ID

13887

Description

Insulin Receptor Substrate 1 (IRS-1) Regulation in Insulin Resistance; ODM derived from: https://clinicaltrials.gov/show/NCT01240252

Link

https://clinicaltrials.gov/show/NCT01240252

Keywords

Versions (1)
  1. 3/13/16 3/13/16 -
Uploaded on

March 13, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01240252

English

Eligibility Type 2 Diabetes Mellitus NCT01240252

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 30-65 y
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
healthy lean, obese, or known type 2 diabetic
Description

diabetes mellitus type 2

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0441730
body mass index (bmi) less than 36
Description

body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
all nondiabetic subjects must have normal oral glucose tolerance
Description

Oral Glucose Tolerance Test

Data type

boolean

Alias
UMLS CUI [1]
C0029161
subjects must have the following laboratory values:
Description

laboratory parameters

Data type

boolean

Alias
UMLS CUI [1]
C0022885
1. hematocrit ≥ 35 vol%
Description

hematocrit

Data type

boolean

Alias
UMLS CUI [1]
C0518014
2. serum creatinine ≤ 1.6 mg/dl
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
3. aspartate aminotransferase (ast) (sgot)< 2 times upper limit of normal
Description

aspartate aminotransferase

Data type

boolean

Alias
UMLS CUI [1]
C0201899
4. alanine aminotransferase (alt) (sgpt)< 2 times upper limit of normal
Description

alanine aminotransferase

Data type

boolean

Alias
UMLS CUI [1]
C0201836
5. alkaline phosphatase < 2 times upper limit of normal
Description

alkaline phosphatase

Data type

boolean

Alias
UMLS CUI [1]
C0201850
6. triglycerides < 150 mg/dl
Description

triglycerides

Data type

boolean

Alias
UMLS CUI [1]
C0202236
7. prothrombin time (pt) 11.7 -14.3 seconds
Description

prothrombin time

Data type

boolean

Alias
UMLS CUI [1]
C0491338
8. partial thromboplastin time 23.0-37.0 seconds
Description

partial thromboplastin time

Data type

boolean

Alias
UMLS CUI [1]
C3525810
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no diseases known to affect glucose metabolism other than healthy type 2 diabetes
Description

glucose metabolism; diabetes mellitus type 2

Data type

boolean

Alias
UMLS CUI [1]
C0596620
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0441730
subjects must not be receiving any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable dose of such agents for the past three months before entry into the study. subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months. subjects taking systemic glucocorticoids are excluded.
Description

Thiazide Diuretics; beta-blockers; estrogens therapy; systemic glucocorticoids

Data type

boolean

Alias
UMLS CUI [1]
C0012802
UMLS CUI [2]
C0001645
UMLS CUI [3]
C3541386
UMLS CUI [4]
C3540777
subjects with a history of clinically significant heart disease (new york heart classification greater than grade ii; more than non-specific st-t wave changes on the ekg), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied.
Description

heart disease; nyha classification; peripheral vascular disease; pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C1275491
UMLS CUI [3]
C0085096
UMLS CUI [4]
C0024115
recent systemic or pulmonary embolus, untreated high-risk proliferative retinopathy, recent retinal hemorrhage, uncontrolled hypertension, systolic bp>180, diastolic bp>105, autonomic neuropathy, resting heart rate >100, electrolyte abnormalities.
Description

Pulmonary Embolism; retinopathy; retinal hemorrhage; uncontrolled hypertension; blood pressure; neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0034065
UMLS CUI [2]
C0035309
UMLS CUI [3]
C0035317
UMLS CUI [4]
C1868885
UMLS CUI [5]
C0005823
UMLS CUI [6]
C0442874
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT01240252

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age 30-65 y
boolean
C0001779 (UMLS CUI [1])
diabetes mellitus type 2
Item
healthy lean, obese, or known type 2 diabetic
boolean
C0011849 (UMLS CUI [1,1])
C0441730 (UMLS CUI [1,2])
body mass index
Item
body mass index (bmi) less than 36
boolean
C1305855 (UMLS CUI [1])
Oral Glucose Tolerance Test
Item
all nondiabetic subjects must have normal oral glucose tolerance
boolean
C0029161 (UMLS CUI [1])
laboratory parameters
Item
subjects must have the following laboratory values:
boolean
C0022885 (UMLS CUI [1])
hematocrit
Item
1. hematocrit ≥ 35 vol%
boolean
C0518014 (UMLS CUI [1])
serum creatinine
Item
2. serum creatinine ≤ 1.6 mg/dl
boolean
C0201976 (UMLS CUI [1])
aspartate aminotransferase
Item
3. aspartate aminotransferase (ast) (sgot)< 2 times upper limit of normal
boolean
C0201899 (UMLS CUI [1])
alanine aminotransferase
Item
4. alanine aminotransferase (alt) (sgpt)< 2 times upper limit of normal
boolean
C0201836 (UMLS CUI [1])
alkaline phosphatase
Item
5. alkaline phosphatase < 2 times upper limit of normal
boolean
C0201850 (UMLS CUI [1])
triglycerides
Item
6. triglycerides < 150 mg/dl
boolean
C0202236 (UMLS CUI [1])
prothrombin time
Item
7. prothrombin time (pt) 11.7 -14.3 seconds
boolean
C0491338 (UMLS CUI [1])
partial thromboplastin time
Item
8. partial thromboplastin time 23.0-37.0 seconds
boolean
C3525810 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
glucose metabolism; diabetes mellitus type 2
Item
no diseases known to affect glucose metabolism other than healthy type 2 diabetes
boolean
C0596620 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0441730 (UMLS CUI [2,2])
Thiazide Diuretics; beta-blockers; estrogens therapy; systemic glucocorticoids
Item
subjects must not be receiving any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable dose of such agents for the past three months before entry into the study. subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months. subjects taking systemic glucocorticoids are excluded.
boolean
C0012802 (UMLS CUI [1])
C0001645 (UMLS CUI [2])
C3541386 (UMLS CUI [3])
C3540777 (UMLS CUI [4])
heart disease; nyha classification; peripheral vascular disease; pulmonary disease
Item
subjects with a history of clinically significant heart disease (new york heart classification greater than grade ii; more than non-specific st-t wave changes on the ekg), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied.
boolean
C0018799 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
C0085096 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
Pulmonary Embolism; retinopathy; retinal hemorrhage; uncontrolled hypertension; blood pressure; neuropathy
Item
recent systemic or pulmonary embolus, untreated high-risk proliferative retinopathy, recent retinal hemorrhage, uncontrolled hypertension, systolic bp>180, diastolic bp>105, autonomic neuropathy, resting heart rate >100, electrolyte abnormalities.
boolean
C0034065 (UMLS CUI [1])
C0035309 (UMLS CUI [2])
C0035317 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
C0005823 (UMLS CUI [5])
C0442874 (UMLS CUI [6])
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