ID

37377

Description

Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02014740

Link

https://clinicaltrials.gov/show/NCT02014740

Keywords

Versions (1)
  1. 7/20/19 7/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 20, 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 NCT02014740

English

Eligibility Type 2 Diabetes NCT02014740

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes, as defined by ada criteria
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hba1c < 8% measured at least 1 month prior to this study
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
bmi ≥27 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
pre-treatment with metformin
Description

Metformin pre treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C2709094
age > 18 and < 65 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
• known contra-indications to liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of men, in accordance with risks and safety information included in the latest updated prescribing information for victoza®
Description

Medical contraindication Liraglutide | Pancreatitis | Medullary carcinoma of thyroid | Multiple Endocrine Neoplasia | Family history of multiple endocrine neoplasia | Pharmaceutical Product Information Victoza

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1456408
UMLS CUI [2]
C0030305
UMLS CUI [3]
C0238462
UMLS CUI [4]
C0027662
UMLS CUI [5]
C4039247
UMLS CUI [6,1]
C1709517
UMLS CUI [6,2]
C2732208
type 1 diabetes, as defined by american diabetes association (ada) criteria
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
insulin dependent or treated type 2 diabetes
Description

Insulin Dependence | Non-Insulin-Dependent Diabetes Mellitus Treated

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0439857
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C1522326
current use of other injectable incretins
Description

Incretins injectable

Data type

boolean

Alias
UMLS CUI [1,1]
C1562292
UMLS CUI [1,2]
C0086466
history of diabetes ketoacidosis
Description

Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0011880
advanced chronic kidney disease, as defined by glomerular filtration rate (gfr) < 30 ml/min/1.73m2
Description

Chronic Kidney Disease Advanced | Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0017654
clinical signs or symptoms of new york heart association (nyha) class iii-iv heart failure
Description

Sign or Symptom Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C1275491
clinical or laboratory evidences of chronic active liver diseases
Description

Chronic liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0341439
acute or chronic infective diseases
Description

Communicable Diseases | Chronic infectious disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
cancer or chemotherapy
Description

Malignant Neoplasms | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0392920
current use of systemic corticosteroids or in the 3 months prior this study
Description

CORTICOSTEROIDS FOR SYSTEMIC USE

Data type

boolean

Alias
UMLS CUI [1]
C3653708
known or suspected allergy to liraglutide, excipients, or related products
Description

Hypersensitivity Liraglutide | Hypersensitivity Suspected Liraglutide | Hypersensitivity Liraglutide Excipient | Hypersensitivity Suspected Liraglutide Excipient | Hypersensitivity Pharmaceutical Products Related | Hypersensitivity Suspected Pharmaceutical Products Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1456408
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C1456408
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1456408
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C1456408
UMLS CUI [4,4]
C0015237
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0013227
UMLS CUI [5,3]
C0439849
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C0013227
UMLS CUI [6,4]
C0439849
pregnant, breast-feeding or the intention of becoming pregnant
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
females of childbearing potential who are not using adequate contraceptive methods
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes NCT02014740

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes, as defined by ada criteria
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c < 8% measured at least 1 month prior to this study
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi ≥27 kg/m2
boolean
C1305855 (UMLS CUI [1])
Metformin pre treatment
Item
pre-treatment with metformin
boolean
C0025598 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
Age
Item
age > 18 and < 65 years old
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Liraglutide | Pancreatitis | Medullary carcinoma of thyroid | Multiple Endocrine Neoplasia | Family history of multiple endocrine neoplasia | Pharmaceutical Product Information Victoza
Item
• known contra-indications to liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of men, in accordance with risks and safety information included in the latest updated prescribing information for victoza®
boolean
C1301624 (UMLS CUI [1,1])
C1456408 (UMLS CUI [1,2])
C0030305 (UMLS CUI [2])
C0238462 (UMLS CUI [3])
C0027662 (UMLS CUI [4])
C4039247 (UMLS CUI [5])
C1709517 (UMLS CUI [6,1])
C2732208 (UMLS CUI [6,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes, as defined by american diabetes association (ada) criteria
boolean
C0011854 (UMLS CUI [1])
Insulin Dependence | Non-Insulin-Dependent Diabetes Mellitus Treated
Item
insulin dependent or treated type 2 diabetes
boolean
C0021641 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Incretins injectable
Item
current use of other injectable incretins
boolean
C1562292 (UMLS CUI [1,1])
C0086466 (UMLS CUI [1,2])
Diabetic Ketoacidosis
Item
history of diabetes ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Chronic Kidney Disease Advanced | Glomerular Filtration Rate
Item
advanced chronic kidney disease, as defined by glomerular filtration rate (gfr) < 30 ml/min/1.73m2
boolean
C1561643 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0017654 (UMLS CUI [2])
Sign or Symptom Heart failure New York Heart Association Classification
Item
clinical signs or symptoms of new york heart association (nyha) class iii-iv heart failure
boolean
C3540840 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Chronic liver disease
Item
clinical or laboratory evidences of chronic active liver diseases
boolean
C0341439 (UMLS CUI [1])
Communicable Diseases | Chronic infectious disease
Item
acute or chronic infective diseases
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Malignant Neoplasms | Chemotherapy
Item
cancer or chemotherapy
boolean
C0006826 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
current use of systemic corticosteroids or in the 3 months prior this study
boolean
C3653708 (UMLS CUI [1])
Hypersensitivity Liraglutide | Hypersensitivity Suspected Liraglutide | Hypersensitivity Liraglutide Excipient | Hypersensitivity Suspected Liraglutide Excipient | Hypersensitivity Pharmaceutical Products Related | Hypersensitivity Suspected Pharmaceutical Products Related
Item
known or suspected allergy to liraglutide, excipients, or related products
boolean
C0020517 (UMLS CUI [1,1])
C1456408 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1456408 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C1456408 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C1456408 (UMLS CUI [4,3])
C0015237 (UMLS CUI [4,4])
C0020517 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C0439849 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
C0439849 (UMLS CUI [6,4])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant, breast-feeding or the intention of becoming pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Childbearing Potential Contraceptive methods Absent
Item
females of childbearing potential who are not using adequate contraceptive methods
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
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