ID

17274

Beschrijving

Rosiglitazone to Reverse Metabolic Defects in Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00094796

Link

https://clinicaltrials.gov/show/NCT00094796

Trefwoorden

Versies (1)
  1. 03-09-16 03-09-16 -
Geüploaded op

3 september 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type II NCT00094796

Engels

Eligibility Diabetes Mellitus, Type II NCT00094796

1 Formulieren  
Criteria
Beschrijving

Criteria

adults older than 21 years.
Beschrijving

Adult | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
subjects must either have:
Beschrijving

Study Subject Has

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C3539897
1. insulin resistance as defined by a fasting blood sugar of greater than 110mg/dl and less than 126 mg/dl and confirmed with the quicki test.
Beschrijving

Insulin Resistance | Fasting blood glucose measurement | Prothrombin time assay

Datatype

boolean

Alias
UMLS CUI [1]
C0021655
UMLS CUI [2]
C0428568
UMLS CUI [3]
C0033707
2. or the diagnosis of t2dm with a hba1c less than 9%, a fasting insulin level of greater than 6 uiu/ml and a fasting blood glucose level of greater than 125 mg/dl if not on anti-diabetic therapy.
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Glycosylated hemoglobin A | fasting insulin level | Fasting blood glucose measurement | Antidiabetics

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0019018
UMLS CUI [3]
C2016107
UMLS CUI [4]
C0428568
UMLS CUI [5]
C0935929
subject understands protocol and provides written, informed consent
Beschrijving

Study Protocol Comprehension | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [2]
C0021430
patients must demonstrate the capacity for a near maximal to maximal effort on a treadmill as measured by exercise ventilatory threshold. this will be measured by achieving a peak respiratory exchange ratio greater than or equal to 1.00 during the initial and final peak vo2 exercise tests.
Beschrijving

Capacity Treadmill Test Physical Exertion Maximal | Respiratory Exchange Ratio Peak level | treadmill stress test using oxygen uptake protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516240
UMLS CUI [1,2]
C0087110
UMLS CUI [1,3]
C0031807
UMLS CUI [1,4]
C0205289
UMLS CUI [2,1]
C4049826
UMLS CUI [2,2]
C0444505
UMLS CUI [3]
C2059721
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) as determined by echocardiography or unstable coronary disease within the last 3 months.
Beschrijving

Structural disorder of heart Significant | Hypertrophic Cardiomyopathy | Cardiomyopathy, Dilated | Heart valve disease | Echocardiography | Coronary heart disease Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C1290384
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0007193
UMLS CUI [4]
C0018824
UMLS CUI [5]
C0013516
UMLS CUI [6,1]
C0010068
UMLS CUI [6,2]
C0443343
uncontrolled hypertension.
Beschrijving

Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
history of heart failure.
Beschrijving

Heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
left ventricular ejection fraction less than 55% as measured by screening echocardiogram.
Beschrijving

Left ventricular ejection fraction | Electrocardiography

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C1623258
subject physically unable to perform treadmill exercise due to neurologic or orthopedic conditions.
Beschrijving

Treadmill Test Unable Due to nervous system disorder | Treadmill Test Unable Due to orthopedic problem

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087110
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0027765
UMLS CUI [2,1]
C0087110
UMLS CUI [2,2]
C1299582
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0029354
insulin-dependent diabetes mellitus or current use of thiazolidinediones
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Thiazolidinediones

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C1257987
history of adverse events on thiazolidinedione therapy
Beschrijving

Adverse event Thiazolidinediones

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1257987
women of childbearing age unless recent pregnancy test is negative.
Beschrijving

Childbearing Potential Age Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0427780
lactating women.
Beschrijving

Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
serum creatinine greater than 2.5 mg/dl
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
liver transaminase levels greater than 2.5 x upper limit of normal
Beschrijving

Liver Transaminases increased

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0438717
history of cancer in the last 5 years
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
history of treatment for any illness with stem cell transplantation
Beschrijving

Therapeutic procedure Illness Associated with Stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0221423
UMLS CUI [1,3]
C0332281
UMLS CUI [1,4]
C1504389
active inflammatory disease
Beschrijving

Inflammatory disorder

Datatype

boolean

Alias
UMLS CUI [1]
C1290884
enrollment in a any drug studies within the last 30 days
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Diabetes Mellitus, Type II NCT00094796

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Adult | Age
Item
adults older than 21 years.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Study Subject Has
Item
subjects must either have:
boolean
C0681850 (UMLS CUI [1,1])
C3539897 (UMLS CUI [1,2])
Insulin Resistance | Fasting blood glucose measurement | Prothrombin time assay
Item
1. insulin resistance as defined by a fasting blood sugar of greater than 110mg/dl and less than 126 mg/dl and confirmed with the quicki test.
boolean
C0021655 (UMLS CUI [1])
C0428568 (UMLS CUI [2])
C0033707 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent | Glycosylated hemoglobin A | fasting insulin level | Fasting blood glucose measurement | Antidiabetics
Item
2. or the diagnosis of t2dm with a hba1c less than 9%, a fasting insulin level of greater than 6 uiu/ml and a fasting blood glucose level of greater than 125 mg/dl if not on anti-diabetic therapy.
boolean
C0011860 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
C2016107 (UMLS CUI [3])
C0428568 (UMLS CUI [4])
C0935929 (UMLS CUI [5])
Study Protocol Comprehension | Informed Consent
Item
subject understands protocol and provides written, informed consent
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Capacity Treadmill Test Physical Exertion Maximal | Respiratory Exchange Ratio Peak level | treadmill stress test using oxygen uptake protocol
Item
patients must demonstrate the capacity for a near maximal to maximal effort on a treadmill as measured by exercise ventilatory threshold. this will be measured by achieving a peak respiratory exchange ratio greater than or equal to 1.00 during the initial and final peak vo2 exercise tests.
boolean
C1516240 (UMLS CUI [1,1])
C0087110 (UMLS CUI [1,2])
C0031807 (UMLS CUI [1,3])
C0205289 (UMLS CUI [1,4])
C4049826 (UMLS CUI [2,1])
C0444505 (UMLS CUI [2,2])
C2059721 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Structural disorder of heart Significant | Hypertrophic Cardiomyopathy | Cardiomyopathy, Dilated | Heart valve disease | Echocardiography | Coronary heart disease Unstable
Item
significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) as determined by echocardiography or unstable coronary disease within the last 3 months.
boolean
C1290384 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0007194 (UMLS CUI [2])
C0007193 (UMLS CUI [3])
C0018824 (UMLS CUI [4])
C0013516 (UMLS CUI [5])
C0010068 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
Uncontrolled hypertension
Item
uncontrolled hypertension.
boolean
C1868885 (UMLS CUI [1])
Heart failure
Item
history of heart failure.
boolean
C0018801 (UMLS CUI [1])
Left ventricular ejection fraction | Electrocardiography
Item
left ventricular ejection fraction less than 55% as measured by screening echocardiogram.
boolean
C0428772 (UMLS CUI [1])
C1623258 (UMLS CUI [2])
Treadmill Test Unable Due to nervous system disorder | Treadmill Test Unable Due to orthopedic problem
Item
subject physically unable to perform treadmill exercise due to neurologic or orthopedic conditions.
boolean
C0087110 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0027765 (UMLS CUI [1,4])
C0087110 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0029354 (UMLS CUI [2,4])
Diabetes Mellitus, Insulin-Dependent | Thiazolidinediones
Item
insulin-dependent diabetes mellitus or current use of thiazolidinediones
boolean
C0011854 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
Adverse event Thiazolidinediones
Item
history of adverse events on thiazolidinedione therapy
boolean
C0877248 (UMLS CUI [1,1])
C1257987 (UMLS CUI [1,2])
Childbearing Potential Age Pregnancy test negative
Item
women of childbearing age unless recent pregnancy test is negative.
boolean
C3831118 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
Breast Feeding
Item
lactating women.
boolean
C0006147 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine greater than 2.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Liver Transaminases increased
Item
liver transaminase levels greater than 2.5 x upper limit of normal
boolean
C0023884 (UMLS CUI [1,1])
C0438717 (UMLS CUI [1,2])
Malignant Neoplasms
Item
history of cancer in the last 5 years
boolean
C0006826 (UMLS CUI [1])
Therapeutic procedure Illness Associated with Stem cell transplant
Item
history of treatment for any illness with stem cell transplantation
boolean
C0087111 (UMLS CUI [1,1])
C0221423 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C1504389 (UMLS CUI [1,4])
Inflammatory disorder
Item
active inflammatory disease
boolean
C1290884 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
enrollment in a any drug studies within the last 30 days
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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