Age
Item
men and women ≥ 20 years
boolean
C0001779 (UMLS CUI [1])
Blood pressure determination
Item
blood pressure less than 150/90. if on three separate clinic visits blood pressure remains above this level, a subject will be referred to his or her physician for treatment.
boolean
C0005824 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) ≥ 20 and ≤ 35 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Non-smoker | Use of Nicotine product Absent | Use of Recreational Drugs Absent
Item
non-smoking and does not use nicotine products or recreational drugs.
boolean
C0337672 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C0028040 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1524063 (UMLS CUI [3,1])
C0242508 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Alcohol consumption Absent | Dietary Supplements Absent
Item
agrees to consume no alcohol or dietary supplements during the study.
boolean
C0001948 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0242295 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Serum total cholesterol measurement Percentile | Gender | Age | Serum LDL cholesterol measurement Percentile
Item
total cholesterol and ldl cholesterol <95th percentile for sex and age.
boolean
C1445957 (UMLS CUI [1,1])
C1264641 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0428474 (UMLS CUI [4,1])
C1264641 (UMLS CUI [4,2])
Serum fasting triglyceride measurement
Item
fasting triglycerides <500mg/dl.
boolean
C0582824 (UMLS CUI [1])
Homeostasis model assessment Insulin Resistance Measurement Percentile | Gender
Item
homa-ir ≥ 50th percentile for sex.
boolean
C1829779 (UMLS CUI [1,1])
C4049994 (UMLS CUI [1,2])
C1264641 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
Fasting Blood Sugar Measurement
Item
fasting blood sugar (fbs) < 126 mg/dl.
boolean
C2825162 (UMLS CUI [1])
Hematocrit level
Item
hematocrit ≥ 36%.
boolean
C0518014 (UMLS CUI [1])
Stable body weight Duration | Body Weight Maintenance Required
Item
at least 3 months of a weight stable state. during the study, subjects will be required to maintain their body weight within ± 3% (up to a maximum change of 5 lbs) of their initial weight over the course of any consecutive two weeks.
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C4042910 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Childbearing Potential Barrier Contraception Quantity | Childbearing Potential Urine HCG Test | Childbearing Potential Urine pregnancy test
Item
for women of childbearing potential, two barrier methods of contraception must be used throughout the study and urine pregnancy b-hcg will be done at screen (v1) and at all "a" visits (v2a, 3a, 4a). subjects who become pregnant will no longer be allowed to continue the study.
boolean
C3831118 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0236449 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430056 (UMLS CUI [3,2])
Postmenopausal state | Elevated plasma FSH Consistent with Postmenopausal state
Item
women will be considered post-menopausal if ≥ 3 years since last menses or no menses for 1-3 years and plasma fsh elevated into postmenopausal range.
boolean
C0232970 (UMLS CUI [1])
C1848191 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0232970 (UMLS CUI [2,3])
Exclusion Criteria | Protocol Compliance Unsuccessful | Blood draw Unsuccessful | Compliance behavior Lacking
Item
subjects who cannot complete the requirements of the study for reasons determined by the investigator (i.e. non-accessible veins for blood drawing, inability to keep clinic appointments) will not be able to participate in the study.
boolean
C0680251 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0005834 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
C1321605 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Coronary heart disease | Cerebrovascular Disorders | Peripheral Vascular Diseases | Blood Coagulation Disorders | Liver diseases | Kidney Diseases | Diabetes Mellitus | Lung diseases | HIV Infections | Malignant Neoplasms | Exception Skin carcinoma
Item
history of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, hiv, or cancer (other than skin cancer) in the last 5 years.
boolean
C0010068 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
C0085096 (UMLS CUI [3])
C0005779 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0011849 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0019693 (UMLS CUI [9])
C0006826 (UMLS CUI [10])
C1705847 (UMLS CUI [11,1])
C0699893 (UMLS CUI [11,2])
Pharmaceutical Preparations Affecting Lipid Metabolism | Anticoagulants | Hormones
Item
taking drugs known to affect lipid metabolism, blood thinning agents or hormones
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0598783 (UMLS CUI [1,3])
C0003280 (UMLS CUI [2])
C0019932 (UMLS CUI [3])
Abnormal thyroid-stimulating hormone level
Item
abnormal thyroid stimulating hormone (tsh) levels
boolean
C4476968 (UMLS CUI [1])