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ID

12841

Description

Study of Metamucil on Blood Glucose and HbA1c in Type II NIDDM Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01582282

Lien

https://clinicaltrials.gov/show/NCT01582282

Mots-clés

  1. 29/12/2015 29/12/2015 -
Téléchargé le

29 décembre 2015

DOI

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Licence

Creative Commons BY 4.0

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    Eligibility Non-Insulin-dependent Diabetes Mellitus NCT01582282

    Eligibility Non-Insulin-dependent Diabetes Mellitus NCT01582282

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    have a clinical diagnosis of type ii diabetes mellitus, controlled by diet and/or second generation oral hypoglycemic drugs, with the onset of the disease after age 35.
    Description

    have a clinical diagnosis of type ii diabetes mellitus, controlled by diet and/or second generation oral hypoglycemic drugs, with the onset of the disease after age 35.

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0011860 (Diabetes Mellitus, Non-Insulin-Dependent)
    SNOMED
    44054006
    UMLS CUI [2]
    C0012159 (Diet therapy)
    UMLS CUI [3]
    C0359086 (oral hypoglycemics)
    UMLS CUI [4]
    C0206132 (Age of Onset)
    are between 0 and 50% above "normal" body weight (adjusted by frame) according to the metropolitan life insurance tables
    Description

    are between 0 and 50% above "normal" body weight (adjusted by frame) according to the metropolitan life insurance tables

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    are male or female, aged 36-80 years with a diagnosis made at least 1 year prior to enrollment.
    Description

    are male or female, aged 36-80 years with a diagnosis made at least 1 year prior to enrollment.

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    have an hba1c level between 6 and 10%
    Description

    have an hba1c level between 6 and 10%

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019018 (Glycosylated hemoglobin A)
    LOINC
    LP16413-4
    have a fasting serum glucose level between 120-220 mg/dl and not vary by more than ±20% during the month prior to entering the treatment phase and hba1c levels not vary by more than ±10% during the month prior to entering the treatment phase. serum glucose level must have been between 120-220mg/dl and the subject's hba1c between 6 and 10% at week 0.
    Description

    have a fasting serum glucose level between 120-220 mg/dl and not vary by more than ±20% during the month prior to entering the treatment phase and hba1c levels not vary by more than ±10% during the month prior to entering the treatment phase. serum glucose level must have been between 120-220mg/dl and the subject's hba1c between 6 and 10% at week 0.

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0017725 (glucose)
    SNOMED
    111138002
    UMLS CUI [2]
    C0019018 (Glycosylated hemoglobin A)
    LOINC
    LP16413-4
    have been on a "stable" diet consistent with ada-recommended dietary guidelines with intake of total dietary fiber < 15g/1000 calories and were willing to maintain this diet during the 20-week study.
    Description

    have been on a "stable" diet consistent with ada-recommended dietary guidelines with intake of total dietary fiber < 15g/1000 calories and were willing to maintain this diet during the 20-week study.

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0012159 (Diet therapy)
    have maintained a constant body weight (±5%) during the month prior to entering the treatment phase
    Description

    have maintained a constant body weight (±5%) during the month prior to entering the treatment phase

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    have a condition that would interfere with evaluation
    Description

    have a condition that would interfere with evaluation

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)

    Similar models

    Eligibility Non-Insulin-dependent Diabetes Mellitus NCT01582282

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    diabetes mellitus
    Item
    have a clinical diagnosis of type ii diabetes mellitus, controlled by diet and/or second generation oral hypoglycemic drugs, with the onset of the disease after age 35.
    boolean
    C0011860 (UMLS CUI [1])
    C0012159 (UMLS CUI [2])
    C0359086 (UMLS CUI [3])
    C0206132 (UMLS CUI [4])
    body weight
    Item
    are between 0 and 50% above "normal" body weight (adjusted by frame) according to the metropolitan life insurance tables
    boolean
    C0005910 (UMLS CUI [1])
    age
    Item
    are male or female, aged 36-80 years with a diagnosis made at least 1 year prior to enrollment.
    boolean
    C0001779 (UMLS CUI [1])
    HBA1c level
    Item
    have an hba1c level between 6 and 10%
    boolean
    C0019018 (UMLS CUI [1])
    serum glucose level
    Item
    have a fasting serum glucose level between 120-220 mg/dl and not vary by more than ±20% during the month prior to entering the treatment phase and hba1c levels not vary by more than ±10% during the month prior to entering the treatment phase. serum glucose level must have been between 120-220mg/dl and the subject's hba1c between 6 and 10% at week 0.
    boolean
    C0017725 (UMLS CUI [1])
    C0019018 (UMLS CUI [2])
    diet
    Item
    have been on a "stable" diet consistent with ada-recommended dietary guidelines with intake of total dietary fiber < 15g/1000 calories and were willing to maintain this diet during the 20-week study.
    boolean
    C0012159 (UMLS CUI [1])
    constant body weight
    Item
    have maintained a constant body weight (±5%) during the month prior to entering the treatment phase
    boolean
    C0005910 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    interfering condition
    Item
    have a condition that would interfere with evaluation
    boolean
    C0220825 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])

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