ID

38773

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01705210

Keywords

versioni (1)
  1. 03/11/19 03/11/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

3 novembre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Diabetes Mellitus, Type 2 NCT01705210

Inglese

Eligibility Diabetes Mellitus, Type 2 NCT01705210

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects aged 40-75 years
Descrizione

Age

Tipo di dati

boolean

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

Enrollment Clinical Trial Specified

Tipo di dati

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
Descrizione

Written consent Research Additional

Tipo di dati

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)
Descrizione

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

Tipo di dati

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:
Descrizione

Individuals Non-Insulin-Dependent Diabetes Mellitus

Tipo di dati

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
Descrizione

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

Tipo di dati

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:
Descrizione

Metabolic Syndrome

Tipo di dati

boolean

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

Criteria Quantity Fulfill

Tipo di dati

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)
Descrizione

Waist Circumference | Gender

Tipo di dati

boolean

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

Triglycerides measurement

Tipo di dati

boolean

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

Serum HDL cholesterol measurement | Gender

Tipo di dati

boolean

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

Blood pressure determination

Tipo di dati

boolean

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

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

Tipo di dati

boolean

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

Control Group

Tipo di dati

boolean

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

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

Tipo di dati

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
Descrizione

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).
Descrizione

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

Tipo di dati

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.
Descrizione

Comorbidity Psychiatric | MRI Tests Functional Unable

Tipo di dati

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
Descrizione

Cognitive Assessment Incomplete

Tipo di dati

boolean

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

Diabetes Mellitus, Insulin-Dependent

Tipo di dati

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).
Descrizione

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

Tipo di dati

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
Descrizione

Timepoint Visit Clinical Trial Specified

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0008952
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205369
Ritorna all'inizio della pagina

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01705210

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial