ID

31768

Descripción

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

Palabras clave

Versiones (2)
  1. 26/9/18 26/9/18 -
  2. 27/9/18 27/9/18 - Sarah Riepenhausen
Titular de derechos de autor

Centre hospitalier de l'Université de Montréal (CHUM)

Subido en

27 de septiembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Nonalcoholic Fatty Liver Disease NCT01399645

Inglés

Eligibility Nonalcoholic Fatty Liver Disease NCT01399645

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
are ambulatory,
Descripción

Ambulatory

Tipo de datos

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,
Descripción

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

Tipo de datos

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,
Descripción

Abdominal girth

Tipo de datos

boolean

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

Language comprehension in french/english

Tipo de datos

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.
Descripción

Comprehension and Willingness to consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

Contraindication for MRI (metallic implants, pacemaker, claustrophobia)

Tipo de datos

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,
Descripción

Diabetes typ 1, episodes of ketoacidosis

Tipo de datos

boolean

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

Severe disease, malignant disorder

Tipo de datos

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,
Descripción

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

Tipo de datos

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,
Descripción

Received insulin 3 months prior to screening

Tipo de datos

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,
Descripción

Serum creatine, estimated GFR

Tipo de datos

boolean

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

Pregnancy planned

Tipo de datos

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,
Descripción

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

Tipo de datos

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,
Descripción

Current/previous oral/injectable corticosteroids use

Tipo de datos

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.
Descripción

Alcohol abuse

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0560578
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Similar models

Eligibility Nonalcoholic Fatty Liver Disease NCT01399645

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