunteers.
    Protection of trial subjects
    A complete health screening before enrollment was performed. Participants were sent home with contact information and clear instructions when to contact the emergency number During the intervention period, participants were contacted one week after starting intervention to check whether there are any complaints or complications or questions Because of the low risk of either intervention, no additional specific measurements are taken.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2016
    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: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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)
    19
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were invited to participate through advertisements on the Radboud University Medical Centre website and local university websites and placement of advertisements in the medical faculty, other locations on campus and in the city centre between October and April 2017

    Pre-assignment
    Screening details
    		 Complete medical history and physical examination, including height, weight, BMI, and hip- and waist circumferences, and skinfold measurements.. A laboratory test was performed for screen for kidney disorder and thyroid disorders.

    Pre-assignment period milestones
    Number of subjects started
    		 29 [1]
    Number of subjects completed
    		 19

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 9
    Reason: Number of subjects
    		 Protocol deviation: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: More possible participants were screened; 9 of them dropped out before start of the trial; therefore, according to the protocol, we recruited more participants and screened them to reach our desired number for each subgroup.
    Period 1
    Period 1 title
    baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Baseline - controle
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 baseline diet
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 baseline metformin
    Arm description
    		 -
    Arm type
    		 baseline

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    during baseline: no metformin intake

    Number of subjects in period 1
    		Baseline - controle baseline diet baseline metformin
    Started
    4
    7
    8
    baseline measurement
    4
    7
    8
    Completed
    4
    7
    8
    Period 2
    Period 2 title
    Intervention period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 Iodide depleted diet
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Hypocaloric diet
    Arm description
    		 Hypocaloric diet; 40% caloric restriction (maximum of 1500 kcal/day) with high fat/low carbohydrate content (50% fat, 30% carbohydrate, 20% protein) for two weeks.
    Arm type
    		 intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Metformin
    Arm description
    		 2-week course of metformin according to a dosing schedule
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosing of Metformin: • Day 1: 1 x 500 mg (dinner) • Day 2: 1 x 500 mg (breakfast) & 1 x 500 mg (dinner) • Day 3: 1 x 500 mg (breakfast) & 1 x 500 mg (dinner) • Day 4: 1 x 500 mg (breakfast) & 2 x 500 mg (dinner) • Day 5: 2 x 500 mg (breakfast) & 2 x 500 mg (dinner) • Day 6 –End of study: 2 x 500 mg (breakfast) & 2 x 500 mg (dinner)

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosing of Metformin: • Day 1: 1 x 500 mg (dinner) • Day 2: 1 x 500 mg (breakfast) & 1 x 500 mg (dinner) • Day 3: 1 x 500 mg (breakfast) & 1 x 500 mg (dinner) • Day 4: 1 x 500 mg (breakfast) & 2 x 500 mg (dinner) • Day 5: 2 x 500 mg (breakfast) & 2 x 500 mg (dinner) • Day 6 –End of study: 2 x 500 mg (breakfast) & 2 x 500 mg (dinner)

    Number of subjects in period 2
    		Control Hypocaloric diet Metformin
    Started
    4
    7
    8
    Completed
    4
    7
    8

    Baseline characteristics

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

    Reporting group values
    		 baseline Total
    Number of subjects
    		 19 19
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 19 19
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        not recorded
    		 0 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 24.7 ( 5.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 19 19

    End points

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    End points reporting groups
    Reporting group title
    Baseline - controle
    Reporting group description
    		 -

    Reporting group title
    baseline diet
    Reporting group description
    		 -

    Reporting group title
    baseline metformin
    Reporting group description
    		 -
    Reporting group title
    Control
    Reporting group description
    		 Iodide depleted diet

    Reporting group title
    Hypocaloric diet
    Reporting group description
    		 Hypocaloric diet; 40% caloric restriction (maximum of 1500 kcal/day) with high fat/low carbohydrate content (50% fat, 30% carbohydrate, 20% protein) for two weeks.

    Reporting group title
    Metformin
    Reporting group description
    		 2-week course of metformin according to a dosing schedule

    Primary: Thyroid iodide uptake

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    End point title
    		 Thyroid iodide uptake [1]
    End point description
    Primary endpoint of this study is to assess the effect of metformin and hypocaloric diet on thyroid iodide uptake. 123I thyroid uptake is measured by RAIU testing using a gamma probe. Uptake is presented as percentage of total administrated 123I after 4, 24 and 48 hours after ingestion I-123.
    End point type
    Primary
    End point timeframe
    thyroid uptake is measured by RAIU testing using a gamma probe. Uptake is presented as percentage of total administrated 123I after 4, 24 and 48 hours after ingestion I-123.
    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 summary document for full discription on statiscal analysis and final results
    End point values
    		 Control Hypocaloric diet Metformin
    Number of subjects analysed
    4
    7
    8
    Units: gamma counts
    32
    35
    29
    Attachments
    		 fig 2
    No statistical analyses for this end point

    Secondary: TSH

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    End point title
    		 TSH
    End point description
    End point type
    Secondary
    End point timeframe
    baseline and post-intervention
    End point values
    		 Control Hypocaloric diet Metformin
    Number of subjects analysed
    4
    7
    8
    Units: mE/L
        log mean (standard deviation)
    0.23 ( 0.18 )
    0.23 ( 0.23 )
    0.34 ( 0.18 )
    Attachments
    		 figure 1
    No statistical analyses for this end point

    Secondary: fT4

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    End point title
    		 fT4
    End point description
    End point type
    Secondary
    End point timeframe
    baseline and post-intervention
    End point values
    		 Control Hypocaloric diet Metformin
    Number of subjects analysed
    4
    7
    8
    Units: pmol/L
        geometric mean (standard deviation)
    16.65 ( 4.27 )
    16.8 ( 1.35 )
    17.36 ( 1.61 )
    Attachments
    		 figure 1
    No statistical analyses for this end point

    Secondary: T3

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    End point title
    		 T3
    End point description
    End point type
    Secondary
    End point timeframe
    baseline and post-intervention
    End point values
    		 Control Hypocaloric diet Metformin
    Number of subjects analysed
    4
    7
    8
    Units: nmol/l
        geometric mean (standard deviation)
    2.07 ( 0.5 )
    2.01 ( 0.38 )
    1.95 ( 0.19 )
    Attachments
    		 figure 1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening - baseline measurement - check up 1 week after intervention - post - intervention measurements. Participants received information and contact information for when adverse events occured.
    Adverse event reporting additional description
    All AEs will be followed until they have abated, or until a stable situation has been reached.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Control
    Reporting group description
    		 -

    Reporting group title
    Hypocaloric dieting
    Reporting group description
    		 -

    Reporting group title
    Metformin
    Reporting group description
    		 non serious side effects: minor gastro-intenstinal compaints after starting metfromin treatment.

    Serious adverse events
    		 Control Hypocaloric dieting Metformin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Control Hypocaloric dieting Metformin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    5 / 8 (62.50%)
    Gastrointestinal disorders
    diarrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    5 / 8 (62.50%)
         occurrences all number
    0
    0
    5

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30932012
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