ID

32943

Beschrijving

Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion; ODM derived from: https://clinicaltrials.gov/show/NCT01046994

Link

https://clinicaltrials.gov/show/NCT01046994

Trefwoorden

Versies (1)
  1. 21-11-18 21-11-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

21 november 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01046994

Engels

Eligibility Type 2 Diabetes Mellitus NCT01046994

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 35-70 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
diabetes duration: >5 years
Beschrijving

Diabetes Mellitus Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0449238
documented poor glycemic control (hba1c =>8% despite medical treatment according to gcp)
Beschrijving

Poor glycemic control | Hemoglobin A1c measurement | Treatment Consistent with Good Clinical Practice

Datatype

boolean

Alias
UMLS CUI [1]
C0342299
UMLS CUI [2]
C0474680
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C2986419
presence of comorbidities or complications (e.g. dyslipidemia, arterial hypertension, neuropathy, retinopathy, cvd, previous stroke or tia, lower limb amputation)
Beschrijving

Comorbidity | Complications | Dyslipidemias | Hypertensive disease | Neuropathy | Retinal Diseases | Cardiovascular Diseases | Cerebrovascular accident | Transient Ischemic Attack | Amputation of lower limb

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0009566
UMLS CUI [3]
C0242339
UMLS CUI [4]
C0020538
UMLS CUI [5]
C0442874
UMLS CUI [6]
C0035309
UMLS CUI [7]
C0007222
UMLS CUI [8]
C0038454
UMLS CUI [9]
C0007787
UMLS CUI [10]
C0337308
availability to comply with the entire follow-up
Beschrijving

Compliance behavior Follow-up

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
general contraindications to bpd (applies also to medical controls)
Beschrijving

Medical contraindication Biliopancreatic Diversion

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0005435
presence of anti-islet or anti-gad antibodies or plasma c-peptide concentration <0.5 mcg/l
Beschrijving

Anti-islet cell antibody | Anti-GAD antibody | Plasma insulin C-peptide level

Datatype

boolean

Alias
UMLS CUI [1]
C0063900
UMLS CUI [2]
C1167897
UMLS CUI [3]
C1303121
blindness
Beschrijving

Blindness

Datatype

boolean

Alias
UMLS CUI [1]
C0456909
severe concomitant medical conditions (e.g. liver cirrhosis, renal failure, collagen diseases, severe endocrinopathies)
Beschrijving

Comorbidity Severe | Liver Cirrhosis | Kidney Failure | Collagen Diseases | Endocrine System Diseases Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0035078
UMLS CUI [4]
C0009326
UMLS CUI [5,1]
C0014130
UMLS CUI [5,2]
C0205082
heart failure
Beschrijving

Heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
recent history (less than 12 months) of myocardial infarction, stroke or tia
Beschrijving

Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

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

Angina, Unstable

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
pregnancy
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
previous or concomitant malignancy
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
severe active inflammatory, neurologic, or cardiovascular conditions
Beschrijving

Inflammatory disorder Severe | Nervous system disorder Severe | Cardiovascular Diseases Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C1290884
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0007222
UMLS CUI [3,2]
C0205082
geographic inaccessibility
Beschrijving

Unavailability Geographic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686905
UMLS CUI [1,2]
C1517526
any condition which, in the opinion of the principal investigator, may make risky the participation in the study or bias the results
Beschrijving

Condition Study Subject Participation Status At risk | Condition Biases Research results

Datatype

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]
C0242568
UMLS CUI [2,3]
C0683954
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT01046994

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: 35-70 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus Duration
Item
diabetes duration: >5 years
boolean
C0011849 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Poor glycemic control | Hemoglobin A1c measurement | Treatment Consistent with Good Clinical Practice
Item
documented poor glycemic control (hba1c =>8% despite medical treatment according to gcp)
boolean
C0342299 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C2986419 (UMLS CUI [3,3])
Comorbidity | Complications | Dyslipidemias | Hypertensive disease | Neuropathy | Retinal Diseases | Cardiovascular Diseases | Cerebrovascular accident | Transient Ischemic Attack | Amputation of lower limb
Item
presence of comorbidities or complications (e.g. dyslipidemia, arterial hypertension, neuropathy, retinopathy, cvd, previous stroke or tia, lower limb amputation)
boolean
C0009488 (UMLS CUI [1])
C0009566 (UMLS CUI [2])
C0242339 (UMLS CUI [3])
C0020538 (UMLS CUI [4])
C0442874 (UMLS CUI [5])
C0035309 (UMLS CUI [6])
C0007222 (UMLS CUI [7])
C0038454 (UMLS CUI [8])
C0007787 (UMLS CUI [9])
C0337308 (UMLS CUI [10])
Compliance behavior Follow-up
Item
availability to comply with the entire follow-up
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Biliopancreatic Diversion
Item
general contraindications to bpd (applies also to medical controls)
boolean
C1301624 (UMLS CUI [1,1])
C0005435 (UMLS CUI [1,2])
Anti-islet cell antibody | Anti-GAD antibody | Plasma insulin C-peptide level
Item
presence of anti-islet or anti-gad antibodies or plasma c-peptide concentration <0.5 mcg/l
boolean
C0063900 (UMLS CUI [1])
C1167897 (UMLS CUI [2])
C1303121 (UMLS CUI [3])
Blindness
Item
blindness
boolean
C0456909 (UMLS CUI [1])
Comorbidity Severe | Liver Cirrhosis | Kidney Failure | Collagen Diseases | Endocrine System Diseases Severe
Item
severe concomitant medical conditions (e.g. liver cirrhosis, renal failure, collagen diseases, severe endocrinopathies)
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
C0009326 (UMLS CUI [4])
C0014130 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Heart failure
Item
heart failure
boolean
C0018801 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
recent history (less than 12 months) of myocardial infarction, stroke or tia
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Angina, Unstable
Item
unstable angina
boolean
C0002965 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Malignant Neoplasms
Item
previous or concomitant malignancy
boolean
C0006826 (UMLS CUI [1])
Inflammatory disorder Severe | Nervous system disorder Severe | Cardiovascular Diseases Severe
Item
severe active inflammatory, neurologic, or cardiovascular conditions
boolean
C1290884 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Unavailability Geographic
Item
geographic inaccessibility
boolean
C0686905 (UMLS CUI [1,1])
C1517526 (UMLS CUI [1,2])
Condition Study Subject Participation Status At risk | Condition Biases Research results
Item
any condition which, in the opinion of the principal 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])
C0242568 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
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