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    Clinical Trial Results:
    The effect of lactate administration on cerebral blood flow during hypoglycemia

    Summary
    EudraCT number
    		 2018-000684-82
    Trial protocol
    		 NL  
    Global end of trial date
    14 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2022
    First version publication date
    25 Jun 2022
    Other versions
    Summary report(s)
    		 Paper Effect of lactate on CBF

    Trial information

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    Trial identification
    Sponsor protocol code
    2017-3968
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03730909
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands,
    Public contact
    clinical research centre nijmegen, Radboud umc, crcn@radboudumc.nl
    Scientific contact
    clinical research centre nijmegen, Radboud umc, crcn@radboudumc.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 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    14 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of intravenous lactate administration, compared to placebo, on thalamic (regional) CBF during euglycemia and hypoglycemia in patients with T1DM and normal awareness of hypoglycemia.
    Protection of trial subjects
    We did not use specific measures to protect trial subjects
    Background therapy
    		 -
    Evidence for comparator
    		 We used saline 0.9% infusion as a comparator. This is often used as a placebo to compare results to the test product. We can use the same amount of saline as the test product and it looks the same (from the outside) so it is suitable to use in a blinded study.
    Actual start date of recruitment
    11 Jun 2018
    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: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    9
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment of patients between 11th of June 2018 and 14th of May in 2019.

    Pre-assignment
    Screening details
    		 Inclusion criteria: type 1 diabetes, age <50 years, BMI <30 kg/m2, and HbA1c levels not exceeding 9.0% (75 mmol/mol). Exclusion criteria: medication other than insulin, presence of any other medical condition, micro- and macrovascular complications of diabetes en contraindications for MRI. Three participants withdrawn, two were replaced.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    We used bags to cover the sodium lactate and sodium chloride infusion fluids

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sodium lactate
    Arm description
    		 Sodium lactate infusion day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sodium lactate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Sodium lactate 600 mmol/L Sodium lactate infusion was started in a dose of 40 µmol/kg/min for 15 min, and then continued in a dose of 25 µmol/kg/min for the remainder of the experiment

    Arm title
    		 Sodium chloride
    Arm description
    		 Sodium chloride 0.9% infusion day
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Sodium chloride 0.9% 500 mL, administered in an equivalent volume as compared to lactate infusion

    Number of subjects in period 1
    		Sodium lactate Sodium chloride
    Started
    5
    4
    Completed
    5
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Ten subjects were included, three withdrew consent, two of them were replaced and therefore the results of nine subjects were analysed. Mean age was 23.0±3.6 years, 4 male and 5 female subjects. Mean weight was 75.1±13.7 kg, and BMI 23.6±2.8 kg/m2. Median duration of diabetes was 7.0 (3.0–10.5) years. Mean HbA1c was 7.1±1.0 % (54.2±11.1 mmol/mol).

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 9 9
    Age categorical
    Mean age 23.0±3.6 years
    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)
    		 9 9
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    mean age 23.0±3.6 years
    Units: years
        geometric mean (standard deviation)
    		 23 ( 3.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    Sodium lactate
    Reporting group description
    		 Sodium lactate infusion day

    Reporting group title
    Sodium chloride
    Reporting group description
    		 Sodium chloride 0.9% infusion day

    Primary: Hypoglycemic symptom score

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    End point title
    		 Hypoglycemic symptom score
    End point description
    End point type
    Primary
    End point timeframe
    during hypoglycemia (45 minutes)
    End point values
    		 Sodium lactate Sodium chloride
    Number of subjects analysed
    5
    4
    Units: points
        number (not applicable)
    26.7
    26.1
    Statistical analysis title
    		 T-test hypoglycemic symptom score
    Comparison groups
    Sodium lactate v Sodium chloride
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Notes
    [1] - Paired t-test for hypoglycemic symptoms during the two hypoglycemic glucose clamps

    Secondary: Glucose infusion rates

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    End point title
    		 Glucose infusion rates
    End point description
    End point type
    Secondary
    End point timeframe
    during hypoglycemic glucose clamp
    End point values
    		 Sodium lactate Sodium chloride
    Number of subjects analysed
    5
    4
    Units: mg/kg/min
        number (not applicable)
    3.7
    3.5
    Statistical analysis title
    		 T-test glucose infusion rate
    Comparison groups
    Sodium lactate v Sodium chloride
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 week after hypoglycemic clamp
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 not used
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 9 (11.11%)
    General disorders and administration site conditions
    Vasovagal syncope
    Additional description: One participant experienced vasovagal syncope after cannulation of intravenous catheters. Duration several seconds and it resolved without any further interventions
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1

    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.
    Limitations: sample size, difference in electrolyte concentration between sodium chloride and sodium lactate
    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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