ID

23930

Description

Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM); ODM derived from: https://clinicaltrials.gov/show/NCT00529191

Link

https://clinicaltrials.gov/show/NCT00529191

Keywords

Versions (1)
  1. 7/18/17 7/18/17 -
Uploaded on

July 18, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes NCT00529191

English

Eligibility Type 1 Diabetes NCT00529191

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
individuals 10-19 years of age (tanner stage ii or greater),
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1,1]
C0429602
UMLS CUI [1,2]
C0429602
UMLS CUI [1,3]
C0001779
the presence of one or more serum antibodies to islet cell proteins (anti- glutamic acid decarboxylase [gad], islet antigen 2 or insulin autoantibodies) as assessed in standard practice,
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1,1]
C1522529
UMLS CUI [1,2]
C3203592
diagnosis of t1dm within the 8 weeks prior to study entry
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C0011854
peak stimulated c-peptide level >0.2pmol/ml following mixed meal tolerance test (mmtt) performed at least 3 weeks after diagnosis,
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1]
C0202100
females of reproductive potential must not plan on conceiving a child during the treatment program, and agree to use a medically accepted form of contraception
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects currently receiving cyclosporine, fibric acid derivatives, niacin (nicotinic acid), erythromycin, clarythromycin, nefazodone, itraconazole, ketoconazole or protease inhibitors,
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1,1]
C0010592
UMLS CUI [1,2]
C4020588
UMLS CUI [1,3]
C0027996
UMLS CUI [1,4]
C0014806
UMLS CUI [1,5]
C0055856
UMLS CUI [1,6]
C0068485
UMLS CUI [1,7]
C0022625
UMLS CUI [1,8]
C0033607
UMLS CUI [1,9]
C0064113
pregnancy or breast-feeding,
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
clinical aids, aids related syndrome (ars) or known positive hiv serology,
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1,1]
C0001175
UMLS CUI [1,2]
C0019682
subjects treated with immunosuppressive therapy in the past 12 months,
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1]
C0021079
subjects receiving glucocorticoid therapy or therapy other than insulin that is likely to affect glucose homeostasis (such as sulfonylureas, thiazolidinediones, metformin or amylin),
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1,1]
C0744425
UMLS CUI [1,2]
C1326961
subjects with other autoimmune diseases, except autoimmune thyroid disease,
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1]
C0004364
subjects with any illness that might complicate diabetes management or preclude treatment with atorvastatin,
Description

ID.12

Data type

boolean

Alias
UMLS CUI [1]
C0221423
transplant recipients,
Description

ID.13

Data type

boolean

Alias
UMLS CUI [1]
C0376387
evidence of liver dysfunction or myopathy
Description

ID.14

Data type

boolean

Alias
UMLS CUI [1,1]
C0026848
UMLS CUI [1,2]
C0086565
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Similar models

Eligibility Type 1 Diabetes NCT00529191

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
individuals 10-19 years of age (tanner stage ii or greater),
boolean
C0429602 (UMLS CUI [1,1])
C0429602 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
ID.2
Item
the presence of one or more serum antibodies to islet cell proteins (anti- glutamic acid decarboxylase [gad], islet antigen 2 or insulin autoantibodies) as assessed in standard practice,
boolean
C1522529 (UMLS CUI [1,1])
C3203592 (UMLS CUI [1,2])
ID.3
Item
diagnosis of t1dm within the 8 weeks prior to study entry
boolean
C0011854 (UMLS CUI [1])
ID.4
Item
peak stimulated c-peptide level >0.2pmol/ml following mixed meal tolerance test (mmtt) performed at least 3 weeks after diagnosis,
boolean
C0202100 (UMLS CUI [1])
ID.5
Item
females of reproductive potential must not plan on conceiving a child during the treatment program, and agree to use a medically accepted form of contraception
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.6
Item
subjects currently receiving cyclosporine, fibric acid derivatives, niacin (nicotinic acid), erythromycin, clarythromycin, nefazodone, itraconazole, ketoconazole or protease inhibitors,
boolean
C0010592 (UMLS CUI [1,1])
C4020588 (UMLS CUI [1,2])
C0027996 (UMLS CUI [1,3])
C0014806 (UMLS CUI [1,4])
C0055856 (UMLS CUI [1,5])
C0068485 (UMLS CUI [1,6])
C0022625 (UMLS CUI [1,7])
C0033607 (UMLS CUI [1,8])
C0064113 (UMLS CUI [1,9])
ID.7
Item
pregnancy or breast-feeding,
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
ID.8
Item
clinical aids, aids related syndrome (ars) or known positive hiv serology,
boolean
C0001175 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
ID.9
Item
subjects treated with immunosuppressive therapy in the past 12 months,
boolean
C0021079 (UMLS CUI [1])
ID.10
Item
subjects receiving glucocorticoid therapy or therapy other than insulin that is likely to affect glucose homeostasis (such as sulfonylureas, thiazolidinediones, metformin or amylin),
boolean
C0744425 (UMLS CUI [1,1])
C1326961 (UMLS CUI [1,2])
ID.11
Item
subjects with other autoimmune diseases, except autoimmune thyroid disease,
boolean
C0004364 (UMLS CUI [1])
ID.12
Item
subjects with any illness that might complicate diabetes management or preclude treatment with atorvastatin,
boolean
C0221423 (UMLS CUI [1])
ID.13
Item
transplant recipients,
boolean
C0376387 (UMLS CUI [1])
ID.14
Item
evidence of liver dysfunction or myopathy
boolean
C0026848 (UMLS CUI [1,1])
C0086565 (UMLS CUI [1,2])
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