ID

37377

Descripción

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

Palabras clave

Versiones (1)
  1. 20/7/19 20/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de julio de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02014740

Inglés

Eligibility Type 2 Diabetes NCT02014740

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

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

Hemoglobin A1c measurement

Tipo de datos

boolean

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

Body mass index

Tipo de datos

boolean

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

Metformin pre treatment

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descripción

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®
Descripción

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

Tipo de datos

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
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

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

Insulin Dependence | Non-Insulin-Dependent Diabetes Mellitus Treated

Tipo de datos

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
Descripción

Incretins injectable

Tipo de datos

boolean

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

Diabetic Ketoacidosis

Tipo de datos

boolean

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

Chronic Kidney Disease Advanced | Glomerular Filtration Rate

Tipo de datos

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
Descripción

Sign or Symptom Heart failure New York Heart Association Classification

Tipo de datos

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
Descripción

Chronic liver disease

Tipo de datos

boolean

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

Communicable Diseases | Chronic infectious disease

Tipo de datos

boolean

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

Malignant Neoplasms | Chemotherapy

Tipo de datos

boolean

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

CORTICOSTEROIDS FOR SYSTEMIC USE

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de datos

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
Descripción

Childbearing Potential Contraceptive methods Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
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Similar models

Eligibility Type 2 Diabetes NCT02014740

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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