Investigating Vitamin C Loss in Diabetic Patients
Urinary Vitamin C Loss in Subjects With and Without Diabetes
This study tests if people with diabetes have lower vitamin C levels in their blood and higher amounts in their urine compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00071526 on ClinicalTrials.gov |
What this trial studies
This study examines the relationship between vitamin C levels in plasma and urine among diabetic individuals compared to healthy controls. It aims to clarify whether diabetic patients experience both low plasma vitamin C concentrations and increased urinary loss. Participants will have their vitamin C levels measured in various biological samples, and those who consent will undergo further testing to assess vitamin C pharmacokinetics. The study also seeks to identify genetic factors that may influence vitamin C transport in the body.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 with either Type 1 or Type 2 diabetes or healthy individuals without diabetes.
Not a fit: Patients with significant organ malfunction or serious chronic illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to better understanding and management of vitamin C levels in diabetic patients, potentially improving their overall health.
How similar studies have performed: While some studies have suggested similar findings, this research aims to provide more controlled and comprehensive insights into vitamin C metabolism in diabetic patients.
Eligibility criteria
Show full inclusion / exclusion 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) Exclusion criteria will include the following: * Unable or unwilling to provide a signed and dated informed consent form * Unable or unwilling to comply with study procedures and lifestyle considerations EXCLUSION CRITERIA (for inpatient studies, arms 2 and 3) Study participants interested in participating in Arms 2 and/or 3 will be excluded from this further participation if they meet any of 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 or lactation * presence of other conditions which, in the judgment of the investigators, can influence vitamin C metabolism or vitamin C renal handling
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Ifechukwude C Ebenuwa, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Razi S Berman, C.R.N.P.
- Email: razi.berman@nih.gov
- Phone: (301) 827-5757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.