Famine From Feast: Linking Vitamin C, Red Blood Cell Fragility, and Diabetes

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Apr 5, 2014

Keywords

ClinConnect Summary

This clinical trial, titled "Famine From Feast," is exploring how vitamin C levels in red blood cells (RBCs) may relate to diabetes type 2 and its complications. The researchers believe that low vitamin C levels in RBCs can lead to problems with blood flow, which is a common issue for people with diabetes. By studying how vitamin C works in the body, they hope to find ways to prevent serious health issues like blindness or kidney disease that can arise from diabetes.

To participate in this study, you should be between 18 and 65 years old, diagnosed with type 2 diabetes, and currently taking insulin or oral medications to manage your blood sugar. During the trial, you will spend time in the hospital for testing, where your vitamin C levels and blood flow will be monitored. You may also receive vitamin C and vitamin E supplements. The study aims to see how these supplements affect your RBCs and overall health. If you're considering joining, it's important to know that the risks of taking these vitamins are minimal, and you will be closely monitored throughout the trial.

Gender

ALL

Eligibility 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.