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    Clinical Trial Results:
    Diet, physical exercise, and metabolic control intervention to reduce the incidence of major neurocognitive disorders among individuals with type 2 diabetes combined with mild neurocognitive impairment – a pilot study

    Summary
    EudraCT number
    		 2019-003772-39
    Trial protocol
    		 SE  
    Global end of trial date
    28 Feb 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2022
    First version publication date
    28 Oct 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DEMAND-pilot
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03877783
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Umeå University
    Sponsor organisation address
    Department of Public Health and Clinical Medicine, Family Medicine, Umeå University, Umeå, Sweden, 90187
    Public contact
    Olov Rolandsson, Umeå University, +46 705902052, olov.rolandsson@umu.se
    Scientific contact
    Olov Rolandsson, Umeå University, +46 705902052, olov.rolandsson@umu.se
    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
    07 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether the chosen study design is feasible in terms of recruitment, retainment, adherence, and acceptance.
    Protection of trial subjects
    The study participants were followed regularly, both by study visits and by phone calls. All study participants were interviewed to minimize stress and discomfort. Adverse Events were registered from study start (randomisation) until the last study visit. All reported SAEs that had not been resolved by the end of the study was followed up until the event had subsided (or disappeared), the condition was stabilized, the event was otherwise explained or the study subject was lost to follow-up.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Oct 2020
    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
    Sweden: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    0
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects were recruited via advertisements posted in national and local newspapers and in social media. Persons identifed with diagnosis of diabetes type 2 based on ICD codes also received a letter of invitation to participate in the study.

    Pre-assignment
    Screening details
    		 Persons interested in participating in the study were pre-screened by phone. If determined as suitable for the study , a screening visit at site was performed where xxxxx

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 Intervention consisting of a Mediterranean diet, an individualized physical training program and optimal pharmacological treatment for T2D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PR1
    Investigational medicinal product code
    A10BA02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 gram/day

    Investigational medicinal product name
    PR2
    Investigational medicinal product code
    A10BK01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 milligram/day

    Investigational medicinal product name
    PR3
    Investigational medicinal product code
    A10BK02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 milligram/day

    Investigational medicinal product name
    PR4
    Investigational medicinal product code
    A10BK03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 milligram/day

    Investigational medicinal product name
    PR5
    Investigational medicinal product code
    A10BJ02
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1,8 milligram/day

    Investigational medicinal product name
    PR6
    Investigational medicinal product code
    A10BJ06
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0,14 milligram/day

    Investigational medicinal product name
    PR7
    Investigational medicinal product code
    A10BH01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 milligram/day

    Investigational medicinal product name
    PR8
    Investigational medicinal product code
    A10BH05
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 milligram/day

    Investigational medicinal product name
    PR9
    Investigational medicinal product code
    A10BX02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    16 milligram/day

    Investigational medicinal product name
    PR10
    Investigational medicinal product code
    A10BG03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    45 milligram/day

    Investigational medicinal product name
    PR11
    Investigational medicinal product code
    A10BF01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 milligram/day

    Investigational medicinal product name
    PR12
    Investigational medicinal product code
    A10BB07
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 milligram/day

    Investigational medicinal product name
    PR13
    Investigational medicinal product code
    A10BB12
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 milligram/day

    Investigational medicinal product name
    PR14
    Investigational medicinal product code
    C09AA02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 milligram/day

    Investigational medicinal product name
    PR15
    Investigational medicinal product code
    C09AA01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 milligram/day

    Investigational medicinal product name
    PR16
    Investigational medicinal product code
    C09AA03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    80 milligram/day

    Investigational medicinal product name
    PR17
    Investigational medicinal product code
    C09AA04
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 milligram/day

    Investigational medicinal product name
    PR18
    Investigational medicinal product code
    C09AA05
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 milligram/day

    Investigational medicinal product name
    PR19
    Investigational medicinal product code
    C09CA06
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    32 milligram/day

    Investigational medicinal product name
    PR20
    Investigational medicinal product code
    C09CA01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 milligram/day

    Investigational medicinal product name
    PR21
    Investigational medicinal product code
    C09CA03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    320 milligram/day

    Investigational medicinal product name
    PR22
    Investigational medicinal product code
    C09CA04
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 milligram/day

    Investigational medicinal product name
    PR23
    Investigational medicinal product code
    C09CA02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600 milligram/day

    Investigational medicinal product name
    PR24
    Investigational medicinal product code
    C09CA07
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    80 milligram/day

    Investigational medicinal product name
    PR25
    Investigational medicinal product code
    C07AB02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 milligram/day

    Investigational medicinal product name
    PR26
    Investigational medicinal product code
    C07AB03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 milligram/day

    Investigational medicinal product name
    PR27
    Investigational medicinal product code
    C07AB07
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 milligram/day

    Investigational medicinal product name
    PR28
    Investigational medicinal product code
    C03AA01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 milligram/day

    Investigational medicinal product name
    PR29
    Investigational medicinal product code
    C03AA03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 milligram/day

    Investigational medicinal product name
    PR30
    Investigational medicinal product code
    C03CC01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    240 milligram/day

    Investigational medicinal product name
    PR31
    Investigational medicinal product code
    C03DA01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 milligram/day

    Investigational medicinal product name
    PR32
    Investigational medicinal product code
    C03DA04
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 milligram/day

    Investigational medicinal product name
    PR33
    Investigational medicinal product code
    C08CA01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 milligram/day

    Investigational medicinal product name
    PR34
    Investigational medicinal product code
    C08CA02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 milligram/day

    Investigational medicinal product name
    PR35
    Investigational medicinal product code
    C08CA05
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    80 milligram/day

    Investigational medicinal product name
    PR36
    Investigational medicinal product code
    C08DA01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    480 milligram/day

    Investigational medicinal product name
    PR37
    Investigational medicinal product code
    C08DB01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    360 milligram/day

    Investigational medicinal product name
    PR38
    Investigational medicinal product code
    C10AA01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    80 milligram/day

    Investigational medicinal product name
    PR39
    Investigational medicinal product code
    C10AA03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 milligram/day

    Investigational medicinal product name
    PR40
    Investigational medicinal product code
    C10AA05
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    80 milligram/day

    Investigational medicinal product name
    PR41
    Investigational medicinal product code
    C10AA07
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 milligram/day

    Investigational medicinal product name
    PR42
    Investigational medicinal product code
    C10AX09
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 milligram/day

    Investigational medicinal product name
    PR43
    Investigational medicinal product code
    C10AB02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600 milligram/day

    Investigational medicinal product name
    PR44
    Investigational medicinal product code
    C10AB04
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1200 milligram/day

    Investigational medicinal product name
    PR45
    Investigational medicinal product code
    C10AB05
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 milligram/day

    Investigational medicinal product name
    PR46
    Investigational medicinal product code
    C10AC01
    Other name
    Pharmaceutical forms
    Tablet, Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    24 gram/day

    Investigational medicinal product name
    PR47
    Investigational medicinal product code
    C10AC02
    Other name
    Pharmaceutical forms
    Tablet, Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    30 gram/day

    Arm title
    		 Control
    Arm description
    		 Usual care
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Intervention Control
    Started
    5
    6
    Completed
    5
    4
    Not completed
    0
    2
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Intervention consisting of a Mediterranean diet, an individualized physical training program and optimal pharmacological treatment for T2D.

    Reporting group title
    Control
    Reporting group description
    		 Usual care

    Reporting group values
    		 Intervention Control Total
    Number of subjects
    		 5 6 11
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 5 6 11
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 3 4
        Male
    		 4 3 7

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Intervention consisting of a Mediterranean diet, an individualized physical training program and optimal pharmacological treatment for T2D.

    Reporting group title
    Control
    Reporting group description
    		 Usual care

    Primary: Feasibility: recruitment rate

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    End point title
    		 Feasibility: recruitment rate [1]
    End point description
    Recruitment rate is assessed as the number of participants recruited during a specific time period.
    End point type
    Primary
    End point timeframe
    After study completion
    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: We have performed a feasibility study with the aim to assess recruitment rate, retention rate, and acceptance. These endpoints are evaluated by numbers, proportions, and interviews, but not by using standard statistical methods.
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    6
    Units: number
    5
    6
    No statistical analyses for this end point

    Primary: Feasibility: retention rate

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    End point title
    		 Feasibility: retention rate [2]
    End point description
    Retention rate is assessed as the number of participants remaining in the study at 12 months
    End point type
    Primary
    End point timeframe
    After study completion
    Notes
    [2] - 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: We have performed a feasibility study with the aim to assess recruitment rate, retention rate, and acceptance. These endpoints are evaluated by numbers, proportions, and interviews, but not by using standard statistical methods.
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    5
    Units: number
    5
    5
    No statistical analyses for this end point

    Primary: Feasibility: adherence rate

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    End point title
    		 Feasibility: adherence rate [3]
    End point description
    End point type
    Primary
    End point timeframe
    At 0, 6 and 12 months
    Notes
    [3] - 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: We have performed a feasibility study with the aim to assess recruitment rate, retention rate, and acceptance. These endpoints are evaluated by numbers, proportions, and interviews, but not by using standard statistical methods.
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    5
    Units: number
    5
    5
    No statistical analyses for this end point

    Primary: Feasibility: acceptance rate

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    End point title
    		 Feasibility: acceptance rate [4]
    End point description
    Acceptance is assessed by interviews
    End point type
    Primary
    End point timeframe
    Between 6 weeks after study start and the 6-month visit, and at the end of the study
    Notes
    [4] - 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: We have performed a feasibility study with the aim to assess recruitment rate, retention rate, and acceptance. These endpoints are evaluated by numbers, proportions, and interviews, but not by using standard statistical methods.
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    5
    Units: number
    5
    5
    No statistical analyses for this end point

    Secondary: Metabolic control: Blood pressure

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    End point title
    		 Metabolic control: Blood pressure
    End point description
    Metabolic control: Blood pressure
    End point type
    Secondary
    End point timeframe
    At 0, 3, 6, 9 and 12 months
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    4
    Units: number
    5
    4
    No statistical analyses for this end point

    Secondary: Estimated food intake: Recorded intake of approximately 20 food items over 4 consecutive days.

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    End point title
    		 Estimated food intake: Recorded intake of approximately 20 food items over 4 consecutive days.
    End point description
    Estimated food intake: Recorded intake of approximately 20 food items over 4 consecutive days.
    End point type
    Secondary
    End point timeframe
    At 0, 6 and 12 months
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    4
    Units: number
    5
    4
    No statistical analyses for this end point

    Secondary: Cardiovascular fitness: Aerobic capacity (VO2max) estimated with the Ekblom-Bak test.

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    End point title
    		 Cardiovascular fitness: Aerobic capacity (VO2max) estimated with the Ekblom-Bak test.
    End point description
    Cardiovascular fitness: Aerobic capacity (VO2max) estimated with the Ekblom-Bak test.
    End point type
    Secondary
    End point timeframe
    At 0, 6 and 12 months.
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    4
    Units: number
    5
    4
    No statistical analyses for this end point

    Secondary: Physical activity and sedentary behavior: The accelerometer activPAL will be used to measure physical activity and sedentary behavior

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    End point title
    		 Physical activity and sedentary behavior: The accelerometer activPAL will be used to measure physical activity and sedentary behavior
    End point description
    Physical activity and sedentary behavior: The accelerometer activPAL will be used to measure physical activity and sedentary behavior
    End point type
    Secondary
    End point timeframe
    At 0, 6 and 12 months
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    4
    Units: number
    5
    4
    No statistical analyses for this end point

    Secondary: Grip strength: Grip strength in the left and right hand measured with a hand dynamometer.

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    End point title
    		 Grip strength: Grip strength in the left and right hand measured with a hand dynamometer.
    End point description
    Grip strength: Grip strength in the left and right hand measured with a hand dynamometer.
    End point type
    Secondary
    End point timeframe
    At 0, 6 and 12 months.
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    4
    Units: number
    5
    4
    No statistical analyses for this end point

    Secondary: Leg strength: Functional leg strength and endurance measured using the Chair Stand Test

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    End point title
    		 Leg strength: Functional leg strength and endurance measured using the Chair Stand Test
    End point description
    Leg strength: Functional leg strength and endurance measured using the Chair Stand Test
    End point type
    Secondary
    End point timeframe
    At 0, 6 and 12 months.
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    4
    Units: number
    5
    4
    No statistical analyses for this end point

    Secondary: Exercise Self-Efficacy Scale (ESES): To investigate participants selfefficacy regarding performing exercise.

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    End point title
    		 Exercise Self-Efficacy Scale (ESES): To investigate participants selfefficacy regarding performing exercise.
    End point description
    Exercise Self-Efficacy Scale (ESES): To investigate participants selfefficacy regarding performing exercise.
    End point type
    Secondary
    End point timeframe
    At 0, 6 and 12 months
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    4
    Units: number
    5
    4
    No statistical analyses for this end point

    Secondary: Exercise Regulations Questionnaire (BREQ-2): To investigate participants motivation to exercise.

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    End point title
    		 Exercise Regulations Questionnaire (BREQ-2): To investigate participants motivation to exercise.
    End point description
    Exercise Regulations Questionnaire (BREQ-2): To investigate participants motivation to exercise.
    End point type
    Secondary
    End point timeframe
    At 0, 6 and 12 months
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    4
    Units: number
    5
    4
    No statistical analyses for this end point

    Secondary: Cognitive function: Evaluated with standardized neuropsychological tests.

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    End point title
    		 Cognitive function: Evaluated with standardized neuropsychological tests.
    End point description
    Cognitive function: Evaluated with standardized neuropsychological tests.
    End point type
    Secondary
    End point timeframe
    At 0 and 12 months
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    4
    Units: number
    5
    4
    No statistical analyses for this end point

    Secondary: Metabolic control: Blood levels of HbA1c and lipids, height, body weight, BMI and waist circumference.

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    End point title
    		 Metabolic control: Blood levels of HbA1c and lipids, height, body weight, BMI and waist circumference.
    End point description
    Metabolic control: Blood levels of HbA1c and lipids, height, body weight, BMI and waist circumference.
    End point type
    Secondary
    End point timeframe
    At 0, 6 and 12 months
    End point values
    		 Intervention Control
    Number of subjects analysed
    5
    4
    Units: units
    5
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From study start (after randomisation) until the last study visit
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Intervention consisting of a Mediterranean diet, an individualized physical training program and optimal pharmacological treatment for T2D

    Reporting group title
    Control
    Reporting group description
    		 Usual care

    Serious adverse events
    		 Intervention Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    Sudden death
    Additional description: Traffic accident
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Intervention Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    5 / 5 (100.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 5 (0.00%)
         occurrences all number
    5
    0
    Dizziness
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 5 (40.00%)
         occurrences all number
    1
    3
    Syncope
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Pain
    Additional description: Pain in trunk, hip, hand or finger
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Fever
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Oral pain
    Additional description: Oral pain after dental surgery
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Postnasal drip
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Dyspnea
    Additional description: Breathlessness
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 5 (20.00%)
         occurrences all number
    2
    1
    Other
    Additional description: Bursit
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Vaginal infection
    Additional description: vaginal yeast infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Abdominal infection
    Additional description: Stomach sickness
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    Lung infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    3
    0

    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
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