ID

31768

Description

Study of Liraglutide Versus Insulin on Liver Fat Fraction in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01399645

Link

https://clinicaltrials.gov/show/NCT01399645

Keywords

Versions (2)
  1. 9/26/18 9/26/18 -
  2. 9/27/18 9/27/18 - Sarah Riepenhausen
Copyright Holder

Centre hospitalier de l'Université de Montréal (CHUM)

Uploaded on

September 27, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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 Nonalcoholic Fatty Liver Disease NCT01399645

English

Eligibility Nonalcoholic Fatty Liver Disease NCT01399645

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
are 18 y.o. or older at screening (first visit),
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
are ambulatory,
Description

Ambulatory

Data type

boolean

Alias
UMLS CUI [1]
C0439841
are known for type 2 diabetes with criteria of failure of metformin monotherapy, metformin-sulfonylurea, metformin-repaglinide combined therapy defined as hba1c ≥6.5,
Description

Diabetes typ 2, failure therapy with metformin, metformin-sulfonylurea, metformin-repaglinide; HBA1c

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C1272705
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C1272705
UMLS CUI [3,2]
C0025598
UMLS CUI [3,3]
C0038766
UMLS CUI [3,4]
C0205195
UMLS CUI [4,1]
C1272705
UMLS CUI [4,2]
C0025598
UMLS CUI [4,3]
C0246689
UMLS CUI [4,4]
C0205195
UMLS CUI [5]
C0202054
abdominal girth > 94 cm for men and > 80 cm for women,
Description

Abdominal girth

Data type

boolean

Alias
UMLS CUI [1]
C0232501
understand french or english instruction,
Description

Language comprehension in french/english

Data type

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376246
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
able to comprehend and willingness to provide voluntary consent.
Description

Comprehension and Willingness to consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have any contra-indications for mri (such as metallic implants, pacemaker or claustrophobia),
Description

Contraindication for MRI (metallic implants, pacemaker, claustrophobia)

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0522473
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C2986473
UMLS CUI [3]
C0848753
UMLS CUI [4]
C0008909
have type 1 diabetes or have had episodes of ketoacidosis,
Description

Diabetes typ 1, episodes of ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0220982
have any major debilitating disease including malignant disorders
Description

Severe disease, malignant disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0006826
have had, within the last 6 months, evidence of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty (ptca), congestive heart failure (new york heart association class iii-iv), or severe ischemic disease,
Description

significant heart disease or stroke (myocardial infarction, unstable angina, coronary bypass and/or ptca, congestive heart failure (NYHA iii-iv), severe ischemic disease)

Data type

boolean

Alias
UMLS CUI [1,1]
C0750502
UMLS CUI [1,2]
C0018799
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0038454
UMLS CUI [2,2]
C0332185
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0010055
UMLS CUI [5,2]
C2936173
UMLS CUI [6,1]
C0018802
UMLS CUI [6,2]
C1275491
UMLS CUI [7,1]
C0205082
UMLS CUI [7,2]
C0151744
patients having received insulin within 3 months prior to screening,
Description

Received insulin 3 months prior to screening

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332185
have a serum creatine above >150 mmol/l or estimated gfr < 30 ml/min,
Description

Serum creatine, estimated GFR

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C4524116
women seeking pregnancy,
Description

Pregnancy planned

Data type

boolean

Alias
UMLS CUI [1]
C0032992
have a history of chronic liver disease other than nafld, including hbv and hcv infection, hemochromatosis, wilson's disease, alpha-1-antitrypsin deficiency, autoimmune hepatitis,
Description

Other chronic liver diseases than NAFLD (HBV, HCV, hemochromatosis, wilson's disease, alpha-1-antitrypsin deficiency, autoimmune hepatitis)

Data type

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0400966
UMLS CUI [2]
C2242656
UMLS CUI [3]
C1698259
UMLS CUI [4]
C0018995
UMLS CUI [5]
C0019202
UMLS CUI [6]
C0221757
UMLS CUI [7]
C0241910
current or previous use of oral or injectable corticosteroids,
Description

Current/previous oral/injectable corticosteroids use

Data type

boolean

Alias
UMLS CUI [1,1]
C0442027
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0521116
UMLS CUI [2,1]
C0442027
UMLS CUI [2,2]
C0001617
UMLS CUI [2,3]
C0205156
UMLS CUI [3,1]
C0086466
UMLS CUI [3,2]
C0001617
UMLS CUI [3,3]
C0521116
UMLS CUI [4,1]
C0086466
UMLS CUI [4,2]
C0001617
UMLS CUI [4,3]
C0205156
have excessive alcohol intake, defined as a daily limit of 30 g (3 drinks) for men and 20 g (2 drinks) for women.
Description

Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0560578
Back to the top of the page

Similar models

Eligibility Nonalcoholic Fatty Liver Disease NCT01399645

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
are 18 y.o. or older at screening (first visit),
boolean
C0001779 (UMLS CUI [1])
Ambulatory
Item
are ambulatory,
boolean
C0439841 (UMLS CUI [1])
Diabetes typ 2, failure therapy with metformin, metformin-sulfonylurea, metformin-repaglinide; HBA1c
Item
are known for type 2 diabetes with criteria of failure of metformin monotherapy, metformin-sulfonylurea, metformin-repaglinide combined therapy defined as hba1c ≥6.5,
boolean
C0011860 (UMLS CUI [1])
C1272705 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1272705 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
C0038766 (UMLS CUI [3,3])
C0205195 (UMLS CUI [3,4])
C1272705 (UMLS CUI [4,1])
C0025598 (UMLS CUI [4,2])
C0246689 (UMLS CUI [4,3])
C0205195 (UMLS CUI [4,4])
C0202054 (UMLS CUI [5])
Abdominal girth
Item
abdominal girth > 94 cm for men and > 80 cm for women,
boolean
C0232501 (UMLS CUI [1])
Language comprehension in french/english
Item
understand french or english instruction,
boolean
C0233733 (UMLS CUI [1,1])
C0376246 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Comprehension and Willingness to consent
Item
able to comprehend and willingness to provide voluntary consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Contraindication for MRI (metallic implants, pacemaker, claustrophobia)
Item
have any contra-indications for mri (such as metallic implants, pacemaker or claustrophobia),
boolean
C0024485 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0021102 (UMLS CUI [2,1])
C2986473 (UMLS CUI [2,2])
C0848753 (UMLS CUI [3])
C0008909 (UMLS CUI [4])
Diabetes typ 1, episodes of ketoacidosis
Item
have type 1 diabetes or have had episodes of ketoacidosis,
boolean
C0011854 (UMLS CUI [1])
C0332189 (UMLS CUI [2,1])
C0220982 (UMLS CUI [2,2])
Severe disease, malignant disorder
Item
have any major debilitating disease including malignant disorders
boolean
C0012634 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
significant heart disease or stroke (myocardial infarction, unstable angina, coronary bypass and/or ptca, congestive heart failure (NYHA iii-iv), severe ischemic disease)
Item
have had, within the last 6 months, evidence of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty (ptca), congestive heart failure (new york heart association class iii-iv), or severe ischemic disease,
boolean
C0750502 (UMLS CUI [1,1])
C0018799 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0038454 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0010055 (UMLS CUI [5,1])
C2936173 (UMLS CUI [5,2])
C0018802 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
C0205082 (UMLS CUI [7,1])
C0151744 (UMLS CUI [7,2])
Received insulin 3 months prior to screening
Item
patients having received insulin within 3 months prior to screening,
boolean
C0021641 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Serum creatine, estimated GFR
Item
have a serum creatine above >150 mmol/l or estimated gfr < 30 ml/min,
boolean
C0201976 (UMLS CUI [1])
C4524116 (UMLS CUI [2])
Pregnancy planned
Item
women seeking pregnancy,
boolean
C0032992 (UMLS CUI [1])
Other chronic liver diseases than NAFLD (HBV, HCV, hemochromatosis, wilson's disease, alpha-1-antitrypsin deficiency, autoimmune hepatitis)
Item
have a history of chronic liver disease other than nafld, including hbv and hcv infection, hemochromatosis, wilson's disease, alpha-1-antitrypsin deficiency, autoimmune hepatitis,
boolean
C0341439 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0400966 (UMLS CUI [1,3])
C2242656 (UMLS CUI [2])
C1698259 (UMLS CUI [3])
C0018995 (UMLS CUI [4])
C0019202 (UMLS CUI [5])
C0221757 (UMLS CUI [6])
C0241910 (UMLS CUI [7])
Current/previous oral/injectable corticosteroids use
Item
current or previous use of oral or injectable corticosteroids,
boolean
C0442027 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C0442027 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0086466 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C0521116 (UMLS CUI [3,3])
C0086466 (UMLS CUI [4,1])
C0001617 (UMLS CUI [4,2])
C0205156 (UMLS CUI [4,3])
Alcohol abuse
Item
have excessive alcohol intake, defined as a daily limit of 30 g (3 drinks) for men and 20 g (2 drinks) for women.
boolean
C0085762 (UMLS CUI [1,1])
C0560578 (UMLS CUI [1,2])
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