This study is currently recruiting participants.
Number
04-DK-0021
Sponsoring Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 65 Years
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Renal Threshold; Diabetes Mellitus; Proteinuria; Plasma Concentrations; Healthy Volunteer
Recruitment Keyword(s)
None
Condition(s)
Diabetes
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Diabetes and Digestive and Kidney Diseases
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INCLUSION CRITERIA: We propose to study of five thousand 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 -be in good general health -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. -have serum creatinine < 2.5 -for healthy volunteers, be normotensive at the time of the study, with a blood pressure less than or equal to 140/90 -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 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. EXCLUSION CRITERIA (for arm 1): Exclusion criteria will include the following: --significant organ malfunction leading to clinical instability including liver disease, pulmonary disease, stroke and anemia at investigator discretion --serious or chronic illness or history of serious or chronic illness resulting in clinical instability other than complications of diabetes --pregnancy --alcohol abuse, drug addiction or the use of illegal drugs --positive HIV or hepatitis (B or C) screening tests (subjects will be notified of these test results). --presence of other concomitant conditions which in the judgment of the investigators can influence vitamin C metabolism or vitamin C renal handling EXCLUSION CRITERIA (for arms 2 and 3): Exclusion criteria will include the following: -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 -other serious or chronic illness; history of serious or chronic illness; coronary artery disease, or peripheral vascular disease resulting in clinical instability -pregnancy -alcohol abuse, drug addiction or the use of illegal drugs -positive HIV or hepatitis (B or C) screening tests (subjects will be notified of these test results). -presence of other concomitant conditions which in the judgment of the investigators can influence vitamin C metabolism or vitamin C renal handling 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.
We propose to study of five thousand 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
-be in good general health
-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.
-have serum creatinine < 2.5
-for healthy volunteers, be normotensive at the time of the study, with a blood pressure less than or equal to 140/90
-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
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.
EXCLUSION CRITERIA (for arm 1):
Exclusion criteria will include the following:
--significant organ malfunction leading to clinical instability including liver disease, pulmonary disease, stroke and anemia at investigator discretion
--serious or chronic illness or history of serious or chronic illness resulting in clinical instability other than complications of diabetes
--pregnancy
--alcohol abuse, drug addiction or the use of illegal drugs
--positive HIV or hepatitis (B or C) screening tests (subjects will be notified of these test results).
--presence of other concomitant conditions which in the judgment of the investigators can influence vitamin C metabolism or vitamin C renal handling
EXCLUSION CRITERIA (for arms 2 and 3):
-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
-other serious or chronic illness; history of serious or chronic illness; coronary artery disease, or peripheral vascular disease resulting in clinical instability
-pregnancy
-alcohol abuse, drug addiction or the use of illegal drugs
-positive HIV or hepatitis (B or C) screening tests (subjects will be notified of these test results).
-presence of other concomitant conditions which in the judgment of the investigators can influence vitamin C metabolism or vitamin C renal handling
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.
Principal Investigator
Referral Contact
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