About this trial
Several studies have reported that diabetic subjects have lower plasma vitamin C concentrations than non-diabetic subjects. Although urinary vitamin C loss in diabetic subjects was reported to be increased in two studies, these are difficult to interpret due to lack of controlled vitamin C intake, inadequate sampling, lack of control subjects, or methodology uncertainties in vitamin C assay and sample processing. Consequently, it is unclear whether diabetic subjects truly have both low plasma and high urine vitamin C concentrations. We propose that low plasma vitamin C concentrations in diabetic subjects are due in part to inappropriate renal loss of vitamin C in these subjects but not in healthy controls. We will study nondiabetic controls and cohorts with diabetes. Vitamin C concentrations in plasma, RBCs, and urine will be measured in outpatients. In those willing to be admitted to the Clinical Center, we will measure vitamin C pharmacokinetics to determine the relative bioavailability for vitamin C in individuals with and without abnormal urinary loss of vitamin C (or renal leak). Single nucleotide polymorphisms (SNPs) will be determined in genomic DNA responsible for the two proteins mediating sodium dependent vitamin C transport, SVCT1 and SVCT2. We will also explore mechanisms underlying abnormal urinary vitamin C loss.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18-65 years.
Have no diagnosis of diabetes: "nondiabetic controls", or
Have a diagnosis in their medical history of either Type 1 or Type 2 diabetes
Disqualifiers
Unable or unwilling to provide a signed and dated informed consent form
Unable or unwilling to comply with study procedures and lifestyle considerations
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
Trial population
Community sample.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Plasma, neutrophil and RBC Vitamin C concentrates
Measurements of plasma, neutrophil and red blood cell vitamin c concentrations in diabetic subjects as compared to healthy controls.
Secondary outcomes
Urinary vitamin C concentration
Measurements of urinary vitamin c concentrations in diabetic subjects as compared to healthy controls.
Determine the renal threshold and relative bioavailability for vitamin C
Calculate renal threshold of vitamin C in diabetic subjects as compared to healthy controls.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.