ID

17291

Description

Effects of Fatty Acid Delivery on Heart Metabolism and Function in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00577590

Link

https://clinicaltrials.gov/show/NCT00577590

Keywords

Versions (1)
  1. 9/4/16 9/4/16 -
Uploaded on

September 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type II NCT00577590

English

Eligibility Diabetes Mellitus, Type II NCT00577590

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
meets americans with disabilities act (ada) criteria for t2dm; if newly diagnosed, must have fasting blood glucose greater than 126 mg/dl on two occasions, a random blood glucose greater than 200 mg/dl with symptoms, or a diagnostic oral glucose tolerance test
Description

American | Diabetes Mellitus, Non-Insulin-Dependent | Fasting blood glucose measurement Quantity | Random blood glucose measurement Associated with Symptoms | Oral Glucose Tolerance Test

Data type

boolean

Alias
UMLS CUI [1]
C0596070
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0428568
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0428567
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C1457887
UMLS CUI [5]
C0029161
weight of less than 350 pounds
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
hemoglobin a1c of equal to or less than 7.5% at study entry or willing to go on one of the following therapies to achieve necessary percentage: metformin monotherapy greater than 1000 mg daily for at least 30 days or metformin greater than 1000 mg daily plus any combination of sulfonylurea, glipizide, or alpha-glucosidase inhibitor
Description

Glycosylated hemoglobin A | Metformin Quantity per day | Sulfonylurea | Glipizide | alpha-Glucosidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0019018
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0439505
UMLS CUI [3]
C0038766
UMLS CUI [4]
C0017642
UMLS CUI [5]
C1299007
blood pressure less than 140/90 mm hg at study entry
Description

Blood Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0005823
ldl level less than 130 mg/dl if on stable lipid lowering regimen
Description

Serum LDL cholesterol measurement | Lipid-lowering therapy Stable

Data type

boolean

Alias
UMLS CUI [1]
C0428474
UMLS CUI [2,1]
C0585943
UMLS CUI [2,2]
C0205360
willing to undergo normal rest/stress (treadmill or dobutamine) echocardiogram
Description

stress test echocardiogram at rest | Echocardiography, Stress | Treadmill Test | Dobutamine measurement

Data type

boolean

Alias
UMLS CUI [1]
C2035956
UMLS CUI [2]
C0920208
UMLS CUI [3]
C0087110
UMLS CUI [4]
C1266511
if currently taking thyroid replacement therapy, must be on a stable dose of thyroid replacement and must have a thyroid function blood test that is in the normal range
Description

Thyroid hormone replacement therapy | Thyroid preparations Dose Stable | Thyroid function tests normal

Data type

boolean

Alias
UMLS CUI [1]
C2242640
UMLS CUI [2,1]
C0279175
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0729749
willing to use an effective form of birth control throughout the study
Description

Contraceptive methods Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
received therapy with an insulin sensitizer of the thiazolidinedione class within 6 months prior to study entry
Description

Insulin regime | Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2]
C1257987
required insulin therapy for more than 2 weeks in the year prior to study entry
Description

Insulin regime Duration of treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0444921
history of angina, heart attack, coronary artery bypass grafting (cabg), stroke, congestive heart failure (chf), or peripheral vascular disease (pvd)
Description

Angina Pectoris | Myocardial Infarction | Coronary Artery Bypass Surgery | Cerebrovascular accident | Congestive heart failure | Peripheral Vascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0010055
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0085096
known coronary artery disease (cad) with residual lesions of greater than 50%
Description

Coronary Artery Disease | Residual Lesion Percentage

Data type

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1609982
UMLS CUI [2,3]
C0439165
current smoker
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
use or expected use of corticosteroids in any form
Description

Adrenal Cortex Hormones | Adrenal Cortex Hormones Use of Expected

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C1517001
serum triglycerides greater than 400 mg/dl on a fasting sample at study entry
Description

Serum Triglyceride Measurement Sample Fasting

Data type

boolean

Alias
UMLS CUI [1,1]
C0542495
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C0015663
any contraindication to a thiazolidinedione (tzd) insulin sensitizer, metformin, or other drugs likely to be used during the study
Description

Medical contraindication Thiazolidinediones | Medical contraindication Metformin | Medical contraindication Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1257987
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0013227
liver disease with liver function test (lft) greater than 2 times the upper limit of normal (uln)
Description

Liver disease | Liver Function Tests

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023901
serum creatinine greater than 1.5 mg/dl for women and 1.6 mg/dl for men or greater than 2+ proteinuria on urine dipstick
Description

Creatinine measurement, serum | Gender | Proteinuria | Urine dipstick test

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0033687
UMLS CUI [4]
C0430370
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Similar models

Eligibility Diabetes Mellitus, Type II NCT00577590

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
American | Diabetes Mellitus, Non-Insulin-Dependent | Fasting blood glucose measurement Quantity | Random blood glucose measurement Associated with Symptoms | Oral Glucose Tolerance Test
Item
meets americans with disabilities act (ada) criteria for t2dm; if newly diagnosed, must have fasting blood glucose greater than 126 mg/dl on two occasions, a random blood glucose greater than 200 mg/dl with symptoms, or a diagnostic oral glucose tolerance test
boolean
C0596070 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0428568 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0428567 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C1457887 (UMLS CUI [4,3])
C0029161 (UMLS CUI [5])
Body Weight
Item
weight of less than 350 pounds
boolean
C0005910 (UMLS CUI [1])
Glycosylated hemoglobin A | Metformin Quantity per day | Sulfonylurea | Glipizide | alpha-Glucosidase Inhibitors
Item
hemoglobin a1c of equal to or less than 7.5% at study entry or willing to go on one of the following therapies to achieve necessary percentage: metformin monotherapy greater than 1000 mg daily for at least 30 days or metformin greater than 1000 mg daily plus any combination of sulfonylurea, glipizide, or alpha-glucosidase inhibitor
boolean
C0019018 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0439505 (UMLS CUI [2,3])
C0038766 (UMLS CUI [3])
C0017642 (UMLS CUI [4])
C1299007 (UMLS CUI [5])
Blood Pressure
Item
blood pressure less than 140/90 mm hg at study entry
boolean
C0005823 (UMLS CUI [1])
Serum LDL cholesterol measurement | Lipid-lowering therapy Stable
Item
ldl level less than 130 mg/dl if on stable lipid lowering regimen
boolean
C0428474 (UMLS CUI [1])
C0585943 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
stress test echocardiogram at rest | Echocardiography, Stress | Treadmill Test | Dobutamine measurement
Item
willing to undergo normal rest/stress (treadmill or dobutamine) echocardiogram
boolean
C2035956 (UMLS CUI [1])
C0920208 (UMLS CUI [2])
C0087110 (UMLS CUI [3])
C1266511 (UMLS CUI [4])
Thyroid hormone replacement therapy | Thyroid preparations Dose Stable | Thyroid function tests normal
Item
if currently taking thyroid replacement therapy, must be on a stable dose of thyroid replacement and must have a thyroid function blood test that is in the normal range
boolean
C2242640 (UMLS CUI [1])
C0279175 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0729749 (UMLS CUI [3])
Contraceptive methods Willing
Item
willing to use an effective form of birth control throughout the study
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Insulin regime | Thiazolidinediones
Item
received therapy with an insulin sensitizer of the thiazolidinedione class within 6 months prior to study entry
boolean
C0557978 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
Insulin regime Duration of treatment
Item
required insulin therapy for more than 2 weeks in the year prior to study entry
boolean
C0557978 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
Angina Pectoris | Myocardial Infarction | Coronary Artery Bypass Surgery | Cerebrovascular accident | Congestive heart failure | Peripheral Vascular Disease
Item
history of angina, heart attack, coronary artery bypass grafting (cabg), stroke, congestive heart failure (chf), or peripheral vascular disease (pvd)
boolean
C0002962 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0085096 (UMLS CUI [6])
Coronary Artery Disease | Residual Lesion Percentage
Item
known coronary artery disease (cad) with residual lesions of greater than 50%
boolean
C1956346 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1609982 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Tobacco use
Item
current smoker
boolean
C0543414 (UMLS CUI [1])
Adrenal Cortex Hormones | Adrenal Cortex Hormones Use of Expected
Item
use or expected use of corticosteroids in any form
boolean
C0001617 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
Serum Triglyceride Measurement Sample Fasting
Item
serum triglycerides greater than 400 mg/dl on a fasting sample at study entry
boolean
C0542495 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C0015663 (UMLS CUI [1,3])
Medical contraindication Thiazolidinediones | Medical contraindication Metformin | Medical contraindication Pharmaceutical Preparations
Item
any contraindication to a thiazolidinedione (tzd) insulin sensitizer, metformin, or other drugs likely to be used during the study
boolean
C1301624 (UMLS CUI [1,1])
C1257987 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
Liver disease | Liver Function Tests
Item
liver disease with liver function test (lft) greater than 2 times the upper limit of normal (uln)
boolean
C0023895 (UMLS CUI [1])
C0023901 (UMLS CUI [2])
Creatinine measurement, serum | Gender | Proteinuria | Urine dipstick test
Item
serum creatinine greater than 1.5 mg/dl for women and 1.6 mg/dl for men or greater than 2+ proteinuria on urine dipstick
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0033687 (UMLS CUI [3])
C0430370 (UMLS CUI [4])
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