ID

28990

Description

Multicentric Prospective Randomized Trial on Surgery Versus Standard Medical Care in Type 2 Diabetic Patients BMI 30-35; ODM derived from: https://clinicaltrials.gov/show/NCT01041768

Link

https://clinicaltrials.gov/show/NCT01041768

Keywords

Versions (1)
  1. 2/19/18 2/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 19, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT01041768

English

Eligibility Diabetes Mellitus NCT01041768

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
bmi ≥30 and ≤34.9 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
age between 35 and 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
duration of diabetes ≥ 5 years
Description

Diabetes Mellitus Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0449238
poor glycemic control (i.e., hba1c ≥ 8%) in spite a medical antidiabetic therapy in accordance with good clinical practice (gcp)
Description

Poor glycemic control | Glucohemoglobin measurement | Antidiabetics

Data type

boolean

Alias
UMLS CUI [1]
C0342299
UMLS CUI [2]
C0202054
UMLS CUI [3]
C0935929
presence of significant co-morbidities or complications (such as dyslipidemia, arterial hypertension, impaired renal function, neuropathy, retinopathy, cvd)
Description

Comorbidity | Complications | Dyslipidemia | Hypertensive disease | Renal Insufficiency | Neuropathy | Retinal Diseases | Cardiovascular Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0009566
UMLS CUI [3]
C0242339
UMLS CUI [4]
C0020538
UMLS CUI [5]
C1565489
UMLS CUI [6]
C0442874
UMLS CUI [7]
C0035309
UMLS CUI [8]
C0007222
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
specific contraindication to obesity surgery or gbp or bpd, including any gastric alteration specifically contraindicating gbp
Description

Medical contraindication Obesity surgery | Medical contraindication Roux-en-Y Gastric Bypass | Medical contraindication Biliopancreatic Diversion | Medical contraindication Gastrointestinal alteration: Gastric bypass

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1167841
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0585179
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0005435
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0548816
hba1c < 8%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
positive autoantibodies anti-pancreas islet
Description

Autoantibodies to islet cells Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C2097865
UMLS CUI [1,2]
C1514241
serum c-peptide < 0.5 ng/ml
Description

C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202100
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
medical conditions requiring acute hospitalisation
Description

Medical condition Hospitalization Required

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1708385
severe diabetes complications or associated medical conditions (such as blindness, end-stage renal failure, liver cirrhosis, malignancy, chronic congestive heart failure
Description

Complications of Diabetes Mellitus Severe | Medical condition Associated with Complications of Diabetes Mellitus | Blind Vision | Kidney Failure, Chronic | Liver Cirrhosis | Malignant Neoplasms | Chronic congestive heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0342257
UMLS CUI [3]
C0456909
UMLS CUI [4]
C0022661
UMLS CUI [5]
C0023890
UMLS CUI [6]
C0006826
UMLS CUI [7]
C0264722
recent (within preceding 12 months) myocardial infarction, stroke or tia
Description

Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
unstable angina pectoris
Description

Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0002965
psychological conditions which may hamper patient's cooperation
Description

Condition Psychological Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205486
UMLS CUI [1,3]
C1321605
UMLS CUI [1,4]
C0439801
geographic inaccessibility
Description

Patient unavailable Due to Geographic Factors

Data type

boolean

Alias
UMLS CUI [1,1]
C1301818
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0017444
any condition which, in the judgement of the investigator, may make risky the participation in the study or bias the results
Description

Condition Study Subject Participation Status At risk | Condition Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
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Similar models

Eligibility Diabetes Mellitus NCT01041768

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
bmi ≥30 and ≤34.9 kg/m2
boolean
C1305855 (UMLS CUI [1])
Age
Item
age between 35 and 70 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus Duration
Item
duration of diabetes ≥ 5 years
boolean
C0011849 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Poor glycemic control | Glucohemoglobin measurement | Antidiabetics
Item
poor glycemic control (i.e., hba1c ≥ 8%) in spite a medical antidiabetic therapy in accordance with good clinical practice (gcp)
boolean
C0342299 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
C0935929 (UMLS CUI [3])
Comorbidity | Complications | Dyslipidemia | Hypertensive disease | Renal Insufficiency | Neuropathy | Retinal Diseases | Cardiovascular Diseases
Item
presence of significant co-morbidities or complications (such as dyslipidemia, arterial hypertension, impaired renal function, neuropathy, retinopathy, cvd)
boolean
C0009488 (UMLS CUI [1])
C0009566 (UMLS CUI [2])
C0242339 (UMLS CUI [3])
C0020538 (UMLS CUI [4])
C1565489 (UMLS CUI [5])
C0442874 (UMLS CUI [6])
C0035309 (UMLS CUI [7])
C0007222 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Obesity surgery | Medical contraindication Roux-en-Y Gastric Bypass | Medical contraindication Biliopancreatic Diversion | Medical contraindication Gastrointestinal alteration: Gastric bypass
Item
specific contraindication to obesity surgery or gbp or bpd, including any gastric alteration specifically contraindicating gbp
boolean
C1301624 (UMLS CUI [1,1])
C1167841 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0585179 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0005435 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0548816 (UMLS CUI [4,2])
Glucohemoglobin measurement
Item
hba1c < 8%
boolean
C0202054 (UMLS CUI [1])
Autoantibodies to islet cells Positive
Item
positive autoantibodies anti-pancreas islet
boolean
C2097865 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C-peptide measurement
Item
serum c-peptide < 0.5 ng/ml
boolean
C0202100 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Medical condition Hospitalization Required
Item
medical conditions requiring acute hospitalisation
boolean
C3843040 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
Complications of Diabetes Mellitus Severe | Medical condition Associated with Complications of Diabetes Mellitus | Blind Vision | Kidney Failure, Chronic | Liver Cirrhosis | Malignant Neoplasms | Chronic congestive heart failure
Item
severe diabetes complications or associated medical conditions (such as blindness, end-stage renal failure, liver cirrhosis, malignancy, chronic congestive heart failure
boolean
C0342257 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0342257 (UMLS CUI [2,3])
C0456909 (UMLS CUI [3])
C0022661 (UMLS CUI [4])
C0023890 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
C0264722 (UMLS CUI [7])
Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
recent (within preceding 12 months) myocardial infarction, stroke or tia
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Angina, Unstable
Item
unstable angina pectoris
boolean
C0002965 (UMLS CUI [1])
Condition Psychological Compliance behavior Limited
Item
psychological conditions which may hamper patient's cooperation
boolean
C0348080 (UMLS CUI [1,1])
C0205486 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
Patient unavailable Due to Geographic Factors
Item
geographic inaccessibility
boolean
C1301818 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0017444 (UMLS CUI [1,3])
Condition Study Subject Participation Status At risk | Condition Interferes with Research results
Item
any condition which, in the judgement of the investigator, may make risky the participation in the study or bias the results
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
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