ID

37385

Beschreibung

Efficacy Study of Diacerein on Glycemic Control and Liver Fat in Type 2 Diabetes Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT02242149

Link

https://clinicaltrials.gov/show/NCT02242149

Stichworte

Versionen (1)
  1. 21.07.19 21.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. Juli 2019

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes. NCT02242149

Englisch

Eligibility Type 2 Diabetes. NCT02242149

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes.
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
presence of liver steatosis diagnosed by ultrasound or transient elastography (fibroscan®)
Beschreibung

Fatty Liver Ultrasonography | Fatty Liver Transient elastography | Fatty Liver Fibroscan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0041618
UMLS CUI [2,1]
C0015695
UMLS CUI [2,2]
C2748260
UMLS CUI [3,1]
C0015695
UMLS CUI [3,2]
C4522043
age 30-75 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
hba1c 7.5- 9.5 for at least 8 weeks prior to screening.
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
stable diabetes therapeutic regimen consisting of either diet, oral hypoglycemic agents with or without insulin for 8 weeks prior to randomization.
Beschreibung

Diabetes Therapy Stable | Diet therapy | Oral hypoglycemic | Insulin | Insulin Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274787
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0359086
UMLS CUI [4]
C0021641
UMLS CUI [5,1]
C0021641
UMLS CUI [5,2]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
body mass index > 40 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
serum creatinine ≥180mmol/l or estimated glomerular filtration rate < 30 ml/min.
Beschreibung

Creatinine measurement, serum | Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C3811844
presence of any serious concomitant disease, such as a pulmonary disease or malignant disorders.
Beschreibung

Comorbidity Serious | Lung disease | Malignant disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0442867
current daily alcohol ingestion ≥20 g.
Beschreibung

Alcohol consumption g/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0439417
hepatotoxic drugs.
Beschreibung

Pharmaceutical Preparations Hepatotoxic effect

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0235378
presence of other chronic liver disease other than nonalcoholic fatty liver disease, including hepatitis b virus and hepatitis c virus infection, hemochromatosis, wilson's disease, alfa-1 antitrypsin deficiency, autoimmune hepatitis.
Beschreibung

Chronic liver disease | Exception Non-alcoholic Fatty Liver Disease | Hepatitis B | Hepatitis C | Hemochromatosis | Wilson's disease | alpha 1-Antitrypsin Deficiency | Hepatitis Autoimmune

Datentyp

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0400966
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
UMLS CUI [5]
C0018995
UMLS CUI [6]
C0019202
UMLS CUI [7]
C0221757
UMLS CUI [8,1]
C0019158
UMLS CUI [8,2]
C0004364
women seeking pregnancy.
Beschreibung

Gender | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0032992
current use or previous use within 6 months of vitamin e or pioglitazone
Beschreibung

Vitamin E | pioglitazone

Datentyp

boolean

Alias
UMLS CUI [1]
C0042874
UMLS CUI [2]
C0071097
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Ähnliche Modelle

Eligibility Type 2 Diabetes. NCT02242149

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
Fatty Liver Ultrasonography | Fatty Liver Transient elastography | Fatty Liver Fibroscan
Item
presence of liver steatosis diagnosed by ultrasound or transient elastography (fibroscan®)
boolean
C0015695 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C0015695 (UMLS CUI [2,1])
C2748260 (UMLS CUI [2,2])
C0015695 (UMLS CUI [3,1])
C4522043 (UMLS CUI [3,2])
Age
Item
age 30-75 years.
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c 7.5- 9.5 for at least 8 weeks prior to screening.
boolean
C0474680 (UMLS CUI [1])
Diabetes Therapy Stable | Diet therapy | Oral hypoglycemic | Insulin | Insulin Absent
Item
stable diabetes therapeutic regimen consisting of either diet, oral hypoglycemic agents with or without insulin for 8 weeks prior to randomization.
boolean
C3274787 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0012159 (UMLS CUI [2])
C0359086 (UMLS CUI [3])
C0021641 (UMLS CUI [4])
C0021641 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Body mass index
Item
body mass index > 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Creatinine measurement, serum | Estimated Glomerular Filtration Rate
Item
serum creatinine ≥180mmol/l or estimated glomerular filtration rate < 30 ml/min.
boolean
C0201976 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Comorbidity Serious | Lung disease | Malignant disease
Item
presence of any serious concomitant disease, such as a pulmonary disease or malignant disorders.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2])
C0442867 (UMLS CUI [3])
Alcohol consumption g/day
Item
current daily alcohol ingestion ≥20 g.
boolean
C0001948 (UMLS CUI [1,1])
C0439417 (UMLS CUI [1,2])
Pharmaceutical Preparations Hepatotoxic effect
Item
hepatotoxic drugs.
boolean
C0013227 (UMLS CUI [1,1])
C0235378 (UMLS CUI [1,2])
Chronic liver disease | Exception Non-alcoholic Fatty Liver Disease | Hepatitis B | Hepatitis C | Hemochromatosis | Wilson's disease | alpha 1-Antitrypsin Deficiency | Hepatitis Autoimmune
Item
presence of other chronic liver disease other than nonalcoholic fatty liver disease, including hepatitis b virus and hepatitis c virus infection, hemochromatosis, wilson's disease, alfa-1 antitrypsin deficiency, autoimmune hepatitis.
boolean
C0341439 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0400966 (UMLS CUI [2,2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0018995 (UMLS CUI [5])
C0019202 (UMLS CUI [6])
C0221757 (UMLS CUI [7])
C0019158 (UMLS CUI [8,1])
C0004364 (UMLS CUI [8,2])
Gender | Pregnancy, Planned
Item
women seeking pregnancy.
boolean
C0079399 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Vitamin E | pioglitazone
Item
current use or previous use within 6 months of vitamin e or pioglitazone
boolean
C0042874 (UMLS CUI [1])
C0071097 (UMLS CUI [2])
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