ID

22087

Description

Iron Depletion Therapy for Type 2 DM and NAFLD; ODM derived from: https://clinicaltrials.gov/show/NCT00230087

Link

https://clinicaltrials.gov/show/NCT00230087

Keywords

Versions (2)
  1. 5/18/17 5/18/17 -
  2. 5/19/17 5/19/17 -
Uploaded on

May 19, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Alcoholic Fatty Liver Disease NCT00230087

English

Eligibility Non-Alcoholic Fatty Liver Disease NCT00230087

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological evidence of nafld and enrollment in nash crn database study
Description

Non-alcoholic Fatty Liver Disease | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C0400966
UMLS CUI [2]
C2348568
type 2 dm treated with diet or a stable dose of non-insulin sensitizing oral hypoglycemic agents for > 3 mo.
Description

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Oral hypoglycemic Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3,1]
C0359086
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
hemoglobin hba1c level ≤ 8 %
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
serum alt levels ≥1.3 x uln
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
between 18-65 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hereditary hemochromatosis or hepatic iron overload defined as any of the following:
Description

Hereditary hemochromatosis | Iron Overload Hepatic

Data type

boolean

Alias
UMLS CUI [1]
C0392514
UMLS CUI [2,1]
C0282193
UMLS CUI [2,2]
C0205054
2+ iron on hepatic iron staining
Description

Iron Positive | Iron Hepatic Staining

Data type

boolean

Alias
UMLS CUI [1,1]
C0302583
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0302583
UMLS CUI [2,2]
C0205054
UMLS CUI [2,3]
C0487602
hepatic iron index ≥ 1.9
Description

Hepatic iron index

Data type

boolean

Alias
UMLS CUI [1]
C1954806
c282y homozygous or c282y/h63d compound heterozygous hfe genotype
Description

hfe gene c282y variant | hfe gene h63d variant

Data type

boolean

Alias
UMLS CUI [1]
C3468755
UMLS CUI [2]
C3468756
use of insulin or thiazolidinediones for the treatment of diabetes
Description

Insulin | Thiazolidinediones | Diabetes Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C1257987
UMLS CUI [3]
C3274787
use of anti-nash drugs (thiazolidinediones, vitamin e, udca, sam-e, betaine, milk thistle, gemfibrozil, anti-tnf therapies, probiotics)
Description

Pharmaceutical Preparations Against Nonalcoholic Steatohepatitis | Thiazolidinediones | Vitamin E | Ursodiol | S-Adenosylmethionine | Betaine | Milk thistle extract | Gemfibrozil | anti-tumor necrosis factor therapy | Probiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C3241937
UMLS CUI [2]
C1257987
UMLS CUI [3]
C0042874
UMLS CUI [4]
C0042105
UMLS CUI [5]
C0036002
UMLS CUI [6]
C0005304
UMLS CUI [7]
C0937640
UMLS CUI [8]
C0017245
UMLS CUI [9]
C0281481
UMLS CUI [10]
C0525033
serum ferritin <50μg/l
Description

Serum ferritin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0696113
serum transferrin-iron saturation <10 %
Description

Transferrin saturation measurement

Data type

boolean

Alias
UMLS CUI [1]
C1277709
hemoglobin <10 mg/l
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
hematocrit <38 %
Description

Hematocrit level

Data type

boolean

Alias
UMLS CUI [1]
C0518014
voluntary blood donation or therapeutic phlebotomy within the previous twelve months (except routine lab tests)
Description

Blood Donation Voluntary | Venesection

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0439656
UMLS CUI [2]
C0684257
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior history of coronary artery disease, myocardial infarction, exertional dyspnea or chronic chest pain at rest.
Description

Coronary Artery Disease | Myocardial Infarction | Dyspnea on exertion | Chest pain at rest chronic

Data type

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0231807
UMLS CUI [4,1]
C0392685
UMLS CUI [4,2]
C0205191
evidence of myocardial infarction as determined by an ecg
Description

Electrocardiogram: myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C0428953
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Similar models

Eligibility Non-Alcoholic Fatty Liver Disease NCT00230087

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-alcoholic Fatty Liver Disease | Study Subject Participation Status
Item
histological evidence of nafld and enrollment in nash crn database study
boolean
C0400966 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Oral hypoglycemic Dose Stable
Item
type 2 dm treated with diet or a stable dose of non-insulin sensitizing oral hypoglycemic agents for > 3 mo.
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0359086 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Glucohemoglobin measurement
Item
hemoglobin hba1c level ≤ 8 %
boolean
C0202054 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
serum alt levels ≥1.3 x uln
boolean
C0201836 (UMLS CUI [1])
Age
Item
between 18-65 years of age
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hereditary hemochromatosis | Iron Overload Hepatic
Item
hereditary hemochromatosis or hepatic iron overload defined as any of the following:
boolean
C0392514 (UMLS CUI [1])
C0282193 (UMLS CUI [2,1])
C0205054 (UMLS CUI [2,2])
Iron Positive | Iron Hepatic Staining
Item
2+ iron on hepatic iron staining
boolean
C0302583 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0302583 (UMLS CUI [2,1])
C0205054 (UMLS CUI [2,2])
C0487602 (UMLS CUI [2,3])
Hepatic iron index
Item
hepatic iron index ≥ 1.9
boolean
C1954806 (UMLS CUI [1])
hfe gene c282y variant | hfe gene h63d variant
Item
c282y homozygous or c282y/h63d compound heterozygous hfe genotype
boolean
C3468755 (UMLS CUI [1])
C3468756 (UMLS CUI [2])
Insulin | Thiazolidinediones | Diabetes Therapy
Item
use of insulin or thiazolidinediones for the treatment of diabetes
boolean
C0021641 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
C3274787 (UMLS CUI [3])
Pharmaceutical Preparations Against Nonalcoholic Steatohepatitis | Thiazolidinediones | Vitamin E | Ursodiol | S-Adenosylmethionine | Betaine | Milk thistle extract | Gemfibrozil | anti-tumor necrosis factor therapy | Probiotics
Item
use of anti-nash drugs (thiazolidinediones, vitamin e, udca, sam-e, betaine, milk thistle, gemfibrozil, anti-tnf therapies, probiotics)
boolean
C0013227 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C3241937 (UMLS CUI [1,3])
C1257987 (UMLS CUI [2])
C0042874 (UMLS CUI [3])
C0042105 (UMLS CUI [4])
C0036002 (UMLS CUI [5])
C0005304 (UMLS CUI [6])
C0937640 (UMLS CUI [7])
C0017245 (UMLS CUI [8])
C0281481 (UMLS CUI [9])
C0525033 (UMLS CUI [10])
Serum ferritin measurement
Item
serum ferritin <50μg/l
boolean
C0696113 (UMLS CUI [1])
Transferrin saturation measurement
Item
serum transferrin-iron saturation <10 %
boolean
C1277709 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin <10 mg/l
boolean
C0518015 (UMLS CUI [1])
Hematocrit level
Item
hematocrit <38 %
boolean
C0518014 (UMLS CUI [1])
Blood Donation Voluntary | Venesection
Item
voluntary blood donation or therapeutic phlebotomy within the previous twelve months (except routine lab tests)
boolean
C0005794 (UMLS CUI [1,1])
C0439656 (UMLS CUI [1,2])
C0684257 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Coronary Artery Disease | Myocardial Infarction | Dyspnea on exertion | Chest pain at rest chronic
Item
prior history of coronary artery disease, myocardial infarction, exertional dyspnea or chronic chest pain at rest.
boolean
C1956346 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0231807 (UMLS CUI [3])
C0392685 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
Electrocardiogram: myocardial infarction
Item
evidence of myocardial infarction as determined by an ecg
boolean
C0428953 (UMLS CUI [1])
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