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ID

16100

Beschrijving

Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02315495

Link

https://clinicaltrials.gov/show/NCT02315495

Trefwoorden

  1. 29-06-16 29-06-16 -
Geüploaded op

29 juni 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Type 2 Diabetes NCT02315495

    Eligibility Type 2 Diabetes NCT02315495

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    type 2 diabetes (world health organisation (who) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin)
    Beschrijving

    Diabetes Mellitus, Non-Insulin-Dependent Diabetic on diet only | Oral hypoglycemic Absent | Insulin Absent

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0011860 (Diabetes Mellitus, Non-Insulin-Dependent)
    SNOMED
    44054006
    UMLS CUI [1,2]
    C0421246 (Diabetic on diet only)
    SNOMED
    170745003
    UMLS CUI [2,1]
    C0359086 (oral hypoglycemics)
    UMLS CUI [2,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [3,1]
    C0021641 (Insulin)
    SNOMED
    39487003
    LOINC
    LP70329-5
    UMLS CUI [3,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    body mass index (bmi) 20 - 40 kg/m2
    Beschrijving

    Body mass index

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1305855 (Body mass index)
    SNOMED
    60621009
    LOINC
    LP35925-4
    age 18 - 70 years
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)
    Beschrijving

    Gender | Postmenopausal state | control Menstrual cycle Effect Gut Hormone secretion

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2]
    C0232970 (Postmenopausal state)
    SNOMED
    76498008
    UMLS CUI [3,1]
    C0243148 (control aspects)
    UMLS CUI [3,2]
    C0025329 (Menstrual cycle)
    SNOMED
    78456001
    UMLS CUI [3,3]
    C1280500 (Effect)
    SNOMED
    253861007
    UMLS CUI [3,4]
    C0699819 (Gut)
    UMLS CUI [3,5]
    C0312431 (Hormone secretion)
    SNOMED
    60877009
    glycated haemoglobin a1c (hba1c) ≥ 6.0% and ≤ 7.9%
    Beschrijving

    Hemoglobin A1c measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0474680 (Hemoglobin A1c measurement)
    SNOMED
    43396009
    haemoglobin above the lower limit of the normal range (i.e. >135g/l for men and 115g/l for women), and ferritin above the lower limit of normal (i.e. >10mcg/l)
    Beschrijving

    Hemoglobin measurement | Gender | Ferritin measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0518015 (Hemoglobin measurement)
    UMLS CUI [2]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [3]
    C0373607 (Ferritin measurement)
    SNOMED
    489004
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    use of any medication that may influence gastrointestinal motor function, body weight or appetite
    Beschrijving

    Pharmaceutical Preparations Affecting function gastrointestinal motor | Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting appetite

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0392760 (Affecting)
    SNOMED
    247591002
    UMLS CUI [1,3]
    C0031843 (physiological aspects)
    UMLS CUI [1,4]
    C0521362 (gastrointestinal)
    UMLS CUI [1,5]
    C1513492 (motor movement)
    UMLS CUI [2,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [2,2]
    C0392760 (Affecting)
    SNOMED
    247591002
    UMLS CUI [2,3]
    C0005910 (Body Weight)
    SNOMED
    27113001
    UMLS CUI [3,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [3,2]
    C0392760 (Affecting)
    SNOMED
    247591002
    UMLS CUI [3,3]
    C0003618 (Desire for food)
    SNOMED
    33911006
    evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
    Beschrijving

    Drug abuse | Alcohol consumption Unit per Gram per Day | Cigarette smoker Number of cigarettes per day

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0013146 (Drug abuse)
    SNOMED
    26416006
    LOINC
    LP36310-8
    UMLS CUI [2,1]
    C0001948 (Alcohol consumption)
    SNOMED
    897148007
    LOINC
    MTHU047472
    UMLS CUI [2,2]
    C2349072 (Unit per Gram per Day)
    UMLS CUI [3,1]
    C0337667 (Cigarette smoker (finding))
    SNOMED
    65568007
    UMLS CUI [3,2]
    C3694146 (number of cigarettes per day)
    history of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
    Beschrijving

    Gastrointestinal Diseases | Symptoms Significant Upper Gastrointestinal Tract | Symptoms Significant Lower Gastrointestinal Tract | Pancreatitis | Gastrointestinal Surgical Procedure | Appendectomy Uncomplicated | Cholecystectomy Uncomplicated

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0017178 (Gastrointestinal Diseases)
    SNOMED
    25374005
    UMLS CUI [2,1]
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    UMLS CUI [2,2]
    C0750502 (Significant)
    SNOMED
    386134007
    LOINC
    LA28474-7
    UMLS CUI [2,3]
    C3203348 (Upper Gastrointestinal Tract)
    SNOMED
    62834003
    UMLS CUI [3,1]
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    UMLS CUI [3,2]
    C0750502 (Significant)
    SNOMED
    386134007
    LOINC
    LA28474-7
    UMLS CUI [3,3]
    C0226875 (Lower Gastrointestinal Tract)
    SNOMED
    5668004
    UMLS CUI [4]
    C0030305 (Pancreatitis)
    SNOMED
    75694006
    LOINC
    LA15860-2
    UMLS CUI [5]
    C0524722 (Gastrointestinal Surgical Procedure)
    UMLS CUI [6,1]
    C0003611 (Appendectomy)
    SNOMED
    80146002
    UMLS CUI [6,2]
    C0443334 (Uncomplicated)
    SNOMED
    263914008
    UMLS CUI [7,1]
    C0008320 (Cholecystectomy procedure)
    SNOMED
    38102005
    LOINC
    LA14290-3
    UMLS CUI [7,2]
    C0443334 (Uncomplicated)
    SNOMED
    263914008
    other significant illness, including epilepsy, cardiovascular or respiratory disease
    Beschrijving

    Illness Significant | Epilepsy | Cardiovascular Diseases | Respiration Disorders

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423 (Illness (finding))
    SNOMED
    39104002
    UMLS CUI [1,2]
    C0750502 (Significant)
    SNOMED
    386134007
    LOINC
    LA28474-7
    UMLS CUI [2]
    C0014544 (Epilepsy)
    SNOMED
    84757009
    LOINC
    MTHU020586
    UMLS CUI [3]
    C0007222 (Cardiovascular Diseases)
    SNOMED
    49601007
    UMLS CUI [4]
    C0035204 (Respiration Disorders)
    SNOMED
    50043002
    LOINC
    LA20369-7
    autonomic nerve damage (as assessed by standardised cardiovascular reflex tests [36])
    Beschrijving

    Autonomic nerve injury

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0560614 (Autonomic nerve injury)
    SNOMED
    282746001
    impaired renal or liver function (as assessed by calculated creatinine clearance < 90 ml/min or abnormal liver function tests (> 2 times upper limit of normal range))
    Beschrijving

    Renal Insufficiency | Liver Dysfunction | Creatinine clearance measurement | Liver function tests abnormal

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1565489 (Renal Insufficiency)
    SNOMED
    236423003
    UMLS CUI [2]
    C0086565 (Liver Dysfunction)
    SNOMED
    75183008
    UMLS CUI [3]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    UMLS CUI [4]
    C0151766 (Liver function tests abnormal finding)
    SNOMED
    166603001
    allergy to vildagliptin or any other 'gliptin'
    Beschrijving

    Hypersensitivity vildagliptin

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C1570906 (vildagliptin)
    SNOMED
    428611002
    donation of blood within the previous 3 months
    Beschrijving

    Blood Donation

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0005794 (Blood Donation)
    participation in any other research studies within the previous 3 months
    Beschrijving

    Study Subject Participation Status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    females who are pre-menopausal
    Beschrijving

    Premenopause

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0206158 (Premenopause)
    inability to give informed consent
    Beschrijving

    Informed Consent Unable

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C1299582 (Unable)
    SNOMED
    371151008
    LOINC
    LA13868-7
    vegetarians
    Beschrijving

    Vegetarian

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0042441 (Vegetarian (finding)

    Similar models

    Eligibility Type 2 Diabetes NCT02315495

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diabetes Mellitus, Non-Insulin-Dependent Diabetic on diet only | Oral hypoglycemic Absent | Insulin Absent
    Item
    type 2 diabetes (world health organisation (who) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin)
    boolean
    C0011860 (UMLS CUI [1,1])
    C0421246 (UMLS CUI [1,2])
    C0359086 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0021641 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    Body mass index
    Item
    body mass index (bmi) 20 - 40 kg/m2
    boolean
    C1305855 (UMLS CUI [1])
    Age
    Item
    age 18 - 70 years
    boolean
    C0001779 (UMLS CUI [1])
    Gender | Postmenopausal state | control Menstrual cycle Effect Gut Hormone secretion
    Item
    males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)
    boolean
    C0079399 (UMLS CUI [1])
    C0232970 (UMLS CUI [2])
    C0243148 (UMLS CUI [3,1])
    C0025329 (UMLS CUI [3,2])
    C1280500 (UMLS CUI [3,3])
    C0699819 (UMLS CUI [3,4])
    C0312431 (UMLS CUI [3,5])
    Hemoglobin A1c measurement
    Item
    glycated haemoglobin a1c (hba1c) ≥ 6.0% and ≤ 7.9%
    boolean
    C0474680 (UMLS CUI [1])
    Hemoglobin measurement | Gender | Ferritin measurement
    Item
    haemoglobin above the lower limit of the normal range (i.e. >135g/l for men and 115g/l for women), and ferritin above the lower limit of normal (i.e. >10mcg/l)
    boolean
    C0518015 (UMLS CUI [1])
    C0079399 (UMLS CUI [2])
    C0373607 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Pharmaceutical Preparations Affecting function gastrointestinal motor | Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting appetite
    Item
    use of any medication that may influence gastrointestinal motor function, body weight or appetite
    boolean
    C0013227 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0031843 (UMLS CUI [1,3])
    C0521362 (UMLS CUI [1,4])
    C1513492 (UMLS CUI [1,5])
    C0013227 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0005910 (UMLS CUI [2,3])
    C0013227 (UMLS CUI [3,1])
    C0392760 (UMLS CUI [3,2])
    C0003618 (UMLS CUI [3,3])
    Drug abuse | Alcohol consumption Unit per Gram per Day | Cigarette smoker Number of cigarettes per day
    Item
    evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
    boolean
    C0013146 (UMLS CUI [1])
    C0001948 (UMLS CUI [2,1])
    C2349072 (UMLS CUI [2,2])
    C0337667 (UMLS CUI [3,1])
    C3694146 (UMLS CUI [3,2])
    Gastrointestinal Diseases | Symptoms Significant Upper Gastrointestinal Tract | Symptoms Significant Lower Gastrointestinal Tract | Pancreatitis | Gastrointestinal Surgical Procedure | Appendectomy Uncomplicated | Cholecystectomy Uncomplicated
    Item
    history of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
    boolean
    C0017178 (UMLS CUI [1])
    C1457887 (UMLS CUI [2,1])
    C0750502 (UMLS CUI [2,2])
    C3203348 (UMLS CUI [2,3])
    C1457887 (UMLS CUI [3,1])
    C0750502 (UMLS CUI [3,2])
    C0226875 (UMLS CUI [3,3])
    C0030305 (UMLS CUI [4])
    C0524722 (UMLS CUI [5])
    C0003611 (UMLS CUI [6,1])
    C0443334 (UMLS CUI [6,2])
    C0008320 (UMLS CUI [7,1])
    C0443334 (UMLS CUI [7,2])
    Illness Significant | Epilepsy | Cardiovascular Diseases | Respiration Disorders
    Item
    other significant illness, including epilepsy, cardiovascular or respiratory disease
    boolean
    C0221423 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    C0014544 (UMLS CUI [2])
    C0007222 (UMLS CUI [3])
    C0035204 (UMLS CUI [4])
    Autonomic nerve injury
    Item
    autonomic nerve damage (as assessed by standardised cardiovascular reflex tests [36])
    boolean
    C0560614 (UMLS CUI [1])
    Renal Insufficiency | Liver Dysfunction | Creatinine clearance measurement | Liver function tests abnormal
    Item
    impaired renal or liver function (as assessed by calculated creatinine clearance < 90 ml/min or abnormal liver function tests (> 2 times upper limit of normal range))
    boolean
    C1565489 (UMLS CUI [1])
    C0086565 (UMLS CUI [2])
    C0373595 (UMLS CUI [3])
    C0151766 (UMLS CUI [4])
    Hypersensitivity vildagliptin
    Item
    allergy to vildagliptin or any other 'gliptin'
    boolean
    C0020517 (UMLS CUI [1,1])
    C1570906 (UMLS CUI [1,2])
    Blood Donation
    Item
    donation of blood within the previous 3 months
    boolean
    C0005794 (UMLS CUI [1])
    Study Subject Participation Status
    Item
    participation in any other research studies within the previous 3 months
    boolean
    C2348568 (UMLS CUI [1])
    Premenopause
    Item
    females who are pre-menopausal
    boolean
    C0206158 (UMLS CUI [1])
    Informed Consent Unable
    Item
    inability to give informed consent
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    Vegetarian
    Item
    vegetarians
    boolean
    C0042441 (UMLS CUI [1])

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