ID

31243

Descrição

Impact of GBS on CVD in Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00787670

Link

https://clinicaltrials.gov/show/NCT00787670

Palavras-chave

Versões (1)
  1. 01/08/2018 01/08/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

1 de agosto de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Obesity NCT00787670

Inglês

Eligibility Obesity NCT00787670

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00787670
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of t2dm diabetes mellitus with hba1c ≤ 10.0%
Descrição

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
current regular use of insulin
Descrição

Insulin use Regular

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0240016
UMLS CUI [1,2]
C0205272
current regular use of oral hypoglycemic medication.
Descrição

Oral hypoglycemic Use Regular

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0205272
documented diabetes by current ada criteria (98).
Descrição

Diabetes Mellitus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011849
body mass index ≥ 35 kg/m2 in accord with the 1991 nih obesity surgery consensus conference criteria and stable weight for the previous 3 months
Descrição

Body mass index | Stable body weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0517386
age between 18-60 years old.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
ability and willingness to provide informed consent.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
no expectation that subject will be moving out of the area of the clinical center during the next 12 months.
Descrição

Absence Relocation of home Remote Medical center

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C2699029
UMLS CUI [1,3]
C0205157
UMLS CUI [1,4]
C0565990
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of cvd defined as: cad, electrocardiographic criteria for past myocardial infarction(s), ischemic stroke, peripheral artery bypass surgery, percutaneous transluminal angioplasty, or amputation because of atherosclerotic disease
Descrição

Cardiovascular Diseases | Coronary Artery Disease | Myocardial Infarction Electrocardiography | Ischemic stroke | Peripheral arterial bypass | Percutaneous Transluminal Angioplasty | Amputation Due to Atherosclerosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C1956346
UMLS CUI [3,1]
C0027051
UMLS CUI [3,2]
C1623258
UMLS CUI [4]
C0948008
UMLS CUI [5]
C0190961
UMLS CUI [6]
C2936666
UMLS CUI [7,1]
C0002688
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C0004153
significant non-diabetic co-morbidity affecting life expectancy (e.g., malignancy)
Descrição

Comorbidity Affecting Life Expectancy | Exception Diabetes Mellitus | Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0023671
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011849
UMLS CUI [3]
C0006826
significant other co-morbidities (e.g. psychiatric disorder) that results in ineligibility for gastric bypass surgery
Descrição

Comorbidity Resulting in Ineligibility Gastric Bypass | Mental disorders Resulting in Ineligibility Gastric Bypass

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C1512714
UMLS CUI [1,4]
C0017125
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C1512714
UMLS CUI [2,4]
C0017125
pregnancy or planning pregnancy
Descrição

Pregnancy | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
severe dyslipidemia (triglycerides >600 mg/dl or cholesterol >350 mg/dl)
Descrição

Dyslipidemia Severe | Triglycerides measurement | Cholesterol measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242339
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0202236
UMLS CUI [3]
C0201950
uncontrolled hypertension
Descrição

Uncontrolled hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
smoking
Descrição

Tobacco use

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0543414
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Similar models

Eligibility Obesity NCT00787670

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00787670
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement
Item
clinical diagnosis of t2dm diabetes mellitus with hba1c ≤ 10.0%
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Insulin use Regular
Item
current regular use of insulin
boolean
C0240016 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Oral hypoglycemic Use Regular
Item
current regular use of oral hypoglycemic medication.
boolean
C0359086 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Diabetes Mellitus
Item
documented diabetes by current ada criteria (98).
boolean
C0011849 (UMLS CUI [1])
Body mass index | Stable body weight
Item
body mass index ≥ 35 kg/m2 in accord with the 1991 nih obesity surgery consensus conference criteria and stable weight for the previous 3 months
boolean
C1305855 (UMLS CUI [1])
C0517386 (UMLS CUI [2])
Age
Item
age between 18-60 years old.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
ability and willingness to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Absence Relocation of home Remote Medical center
Item
no expectation that subject will be moving out of the area of the clinical center during the next 12 months.
boolean
C0332197 (UMLS CUI [1,1])
C2699029 (UMLS CUI [1,2])
C0205157 (UMLS CUI [1,3])
C0565990 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Diseases | Coronary Artery Disease | Myocardial Infarction Electrocardiography | Ischemic stroke | Peripheral arterial bypass | Percutaneous Transluminal Angioplasty | Amputation Due to Atherosclerosis
Item
presence of cvd defined as: cad, electrocardiographic criteria for past myocardial infarction(s), ischemic stroke, peripheral artery bypass surgery, percutaneous transluminal angioplasty, or amputation because of atherosclerotic disease
boolean
C0007222 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0027051 (UMLS CUI [3,1])
C1623258 (UMLS CUI [3,2])
C0948008 (UMLS CUI [4])
C0190961 (UMLS CUI [5])
C2936666 (UMLS CUI [6])
C0002688 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0004153 (UMLS CUI [7,3])
Comorbidity Affecting Life Expectancy | Exception Diabetes Mellitus | Malignant Neoplasms
Item
significant non-diabetic co-morbidity affecting life expectancy (e.g., malignancy)
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3])
Comorbidity Resulting in Ineligibility Gastric Bypass | Mental disorders Resulting in Ineligibility Gastric Bypass
Item
significant other co-morbidities (e.g. psychiatric disorder) that results in ineligibility for gastric bypass surgery
boolean
C0009488 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
C0017125 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C1512714 (UMLS CUI [2,3])
C0017125 (UMLS CUI [2,4])
Pregnancy | Pregnancy, Planned
Item
pregnancy or planning pregnancy
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Dyslipidemia Severe | Triglycerides measurement | Cholesterol measurement
Item
severe dyslipidemia (triglycerides >600 mg/dl or cholesterol >350 mg/dl)
boolean
C0242339 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0202236 (UMLS CUI [2])
C0201950 (UMLS CUI [3])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Tobacco use
Item
smoking
boolean
C0543414 (UMLS CUI [1])
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