Linking Vitamin C and Red Blood Cell Function in Diabetes
Famine From Feast: Linking Vitamin C, Red Blood Cell Fragility, and Diabetes
This study is testing if giving vitamin C and vitamin E supplements can help improve blood flow and prevent complications in people with type 2 diabetes by looking at how vitamin C affects red blood cells.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (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 | NCT02107976 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the relationship between vitamin C levels in red blood cells and diabetes type 2, focusing on how these levels may affect microvascular health. The study aims to explore whether increasing vitamin C concentrations in red blood cells can improve their deformability and enhance blood flow in capillaries, potentially preventing complications associated with diabetes. Participants will receive vitamin C and vitamin E supplements while their red blood cell physiology is closely monitored. The research is essential to understand the role of vitamin C in diabetic patients and its potential therapeutic implications.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 with type 2 diabetes and specific hemoglobin A1C levels, as well as nondiabetic individuals without a history of diabetes.
Not a fit: Patients with type 1 diabetes or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for preventing serious complications in patients with diabetes type 2.
How similar studies have performed: While the specific approach of linking vitamin C in red blood cells to diabetes management is novel, related studies on vitamin C's role in vascular health have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: Stage 1 * Male or female 18-65 years old, able to give informed consent. * Diabetes type 2 HgA1C \<= 12% on insulin and/or oral hypoglycemic agents or nondiabetic without any prior history or diagnosis of diabetes. * In general good health with no other significant illness. * Mild concomitant disease such as mild hypothyroidism (TSH \<10) is acceptable. * Blood pressure with or without medication \<160/90 mmHg with no known significant target organ damage (end organ damage includes the following: proliferative retinopathy, serum creatinine \>1.5 or EGFR \< 55 mL/min, symptomatic ischemic heart disease, severe congestive heart failure, advanced peripheral vascular disease. * Willingness to use effective contraceptive methods such as barrier method for the duration of study (female subjects). Stage 2 Above criteria with addition of RBC vitamin C concentration \>30 uM prior to inpatient studies. EXCLUSION CRITERIA: Stage 1 and 2 * Diabetic type 1 subjects will be excluded due to the possibility of ketosis and hemodynamic instability with lack of insulin. * Any subjective or objective evidence of microangiopathy such as history of claudication, symptomatic peripheral vascular disease, symptomatic coronary artery disease, stroke, retinopathy, nephropathy (serum creatinine \>1.5 or EGFR \< 55 mL/min). * Diabetic subjects with retinopathy to avoid accelerated retinopathy with hyperglycemia. * Concomitant disease such as severe heart failure, severe liver disease (transaminases \> 3 times normal), or severe systemic disease of any sort. * Pregnancy, breastfeeding. * History of diabetic ketoacidosis or hyperosmolar coma. * Subjects with clear evidence of non-compliance with protocol/study instructions. * Subjects who are unwilling or lack capacity to provide informed consent.
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: Irene T Rozga, R.N.
- Email: irene.rozga@nih.gov
- Phone: (301) 496-1069
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.