ID

19411

Description

WelChol® and Insulin in Treating Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00151749

Link

https://clinicaltrials.gov/show/NCT00151749

Keywords

Versions (1)
  1. 12/29/16 12/29/16 -
Uploaded on

December 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00151749

English

Eligibility Type 2 Diabetes NCT00151749

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ages 18 - 75 years, inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
stable insulin therapy for 6 weeks
Description

Insulin regime Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205360
stable dose of any other antidiabetic medications for 90 days
Description

Antidiabetics Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
hemoglobin a1c value between 7.5% to 9.5%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
c peptide greater than 0.5 ng/ml
Description

C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202100
prescribed ada diet
Description

Diet prescribed

Data type

boolean

Alias
UMLS CUI [1,1]
C0012155
UMLS CUI [1,2]
C0278329
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of type 1 diabetes or ketoacidosis
Description

Diabetes Mellitus, Insulin-Dependent | Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0220982
history of pancreatitis
Description

Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
allergy or toxic response to colesevelam or any of its components
Description

Hypersensitivity Colesevelam | Toxic reaction Colesevelam | Hypersensitivity Colesevelam Component | Toxic reaction Colesevelam Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0541155
UMLS CUI [2,1]
C0542243
UMLS CUI [2,2]
C0541155
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0541155
UMLS CUI [3,3]
C1705248
UMLS CUI [4,1]
C0542243
UMLS CUI [4,2]
C0541155
UMLS CUI [4,3]
C1705248
serum ldl-c less than 60 mg/dl
Description

Serum LDL cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428474
serum tg greater than 500 mg/dl
Description

Serum thyroglobulin level

Data type

boolean

Alias
UMLS CUI [1]
C1271701
body mass index (bmi) greater than 45 kg/m2-
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
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Similar models

Eligibility Type 2 Diabetes NCT00151749

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
ages 18 - 75 years, inclusive
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Insulin regime Stable
Item
stable insulin therapy for 6 weeks
boolean
C0557978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Antidiabetics Dose Stable
Item
stable dose of any other antidiabetic medications for 90 days
boolean
C0935929 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Glucohemoglobin measurement
Item
hemoglobin a1c value between 7.5% to 9.5%
boolean
C0202054 (UMLS CUI [1])
C-peptide measurement
Item
c peptide greater than 0.5 ng/ml
boolean
C0202100 (UMLS CUI [1])
Diet prescribed
Item
prescribed ada diet
boolean
C0012155 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Ketoacidosis
Item
history of type 1 diabetes or ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0220982 (UMLS CUI [2])
Pancreatitis
Item
history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Hypersensitivity Colesevelam | Toxic reaction Colesevelam | Hypersensitivity Colesevelam Component | Toxic reaction Colesevelam Component
Item
allergy or toxic response to colesevelam or any of its components
boolean
C0020517 (UMLS CUI [1,1])
C0541155 (UMLS CUI [1,2])
C0542243 (UMLS CUI [2,1])
C0541155 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0541155 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C0542243 (UMLS CUI [4,1])
C0541155 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
Serum LDL cholesterol measurement
Item
serum ldl-c less than 60 mg/dl
boolean
C0428474 (UMLS CUI [1])
Serum thyroglobulin level
Item
serum tg greater than 500 mg/dl
boolean
C1271701 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) greater than 45 kg/m2-
boolean
C1305855 (UMLS CUI [1])
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