RECRUITING

Urinary Vitamin C Loss in Diabetic Subjects

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Urinary Vitamin C Loss in Subjects With and Without Diabetes

Quick Facts

Study Start:2006-04-11
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00071526

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18-65 years.
  2. * Either:
  3. * Have no diagnosis of diabetes: "nondiabetic controls", or
  4. * Have a diagnosis in their medical history of either Type 1 or Type 2 diabetes
  5. * Unable or unwilling to provide a signed and dated informed consent form
  6. * Unable or unwilling to comply with study procedures and lifestyle considerations
  7. * 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
  8. * other serious or chronic illness; history of serious or chronic illness; coronary artery disease, or peripheral vascular disease resulting in clinical instability
  9. * pregnancy or lactation
  10. * presence of other conditions which, in the judgment of the investigators, can influence vitamin C metabolism or vitamin C renal handling
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

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

Principal Investigator

Ifechukwude C Ebenuwa, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

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

  • Ifechukwude C Ebenuwa, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2006-04-11
Study Completion DateN/A

Study Record Updates

Study Start Date2006-04-11
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Diabetes