ID

37397

Description

Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes - Mechanisms of Effective Therapy of Diabetes by Selective Choice of Macronutrients - The Phenotype Study; ODM derived from: https://clinicaltrials.gov/show/NCT02472951

Link

https://clinicaltrials.gov/show/NCT02472951

Keywords

Versions (1)
  1. 7/22/19 7/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 22, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type 2 Diabetes NCT02472951

English

Eligibility Type 2 Diabetes NCT02472951

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men age 18-70 years
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
postmenopausal women age 55-70 years
Description

Gender | Age | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0232970
non-smoker (abstinent at least 6 months)
Description

Non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
hba1c < 74 mmol/mol
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
fasting blood glucose < 11 mmol/l (mean of 3 measurements)
Description

Fasting blood glucose measurement mean

Data type

boolean

Alias
UMLS CUI [1,1]
C0428568
UMLS CUI [1,2]
C0444504
negative (<25 iu/l) plasma glutamate decarboxylase (gad-65) antibodies (igg)
Description

Plasma Glutamate decarboxylase 65 antibody Negative | Measurement of glutamate decarboxylase 65 antibody

Data type

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0806227
UMLS CUI [1,3]
C1513916
UMLS CUI [2]
C1295017
hemoglobin > 7.5 mmol/l (men); > 6.8 mmol/l (women)
Description

Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
normal thrombocytes (140-400 x 109/l)
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
egfr > 45 ml/min per 1.73 m2
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
alkaline phosphatase < 140 iu/l
Description

Alkaline phosphatase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201850
alanine aminotransferase < 70 iu/l
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
normal international normalized ratio (0.9-1.2)
Description

International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0525032
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
critical illness
Description

Critical Illness

Data type

boolean

Alias
UMLS CUI [1]
C0010340
anti-diabetic drugs other than metformin (maximum of 2000 mg / day)
Description

Antidiabetics U/day Maximum | Exception Metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0456683
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
steroid treatment e.g. prednisolone
Description

Steroid therapy | prednisolone

Data type

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2]
C0032950
reported or journalized severe food allergy or intolerance
Description

Food Allergy Severe | Food intolerance Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0016470
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0149696
UMLS CUI [2,2]
C0205082
reported or journalized gut disease e.g. crohn's disease, coeliac disease
Description

Gastrointestinal Disease | Crohn Disease | Celiac Disease

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0007570
reported or journalized alcohol dependence syndrome
Description

Alcoholic Intoxication, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0001973
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes NCT02472951

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
men age 18-70 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender | Age | Postmenopausal state
Item
postmenopausal women age 55-70 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Non-smoker
Item
non-smoker (abstinent at least 6 months)
boolean
C0337672 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c < 74 mmol/mol
boolean
C0474680 (UMLS CUI [1])
Fasting blood glucose measurement mean
Item
fasting blood glucose < 11 mmol/l (mean of 3 measurements)
boolean
C0428568 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Plasma Glutamate decarboxylase 65 antibody Negative | Measurement of glutamate decarboxylase 65 antibody
Item
negative (<25 iu/l) plasma glutamate decarboxylase (gad-65) antibodies (igg)
boolean
C0032105 (UMLS CUI [1,1])
C0806227 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C1295017 (UMLS CUI [2])
Hemoglobin measurement | Gender
Item
hemoglobin > 7.5 mmol/l (men); > 6.8 mmol/l (women)
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Platelet Count measurement
Item
normal thrombocytes (140-400 x 109/l)
boolean
C0032181 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
egfr > 45 ml/min per 1.73 m2
boolean
C3811844 (UMLS CUI [1])
Alkaline phosphatase measurement
Item
alkaline phosphatase < 140 iu/l
boolean
C0201850 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alanine aminotransferase < 70 iu/l
boolean
C0201836 (UMLS CUI [1])
International Normalized Ratio
Item
normal international normalized ratio (0.9-1.2)
boolean
C0525032 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Critical Illness
Item
critical illness
boolean
C0010340 (UMLS CUI [1])
Antidiabetics U/day Maximum | Exception Metformin
Item
anti-diabetic drugs other than metformin (maximum of 2000 mg / day)
boolean
C0935929 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Steroid therapy | prednisolone
Item
steroid treatment e.g. prednisolone
boolean
C0149783 (UMLS CUI [1])
C0032950 (UMLS CUI [2])
Food Allergy Severe | Food intolerance Severe
Item
reported or journalized severe food allergy or intolerance
boolean
C0016470 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0149696 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Gastrointestinal Disease | Crohn Disease | Celiac Disease
Item
reported or journalized gut disease e.g. crohn's disease, coeliac disease
boolean
C0017178 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0007570 (UMLS CUI [3])
Alcoholic Intoxication, Chronic
Item
reported or journalized alcohol dependence syndrome
boolean
C0001973 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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