ID

15254

Description

A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patients on a Controlled Diet; ODM derived from: https://clinicaltrials.gov/show/NCT00231530

Link

https://clinicaltrials.gov/show/NCT00231530

Keywords

Versions (1)
  1. 5/23/16 5/23/16 -
Uploaded on

May 23, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Obesity NCT00231530

English

Eligibility Obesity NCT00231530

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00231530
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
body mass index >= 27 and < 50
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
diagnosis of type 2 diabetes according to either swedish guideline or the american diabetes association (ada) criteria
Description

type 2 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hba1c < 10.5% at enrollment
Description

hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
no previous oral antidiabetic medication or insulin therapy
Description

no previous oral antidiabetic medication or insulin therapy

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0021641
stable body weight
Description

stable body weight

Data type

boolean

Alias
UMLS CUI [1]
C0517386
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test)
Description

postmenopausal or contraceptive use

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C1999124
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known contraindication or hypersensitivity to topiramate
Description

hypersensitivity to topiramate

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0076829
UMLS CUI [1,3]
C0020517
fasting plasma glucose (fpg) >= 13.1 millimolesl/liter (240 milligrams/deciliter) at baseline, visit 4 (week 0)
Description

fasting plasma glucose

Data type

boolean

Alias
UMLS CUI [1]
C0583513
hba1c of >10.5% at enrollment
Description

Hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
history of severe recurrent hypoglycemic episodes prior to study entry
Description

severe recurrent hypoglycemic episodes

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2945760
use of any systemic corticosteroids within 30 days of enrollment
Description

systemic corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C2825233
diagnosed type 1 diabetes
Description

type 1 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011854
history of significant cardiovascular disease, uncontrolled thyroid disease, or kidney stones
Description

cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0040128
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0022650
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Similar models

Eligibility Obesity NCT00231530

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00231530
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
BMI
Item
body mass index >= 27 and < 50
boolean
C1305855 (UMLS CUI [1])
type 2 diabetes
Item
diagnosis of type 2 diabetes according to either swedish guideline or the american diabetes association (ada) criteria
boolean
C0011860 (UMLS CUI [1])
hba1c
Item
hba1c < 10.5% at enrollment
boolean
C0019018 (UMLS CUI [1])
no previous oral antidiabetic medication or insulin therapy
Item
no previous oral antidiabetic medication or insulin therapy
boolean
C0935929 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
stable body weight
Item
stable body weight
boolean
C0517386 (UMLS CUI [1])
postmenopausal or contraceptive use
Item
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test)
boolean
C0232970 (UMLS CUI [1])
C1999124 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
hypersensitivity to topiramate
Item
known contraindication or hypersensitivity to topiramate
boolean
C1301624 (UMLS CUI [1,1])
C0076829 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
fasting plasma glucose
Item
fasting plasma glucose (fpg) >= 13.1 millimolesl/liter (240 milligrams/deciliter) at baseline, visit 4 (week 0)
boolean
C0583513 (UMLS CUI [1])
Hba1c
Item
hba1c of >10.5% at enrollment
boolean
C0019018 (UMLS CUI [1])
severe recurrent hypoglycemic episodes
Item
history of severe recurrent hypoglycemic episodes prior to study entry
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
systemic corticosteroids
Item
use of any systemic corticosteroids within 30 days of enrollment
boolean
C2825233 (UMLS CUI [1])
type 1 diabetes
Item
diagnosed type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
cardiovascular disease
Item
history of significant cardiovascular disease, uncontrolled thyroid disease, or kidney stones
boolean
C0007222 (UMLS CUI [1])
C0040128 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0022650 (UMLS CUI [3])
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