Age | Informed Consent
Item
male or female 18-60 years old, able to give informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Insulin | Hypoglycemic Agents Oral
Item
diabetes type 2 hga1c 7-12 percent on insulin and/or oral hypoglycemic agents.
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0021641 (UMLS CUI [3])
C0020616 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
General health good | Illness Other Absent
Item
in general good health with no other significant illness.
boolean
C1277245 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Comorbidity Mild Acceptable | Hypothyroidism Mild | Thyroid stimulating hormone measurement
Item
mild concomitant disease such as mild hypothyroidism (tsh < 10) is acceptable.
boolean
C0009488 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
C0020676 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0202230 (UMLS CUI [3])
Blood pressure determination | Relationship Pharmaceutical Preparations | Independent of Pharmaceutical Preparations | Target Organ Damage Absent | Proliferative retinopathy | Creatinine measurement, serum | Estimated Glomerular Filtration Rate | Myocardial Ischemia Symptomatic | Congestive heart failure Severe | Peripheral Vascular Disease Advanced
Item
blood pressure with or without medication < 160/90 mmhg with no known significant target organ damage (end organ damage includes the following: proliferative retinopathy, serum creatinine > 1.5 or egfr < 55 ml/min, symptomatic ischemic heart disease, severe congestive heart failure, advanced peripheral vascular disease.
boolean
C0005824 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0332291 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C1521840 (UMLS CUI [4,1])
C0178784 (UMLS CUI [4,2])
C1883709 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
C0339467 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C3811844 (UMLS CUI [7])
C0151744 (UMLS CUI [8,1])
C0231220 (UMLS CUI [8,2])
C0018802 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0085096 (UMLS CUI [10,1])
C0205179 (UMLS CUI [10,2])
Plasma Vitamin C level | Erythrocytes Vitamin C level
Item
plasma/rbc vitamin c levels less than or equal to 30 microm.
boolean
C0032105 (UMLS CUI [1,1])
C0201898 (UMLS CUI [1,2])
C0014792 (UMLS CUI [2,1])
C0201898 (UMLS CUI [2,2])
Gender Contraceptive methods | Contraception, Barrier
Item
willingness to use effective contraceptive methods such as barrier method for the duration of study (female subjects).
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent | At risk Ketosis | At risk Hemodynamic instability
Item
diabetic type 1 subjects will be excluded due to the possibility of ketosis and hemodynamic instability with lack of insulin.
boolean
C0011854 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0022638 (UMLS CUI [2,2])
C1444641 (UMLS CUI [3,1])
C0948268 (UMLS CUI [3,2])
Microangiopathy | Claudication | Peripheral Vascular Diseases Symptomatic | Coronary Artery Disease Symptomatic | Cerebrovascular accident | Retinal Diseases | Kidney Diseases | Creatinine measurement, serum | Estimated Glomerular Filtration Rate
Item
any subjective or objective evidence of microangiopathy such as history of claudication, symptomatic peripheral vascular disease, symptomatic coronary artery disease, stroke, retinopathy, nephropathy (serum creatinine > 1.5 or egfr < 55 ml/min).
boolean
C0155765 (UMLS CUI [1])
C1456822 (UMLS CUI [2])
C0085096 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C1956346 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0038454 (UMLS CUI [5])
C0035309 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C3811844 (UMLS CUI [9])
Retinal Disease
Item
subjects with retinopathy to avoid accelerated retinopathy with hyperglycemia.
boolean
C0035309 (UMLS CUI [1])
Comorbidity | Heart failure Severe | Liver disease Severe | Transaminases increased | Systemic disease Severe
Item
concomitant disease such as severe heart failure, severe liver disease (transaminases > 3 times normal), or severe systemic disease of any sort.
boolean
C0009488 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0438717 (UMLS CUI [4])
C0442893 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Study Subject Participation Status | Consideration Patient safety
Item
participation in each protocol delineated evaluation procedure will be judged on a case by case basis with patient safety as the paramount consideration.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1113679 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnancy, breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetic Ketoacidosis | Hyperosmolar Coma
Item
history of diabetic ketoacidosis or hyperosmolar coma.
boolean
C0011880 (UMLS CUI [1])
C0020457 (UMLS CUI [2])