ID

33045

Beskrivning

TODAY Genetics Study; ODM derived from: https://clinicaltrials.gov/show/NCT00722397

Länk

https://clinicaltrials.gov/show/NCT00722397

Nyckelord

Versioner (2)
  1. 2018-11-25 2018-11-25 -
  2. 2021-09-17 2021-09-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 november 2018

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00722397

Engelsk

Eligibility Type 2 Diabetes NCT00722397

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diabetes by ada criteria (laboratory determinations of fasting glucose ≥ 126 mg/dl, random glucose ≥ 200 mg/dl, or two-hour oral glucose tolerance test (ogtt) glucose ≥
Beskrivning

Diabetes Mellitus | Glucose measurement, fasting | Glucose measurement, random | Oral Glucose Tolerance Test

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0202045
UMLS CUI [3]
C0202046
UMLS CUI [4]
C0029161
200 mg/dl) documented and confirmed in medical record or a laboratory determination of hba1c ≥ 7%. for asymptomatic patients diagnosed with diabetes with a normal fasting glucose but an elevated two-hour glucose during an ogtt, the hba1c must be ≥
Beskrivning

Hemoglobin A1c measurement | Patients Asymptomatic | Diabetes Mellitus | Fasting blood glucose normal | 2-Hour Postprandial Glucose Elevated Oral Glucose Tolerance Test

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0231221
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0948682
UMLS CUI [5,1]
C4331814
UMLS CUI [5,2]
C3163633
UMLS CUI [5,3]
C0029161
bmi ≥ 85th percentile documented at time of diagnosis or at screening.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
age < 18 at time of diagnosis.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
signed informed consent and assent forms as appropriate.
Beskrivning

Informed Consent | Forms Assent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0009797
UMLS CUI [2,2]
C1879749
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
Beskrivning

Genetic syndrome Affecting Glucose tolerance | Hereditary Disease Affecting Glucose tolerance | Exception Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0567439
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0178665
UMLS CUI [2,1]
C0019247
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0178665
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0011849
patient on medication known to affect glucose tolerance, insulin sensitivity or secretion within 60 days of the time of diagnosis. if diagnosis is confirmed after the patient has been off the medication for 60 days, the patient may be included. exclusionary medications include but are not limited to
Beskrivning

Pharmaceutical Preparations Affecting Glucose tolerance | Pharmaceutical Preparations Affecting Insulin Sensitivity | Pharmaceutical Preparations Affecting Insulin secretion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0178665
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0920563
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1256369
1. inhaled steroids at dose above 1000 mcg daily fluticasone equivalent,
Beskrivning

Inhaled steroids Dose U/day | Fluticasone Equivalent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0082607
UMLS CUI [2,2]
C0205163
2. oral glucocorticoids,
Beskrivning

Glucocorticoids Oral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C1527415
3. antirejection or chemotherapy agents (e.g., tacrolimus, l-asparaginase),
Beskrivning

Antirejection therapy | Chemotherapeutics | Tacrolimus | l-asparaginase

Datatyp

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0003392
UMLS CUI [3]
C0085149
UMLS CUI [4]
C0003993
4. atypical antipsychotics.
Beskrivning

Atypical antipsychotic

Datatyp

boolean

Alias
UMLS CUI [1]
C1276996
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Similar models

Eligibility Type 2 Diabetes NCT00722397

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus | Glucose measurement, fasting | Glucose measurement, random | Oral Glucose Tolerance Test
Item
diabetes by ada criteria (laboratory determinations of fasting glucose ≥ 126 mg/dl, random glucose ≥ 200 mg/dl, or two-hour oral glucose tolerance test (ogtt) glucose ≥
boolean
C0011849 (UMLS CUI [1])
C0202045 (UMLS CUI [2])
C0202046 (UMLS CUI [3])
C0029161 (UMLS CUI [4])
Hemoglobin A1c measurement | Patients Asymptomatic | Diabetes Mellitus | Fasting blood glucose normal | 2-Hour Postprandial Glucose Elevated Oral Glucose Tolerance Test
Item
200 mg/dl) documented and confirmed in medical record or a laboratory determination of hba1c ≥ 7%. for asymptomatic patients diagnosed with diabetes with a normal fasting glucose but an elevated two-hour glucose during an ogtt, the hba1c must be ≥
boolean
C0474680 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C0011849 (UMLS CUI [3])
C0948682 (UMLS CUI [4])
C4331814 (UMLS CUI [5,1])
C3163633 (UMLS CUI [5,2])
C0029161 (UMLS CUI [5,3])
Body mass index
Item
bmi ≥ 85th percentile documented at time of diagnosis or at screening.
boolean
C1305855 (UMLS CUI [1])
Age
Item
age < 18 at time of diagnosis.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Forms Assent
Item
signed informed consent and assent forms as appropriate.
boolean
C0021430 (UMLS CUI [1])
C0009797 (UMLS CUI [2,1])
C1879749 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Genetic syndrome Affecting Glucose tolerance | Hereditary Disease Affecting Glucose tolerance | Exception Diabetes Mellitus
Item
genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
boolean
C0567439 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0178665 (UMLS CUI [1,3])
C0019247 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0178665 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0011849 (UMLS CUI [3,2])
Pharmaceutical Preparations Affecting Glucose tolerance | Pharmaceutical Preparations Affecting Insulin Sensitivity | Pharmaceutical Preparations Affecting Insulin secretion
Item
patient on medication known to affect glucose tolerance, insulin sensitivity or secretion within 60 days of the time of diagnosis. if diagnosis is confirmed after the patient has been off the medication for 60 days, the patient may be included. exclusionary medications include but are not limited to
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0178665 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0920563 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1256369 (UMLS CUI [3,3])
Inhaled steroids Dose U/day | Fluticasone Equivalent
Item
1. inhaled steroids at dose above 1000 mcg daily fluticasone equivalent,
boolean
C2065041 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0082607 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
Glucocorticoids Oral
Item
2. oral glucocorticoids,
boolean
C0017710 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Antirejection therapy | Chemotherapeutics | Tacrolimus | l-asparaginase
Item
3. antirejection or chemotherapy agents (e.g., tacrolimus, l-asparaginase),
boolean
C0021079 (UMLS CUI [1])
C0003392 (UMLS CUI [2])
C0085149 (UMLS CUI [3])
C0003993 (UMLS CUI [4])
Atypical antipsychotic
Item
4. atypical antipsychotics.
boolean
C1276996 (UMLS CUI [1])
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