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Urinary Vitamin C Loss in Diabetic Subjects

Urinary Vitamin C Loss in Subjects With and Without Diabetes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00071526
Enrollment
5000
Registered
2003-10-28
Start date
2006-04-11
Completion date
Unknown
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Renal Threshold, Diabetes Mellitus, Proteinuria, Plasma Concentrations, Healthy Volunteer

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* INCLUSION CRITERIA: To be included in the study, study subjects should be: * Aged 18-65 years. * Either: * Have no diagnosis of diabetes: "nondiabetic controls", or * Have a diagnosis in their medical history of either Type 1 or Type 2 diabetes

Exclusion criteria

(for outpatient study, arm 1)

Design outcomes

Primary

MeasureTime frameDescription
Plasma, neutrophil and RBC Vitamin C concentratesend of studyMeasurements of plasma, neutrophil and red blood cell vitamin c concentrations in diabetic subjects as compared to healthy controls.

Secondary

MeasureTime frameDescription
Urinary vitamin C concentrationend of studyMeasurements of urinary vitamin c concentrations in diabetic subjects as compared to healthy controls.
Determine the renal threshold and relative bioavailability for vitamin Cend of studyCalculate renal threshold of vitamin C in diabetic subjects as compared to healthy controls.

Countries

United States

Contacts

CONTACTRazi S Berman, C.R.N.P.
razi.berman@nih.gov(301) 827-5757
CONTACTIfechukwude C Ebenuwa, M.D.
ifechukwude.ebenuwa@nih.gov(301) 435-6582
PRINCIPAL_INVESTIGATORIfechukwude C Ebenuwa, M.D.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026