ID

33142

Description

The Effects of High and Low GI Breakfasts on Cognitive Performance in Adults With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01047813

Link

https://clinicaltrials.gov/show/NCT01047813

Keywords

Versions (1)
  1. 11/29/18 11/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 29, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT01047813

English

Eligibility Type 2 Diabetes NCT01047813

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
able to give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
white british or white north american ethnicity and native english speakers
Description

White British | North American White | Native language English

Data type

boolean

Alias
UMLS CUI [1]
C1278523
UMLS CUI [2,1]
C2700615
UMLS CUI [2,2]
C0007457
UMLS CUI [3]
C2135511
not previously received or currently received subcutaneous insulin as part of their diabetes treatment.
Description

Subcutaneous injection of insulin Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0586328
UMLS CUI [1,2]
C0332197
vision sufficiently good to complete the cognitive testing (using glasses and/or lenses).
Description

Vision Sufficient | Testing Cognitive Completion | Eyeglasses Use of | Contact Lenses Use of

Data type

boolean

Alias
UMLS CUI [1,1]
C0042789
UMLS CUI [1,2]
C0205410
UMLS CUI [2,1]
C0039593
UMLS CUI [2,2]
C1516691
UMLS CUI [2,3]
C0205197
UMLS CUI [3,1]
C0015421
UMLS CUI [3,2]
C1524063
UMLS CUI [4,1]
C0009836
UMLS CUI [4,2]
C1524063
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
dementia (as indicated using the mini mental state examination <26)
Description

Dementia Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
current (or recent i.e. in last 6 months) cigarette smoker
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
neurological disorder
Description

Nervous system disorder

Data type

boolean

Alias
UMLS CUI [1]
C0027765
previous stroke
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
medication other than diabetes treatment medication that has a direct effect on the brain and is likely to influence cognitive function.
Description

Pharmaceutical Preparations Effect Brain | Exception Antidiabetics | Pharmaceutical Preparations Influence Cognitive function

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0006104
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0935929
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C4054723
UMLS CUI [3,3]
C0392335
co-existent diabetic complications will not be considered exclusion criteria unless they result in inability to complete the cognitive testing (e.g. insufficient vision).
Description

Complications of Diabetes Mellitus Preventing Testing Cognitive | Vision Insufficient

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0039593
UMLS CUI [1,4]
C1516691
UMLS CUI [2,1]
C0042789
UMLS CUI [2,2]
C0231180
these exclusion criteria have been chosen on the basis that these are factors that can affect cognitive performance. given that the cognitive tests involve learning english words, only participants who have english as their first language can be included because different cognitive processes are used when learning in a non-native language (wong et al., 2004). ethnicity can influence glucose regulation and risk of diabetes. given that part of this research is examining the relationship between glucose regulation and cognition it is important that potential confounds such as ethnicity/genetic propensity to diabetes are controlled for.
Description

Native language English Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2135511
UMLS CUI [1,2]
C0332197
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Similar models

Eligibility Type 2 Diabetes NCT01047813

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
White British | North American White | Native language English
Item
white british or white north american ethnicity and native english speakers
boolean
C1278523 (UMLS CUI [1])
C2700615 (UMLS CUI [2,1])
C0007457 (UMLS CUI [2,2])
C2135511 (UMLS CUI [3])
Subcutaneous injection of insulin Absent
Item
not previously received or currently received subcutaneous insulin as part of their diabetes treatment.
boolean
C0586328 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Vision Sufficient | Testing Cognitive Completion | Eyeglasses Use of | Contact Lenses Use of
Item
vision sufficiently good to complete the cognitive testing (using glasses and/or lenses).
boolean
C0042789 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0039593 (UMLS CUI [2,1])
C1516691 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0015421 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0009836 (UMLS CUI [4,1])
C1524063 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Dementia Mini-mental state examination
Item
dementia (as indicated using the mini mental state examination <26)
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Tobacco use
Item
current (or recent i.e. in last 6 months) cigarette smoker
boolean
C0543414 (UMLS CUI [1])
Nervous system disorder
Item
neurological disorder
boolean
C0027765 (UMLS CUI [1])
Cerebrovascular accident
Item
previous stroke
boolean
C0038454 (UMLS CUI [1])
Pharmaceutical Preparations Effect Brain | Exception Antidiabetics | Pharmaceutical Preparations Influence Cognitive function
Item
medication other than diabetes treatment medication that has a direct effect on the brain and is likely to influence cognitive function.
boolean
C0013227 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0006104 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0935929 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C0392335 (UMLS CUI [3,3])
Complications of Diabetes Mellitus Preventing Testing Cognitive | Vision Insufficient
Item
co-existent diabetic complications will not be considered exclusion criteria unless they result in inability to complete the cognitive testing (e.g. insufficient vision).
boolean
C0342257 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C1516691 (UMLS CUI [1,4])
C0042789 (UMLS CUI [2,1])
C0231180 (UMLS CUI [2,2])
Native language English Absent
Item
these exclusion criteria have been chosen on the basis that these are factors that can affect cognitive performance. given that the cognitive tests involve learning english words, only participants who have english as their first language can be included because different cognitive processes are used when learning in a non-native language (wong et al., 2004). ethnicity can influence glucose regulation and risk of diabetes. given that part of this research is examining the relationship between glucose regulation and cognition it is important that potential confounds such as ethnicity/genetic propensity to diabetes are controlled for.
boolean
C2135511 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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