ID

38773

Description

Functional MRI Biomarkers of Cognitive Decrements in Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01705210

Link

https://clinicaltrials.gov/show/NCT01705210

Keywords

Versions (1)
  1. 11/3/19 11/3/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01705210

English

Eligibility Diabetes Mellitus, Type 2 NCT01705210

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects aged 40-75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects enrolled in the existing 'maastricht study' (m-study)
Description

Enrollment Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
subjects gave written consent to be approached for additional research
Description

Written consent Research Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0811746
UMLS CUI [1,2]
C0035168
UMLS CUI [1,3]
C1524062
subjects belongs to the 20% of the worst and 20% of the best performing (as based on neuropsychological cognitive testing (stroop color-word test, 15 word learning test, and delayed recall and recognition 15 word learning test)
Description

Performance Percentage | Cognitive functions Testing | Stroop Test | Modified word learning test

Data type

boolean

Alias
UMLS CUI [1,1]
C1882330
UMLS CUI [1,2]
C0439165
UMLS CUI [2,1]
C0392335
UMLS CUI [2,2]
C0039593
UMLS CUI [3]
C2718024
UMLS CUI [4]
C0451314
individuals diabetes type 2:
Description

Individuals Non-Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0011860
fasting blood glucose ≥ 7.0 mmol/l, after an oral glucose tolerance test (ogtt)blood glucose ≥ 11.1 mmol/l or used oral glucose-lowering medication or insulin
Description

Fasting blood glucose measurement | Status post Blood glucose measurement Oral Glucose Tolerance Test | Oral hypoglycemic | Insulin use

Data type

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0392201
UMLS CUI [2,3]
C0029161
UMLS CUI [3]
C0359086
UMLS CUI [4]
C0240016
metabolic syndrome:
Description

Metabolic Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0524620
participants should meet three out of 5 of the following criteria [8]:
Description

Criteria Quantity Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
1. waist circumference > 88 cm (women), > 102 cm (men)
Description

Waist Circumference | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0455829
UMLS CUI [2]
C0079399
2. triglycerides ≥ 1.7 mmol/l
Description

Triglycerides measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202236
3. hdl cholesterol < 1.3 mmol/l (women), < 1.0 mmol/l (men)
Description

Serum HDL cholesterol measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0428472
UMLS CUI [2]
C0079399
4. blood pressure ≥ 130/85 mmhg (or medication)
Description

Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C0005824
5. fasting blood glucose ≥ 6.1 mmol/l, after an ogtt blood glucose ≥ 7.8 mmol/l
Description

Fasting blood glucose measurement | Status post Blood glucose measurement Oral Glucose Tolerance Test

Data type

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0392201
UMLS CUI [2,3]
C0029161
control participants:
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
those who fulfilled no more than 1 criterium of the metabolic syndrome, no dm2.
Description

Criteria Quantity Fulfill | Metabolic Syndrome | Non-Insulin-Dependent Diabetes Mellitus Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
UMLS CUI [2]
C0524620
UMLS CUI [3,1]
C0011860
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contra-indications for mri examination (e.g. pacemaker; neurostimulator; medication pump; cochlear or hearing implant; tattoos or other items that cannot be removed and include metal parts (for instance from operations in the past); metal splinter in the eye; pregnancy and claustrophobia; brain vessel clamps; denture, which contains magnets).
Description

Medical contraindication MRI | Artificial cardiac pacemaker | Neurostimulator | Pharmaceutical Preparation pump | Cochlear Implants | Hearing Implants | Tattoos | Foreign Bodies Metallic | Splinter Metallic Eye | Pregnancy | Claustrophobia | Vascular clamp Brain | Denture Containing Magnet

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0582124
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0182537
UMLS CUI [5]
C0009199
UMLS CUI [6,1]
C0018767
UMLS CUI [6,2]
C0021102
UMLS CUI [7]
C1366940
UMLS CUI [8,1]
C0016542
UMLS CUI [8,2]
C2986473
UMLS CUI [9,1]
C1960195
UMLS CUI [9,2]
C2986473
UMLS CUI [9,3]
C0015392
UMLS CUI [10]
C0032961
UMLS CUI [11]
C0008909
UMLS CUI [12,1]
C0179955
UMLS CUI [12,2]
C0006104
UMLS CUI [13,1]
C0011394
UMLS CUI [13,2]
C0332256
UMLS CUI [13,3]
C0024483
psychiatric co-morbidity and inability to perform the functional mri tests.
Description

Comorbidity Psychiatric | MRI Tests Functional Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205487
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C0022885
UMLS CUI [2,3]
C0205245
UMLS CUI [2,4]
C1299582
incomplete cognitive assessment data
Description

Cognitive Assessment Incomplete

Data type

boolean

Alias
UMLS CUI [1,1]
C0870300
UMLS CUI [1,2]
C0205257
diabetes mellitus type 1 (dm1)
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
subjects who are not belonging to the 20% of the worst and 20% of the best performing individuals (as based on neuropsychological cognitive testing (stroop color-word test, 15 word learning test, and delayed recall and recognition 15 word learning test).
Description

Performance Percentage | Cognitive functions Testing | Stroop Test | Modified word learning test

Data type

boolean

Alias
UMLS CUI [1,1]
C1882330
UMLS CUI [1,2]
C0439165
UMLS CUI [2,1]
C0392335
UMLS CUI [2,2]
C0039593
UMLS CUI [3]
C2718024
UMLS CUI [4]
C0451314
last visit of the subjects to the m-study should be less than one year
Description

Timepoint Visit Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0008952
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205369
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01705210

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subjects aged 40-75 years
boolean
C0001779 (UMLS CUI [1])
Enrollment Clinical Trial Specified
Item
subjects enrolled in the existing 'maastricht study' (m-study)
boolean
C1516879 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Written consent Research Additional
Item
subjects gave written consent to be approached for additional research
boolean
C0811746 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
Performance Percentage | Cognitive functions Testing | Stroop Test | Modified word learning test
Item
subjects belongs to the 20% of the worst and 20% of the best performing (as based on neuropsychological cognitive testing (stroop color-word test, 15 word learning test, and delayed recall and recognition 15 word learning test)
boolean
C1882330 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0392335 (UMLS CUI [2,1])
C0039593 (UMLS CUI [2,2])
C2718024 (UMLS CUI [3])
C0451314 (UMLS CUI [4])
Individuals Non-Insulin-Dependent Diabetes Mellitus
Item
individuals diabetes type 2:
boolean
C0027361 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Fasting blood glucose measurement | Status post Blood glucose measurement Oral Glucose Tolerance Test | Oral hypoglycemic | Insulin use
Item
fasting blood glucose ≥ 7.0 mmol/l, after an oral glucose tolerance test (ogtt)blood glucose ≥ 11.1 mmol/l or used oral glucose-lowering medication or insulin
boolean
C0428568 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0392201 (UMLS CUI [2,2])
C0029161 (UMLS CUI [2,3])
C0359086 (UMLS CUI [3])
C0240016 (UMLS CUI [4])
Metabolic Syndrome
Item
metabolic syndrome:
boolean
C0524620 (UMLS CUI [1])
Criteria Quantity Fulfill
Item
participants should meet three out of 5 of the following criteria [8]:
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Waist Circumference | Gender
Item
1. waist circumference > 88 cm (women), > 102 cm (men)
boolean
C0455829 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Triglycerides measurement
Item
2. triglycerides ≥ 1.7 mmol/l
boolean
C0202236 (UMLS CUI [1])
Serum HDL cholesterol measurement | Gender
Item
3. hdl cholesterol < 1.3 mmol/l (women), < 1.0 mmol/l (men)
boolean
C0428472 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Blood pressure determination
Item
4. blood pressure ≥ 130/85 mmhg (or medication)
boolean
C0005824 (UMLS CUI [1])
Fasting blood glucose measurement | Status post Blood glucose measurement Oral Glucose Tolerance Test
Item
5. fasting blood glucose ≥ 6.1 mmol/l, after an ogtt blood glucose ≥ 7.8 mmol/l
boolean
C0428568 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0392201 (UMLS CUI [2,2])
C0029161 (UMLS CUI [2,3])
Control Group
Item
control participants:
boolean
C0009932 (UMLS CUI [1])
Criteria Quantity Fulfill | Metabolic Syndrome | Non-Insulin-Dependent Diabetes Mellitus Absent
Item
those who fulfilled no more than 1 criterium of the metabolic syndrome, no dm2.
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0524620 (UMLS CUI [2])
C0011860 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication MRI | Artificial cardiac pacemaker | Neurostimulator | Pharmaceutical Preparation pump | Cochlear Implants | Hearing Implants | Tattoos | Foreign Bodies Metallic | Splinter Metallic Eye | Pregnancy | Claustrophobia | Vascular clamp Brain | Denture Containing Magnet
Item
contra-indications for mri examination (e.g. pacemaker; neurostimulator; medication pump; cochlear or hearing implant; tattoos or other items that cannot be removed and include metal parts (for instance from operations in the past); metal splinter in the eye; pregnancy and claustrophobia; brain vessel clamps; denture, which contains magnets).
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0582124 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0182537 (UMLS CUI [4,2])
C0009199 (UMLS CUI [5])
C0018767 (UMLS CUI [6,1])
C0021102 (UMLS CUI [6,2])
C1366940 (UMLS CUI [7])
C0016542 (UMLS CUI [8,1])
C2986473 (UMLS CUI [8,2])
C1960195 (UMLS CUI [9,1])
C2986473 (UMLS CUI [9,2])
C0015392 (UMLS CUI [9,3])
C0032961 (UMLS CUI [10])
C0008909 (UMLS CUI [11])
C0179955 (UMLS CUI [12,1])
C0006104 (UMLS CUI [12,2])
C0011394 (UMLS CUI [13,1])
C0332256 (UMLS CUI [13,2])
C0024483 (UMLS CUI [13,3])
Comorbidity Psychiatric | MRI Tests Functional Unable
Item
psychiatric co-morbidity and inability to perform the functional mri tests.
boolean
C0009488 (UMLS CUI [1,1])
C0205487 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C0205245 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
Cognitive Assessment Incomplete
Item
incomplete cognitive assessment data
boolean
C0870300 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
diabetes mellitus type 1 (dm1)
boolean
C0011854 (UMLS CUI [1])
Performance Percentage | Cognitive functions Testing | Stroop Test | Modified word learning test
Item
subjects who are not belonging to the 20% of the worst and 20% of the best performing individuals (as based on neuropsychological cognitive testing (stroop color-word test, 15 word learning test, and delayed recall and recognition 15 word learning test).
boolean
C1882330 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0392335 (UMLS CUI [2,1])
C0039593 (UMLS CUI [2,2])
C2718024 (UMLS CUI [3])
C0451314 (UMLS CUI [4])
Timepoint Visit Clinical Trial Specified
Item
last visit of the subjects to the m-study should be less than one year
boolean
C2348792 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
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