ID

31230

Beskrivning

Impact of Gastric Bypass Surgery on Risk of CVD in Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00444392

Länk

https://clinicaltrials.gov/show/NCT00444392

Nyckelord

Versioner (1)
  1. 2018-07-31 2018-07-31 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

31 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Obese Patients NCT00444392

Engelsk

Eligibility Obese Patients NCT00444392

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. clinical diagnosis of t2dm diabetes mellitus with hba1c ≤ 10.0%
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
any one of the following will be considered to be sufficient evidence that diabetes is present:
Beskrivning

Criteria Diabetes

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0011847
current regular use of insulin
Beskrivning

Insulin use Regular

Datatyp

boolean

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

Oral hypoglycemic Using Regular

Datatyp

boolean

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

Diabetes Documented

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011847
UMLS CUI [1,2]
C1301725
2. 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 (99).
Beskrivning

Body mass index | Stable body weight

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0517386
3. age between 18-60 years old. individuals older than 60 years of age are excluded due to their increased risk of mortality and peri-operative morbidity.
Beskrivning

Age

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
5. no expectation that subject will be moving out of the area of the clinical center during the next 24 months.
Beskrivning

Relocation of home Unlikely

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C0750558
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. 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.
Beskrivning

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

Datatyp

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]
C3495795
UMLS CUI [6]
C2936666
UMLS CUI [7,1]
C0002688
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C0004153
2. significant non-diabetic co-morbidity affecting life expectancy (e.g., malignancy).
Beskrivning

Comorbidity Affecting Life Expectancy | Malignant Neoplasms | Exception Diabetes Mellitus

Datatyp

boolean

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

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

Datatyp

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
4. pregnancy or planning pregnancy.
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

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

Dyslipidemia Severe | Triglycerides measurement | Cholesterol measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242339
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0202236
UMLS CUI [3]
C0201950
6. uncontrolled hypertension.
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
7. smoking.
Beskrivning

Tobacco use

Datatyp

boolean

Alias
UMLS CUI [1]
C0543414
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Similar models

Eligibility Obese Patients NCT00444392

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement
Item
1. clinical diagnosis of t2dm diabetes mellitus with hba1c ≤ 10.0%
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Criteria Diabetes
Item
any one of the following will be considered to be sufficient evidence that diabetes is present:
boolean
C0243161 (UMLS CUI [1,1])
C0011847 (UMLS CUI [1,2])
Insulin use Regular
Item
current regular use of insulin
boolean
C0240016 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Oral hypoglycemic Using 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 Documented
Item
documented diabetes by current ada criteria (98).
boolean
C0011847 (UMLS CUI [1,1])
C1301725 (UMLS CUI [1,2])
Body mass index | Stable body weight
Item
2. 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 (99).
boolean
C1305855 (UMLS CUI [1])
C0517386 (UMLS CUI [2])
Age
Item
3. age between 18-60 years old. individuals older than 60 years of age are excluded due to their increased risk of mortality and peri-operative morbidity.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
4. ability and willingness to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Relocation of home Unlikely
Item
5. no expectation that subject will be moving out of the area of the clinical center during the next 24 months.
boolean
C2699029 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Disease | Coronary Artery Disease | Myocardial Infarction Electrocardiography | Ischemic stroke | Peripheral artery bypass | Percutaneous Transluminal Angioplasty | Amputation Due to Atherosclerosis
Item
1. 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])
C3495795 (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 | Malignant Neoplasms | Exception Diabetes Mellitus
Item
2. 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])
C0006826 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0011849 (UMLS CUI [3,2])
Comorbidity Resulting in Ineligibility Gastric Bypass | Mental disorders Resulting in Ineligibility Gastric Bypass
Item
3. 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
4. pregnancy or planning pregnancy.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Dyslipidemia Severe | Triglycerides measurement | Cholesterol measurement
Item
5. 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
6. uncontrolled hypertension.
boolean
C1868885 (UMLS CUI [1])
Tobacco use
Item
7. smoking.
boolean
C0543414 (UMLS CUI [1])
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