Age | Healthy Volunteers | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
we propose to study an unlimited number of male and female subjects between the ages of 18 and 65. this will include healthy subjects and subjects with type 1 or type 2 diabetes. to be included in the study, study subjects should
boolean
C0001779 (UMLS CUI [1])
C1708335 (UMLS CUI [2])
C0011854 (UMLS CUI [3])
C0011860 (UMLS CUI [4])
General health good
Item
be in good general health
boolean
C1277245 (UMLS CUI [1])
Illness Significant compromises Stable status Clinical | Complications of Diabetes Mellitus | Metabolic Syndrome | Myocardial Ischemia | Peripheral Arterial Diseases
Item
have no significant illnesses that compromise clinical stability other than the complications of diabetes mellitus alone or in the context of metabolic syndrome. subjects with ischemic heart disease and/or peripheral artery disease are eligible for arm 1 of the protocol.
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0205210 (UMLS CUI [1,5])
C0342257 (UMLS CUI [2])
C0524620 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
C1704436 (UMLS CUI [5])
Creatinine measurement, serum
Item
have serum creatinine < 2.5
boolean
C0201976 (UMLS CUI [1])
Healthy Volunteers normotensive | Blood Pressure
Item
for healthy volunteers, be normotensive at the time of the study, with a blood pressure less than or equal to 140/90
boolean
C1708335 (UMLS CUI [1,1])
C2712122 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2])
Study Subject Diabetic | Blood Pressure | Stable status Clinical | health Usual | Chest Pain | Dyspnea | Headache | Syncope | Fatigue
Item
for diabetic subjects, blood pressure less than or equal to 170/95 as long as clinically stable and in usual state of health, for example, no chest pain, shortness of breath, headache, syncope or fatigue
boolean
C0681850 (UMLS CUI [1,1])
C0241863 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2])
C0205360 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0683314 (UMLS CUI [4,1])
C3538928 (UMLS CUI [4,2])
C0008031 (UMLS CUI [5])
C0013404 (UMLS CUI [6])
C0018681 (UMLS CUI [7])
C0039070 (UMLS CUI [8])
C0015672 (UMLS CUI [9])
Study Subject Diabetic | Condition Clinical Normal | Urine vitamin C measurement | Hyperglycemia Uncontrolled
Item
the aim of this study is to determine whether diabetic subjects lose vitamin c in the urine in their normal clinical condition (i.e. while on treatment) and not in the native untreated state of uncontrolled hyperglycemia. therefore the patients will not discontinue medication.
boolean
C0681850 (UMLS CUI [1,1])
C0241863 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
C1278265 (UMLS CUI [3])
C0020456 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Exclusion Criteria Protocol Treatment Arm
Item
exclusion criteria (for arm 1):
boolean
C0680251 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
ID.9
Item
exclusion criteria will include the following:
boolean
Organ failure Significant Causing Instability Clinical | Liver diseases | Lung diseases | Cerebrovascular accident | Anemia
Item
significant organ malfunction leading to clinical instability including liver disease, pulmonary disease, stroke and anemia at investigator discretion
boolean
C0231174 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C1444783 (UMLS CUI [1,4])
C0205210 (UMLS CUI [1,5])
C0023895 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0002871 (UMLS CUI [5])
Illness Serious Causing Instability Clinical | Chronic disease Causing Instability Clinical | Complications of Diabetes Mellitus
Item
serious or chronic illness or history of serious or chronic illness resulting in clinical instability other than complications of diabetes
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C1444783 (UMLS CUI [1,4])
C0205210 (UMLS CUI [1,5])
C0008679 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C1444783 (UMLS CUI [2,3])
C0205210 (UMLS CUI [2,4])
C0342257 (UMLS CUI [3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Alcohol abuse | Drug Dependence | Illicit drug use
Item
alcohol abuse, drug addiction or the use of illegal drugs
boolean
C0085762 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
C0281875 (UMLS CUI [3])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
positive hiv or hepatitis (b or c) screening tests (subjects will be notified of these test results).
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Comorbidity Affecting Vitamin C metabolism | Comorbidity Affecting Vitamin C Kidney Handling
Item
presence of other concomitant conditions which in the judgment of the investigators can influence vitamin c metabolism or vitamin c renal handling
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1158854 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0003968 (UMLS CUI [2,3])
C0022646 (UMLS CUI [2,4])
C1832073 (UMLS CUI [2,5])
Exclusion Criteria Protocol Treatment Arm
Item
exclusion criteria (for arms 2 and 3):
boolean
C0680251 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
ID.17
Item
exclusion criteria will include the following:
boolean
Organ failure Significant Causing Instability Clinical | Liver diseases | Lung diseases | Myocardial Ischemia | Heart failure | Cerebrovascular accident | Peripheral Vascular Diseases | Anemia
Item
significant organ malfunction leading to clinical instability including liver disease, pulmonary disease, ischemic heart disease, heart failure, stroke, peripheral vascular disease, and anemia at investigator discretion
boolean
C0231174 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C1444783 (UMLS CUI [1,4])
C0205210 (UMLS CUI [1,5])
C0023895 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
C0018801 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0085096 (UMLS CUI [7])
C0002871 (UMLS CUI [8])
Illness Serious | Chronic disease | Coronary Artery Disease Causing Instability Clinical | Peripheral Vascular Diseases Causing Instability Clinical
Item
other serious or chronic illness; history of serious or chronic illness; coronary artery disease, or peripheral vascular disease resulting in clinical instability
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
C1956346 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C1444783 (UMLS CUI [3,3])
C0205210 (UMLS CUI [3,4])
C0085096 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C1444783 (UMLS CUI [4,3])
C0205210 (UMLS CUI [4,4])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Alcohol abuse | Drug Dependence | Illicit drug use
Item
alcohol abuse, drug addiction or the use of illegal drugs
boolean
C0085762 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
C0281875 (UMLS CUI [3])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
positive hiv or hepatitis (b or c) screening tests (subjects will be notified of these test results).
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Comorbidity Affecting Vitamin C metabolism | Comorbidity Affecting Vitamin C Kidney Handling
Item
presence of other concomitant conditions which in the judgment of the investigators can influence vitamin c metabolism or vitamin c renal handling
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1158854 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0003968 (UMLS CUI [2,3])
C0022646 (UMLS CUI [2,4])
C1832073 (UMLS CUI [2,5])
Exclusion Criteria Inpatient | Food Consumption During Hospitalization | Drinking Beverages During Hospitalization | Diet Vitamin C Free of
Item
for inpatient subjects, an additional exclusion criterion is consumption during the hospitalization of any foods or beverages other than those in the vitamin c free diet.
boolean
C0680251 (UMLS CUI [1,1])
C0021562 (UMLS CUI [1,2])
C2983605 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0019993 (UMLS CUI [2,3])
C0684271 (UMLS CUI [3,1])
C0005329 (UMLS CUI [3,2])
C0347984 (UMLS CUI [3,3])
C0019993 (UMLS CUI [3,4])
C0012155 (UMLS CUI [4,1])
C0003968 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])