Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes

Completed · Phase 4

Conditions studied: Type 1 Diabetes Mellitus

In brief

The endothelium is the lining of the blood vessels that helps prevent damage to the vessels. The endothelium does not function as well as it should in adolescents with type 1 diabetes. This causes future diabetes complications. Adolescents with diabetes also have abnormalities of the cells that repair the endothelium. These abnormalities may be due to damage caused by intermittent hyperglycemia. This studied is designed to study whether low dose, combined Vitamin C and E supplementation improves endothelial function and repair in adolescents with type 1 diabetes.

Key facts

Study ID

NCT02019186

Run by

Nationwide Children's Hospital

People needed

9

Starts

2013-12-01

Expected to finish

2015-01-01

Last updated by the study team

2015-02-03

Who can join

Age: 8 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children and adolescent with T1D between 8 and 15 years of age will be studied.
• Started on insulin therapy immediately after diagnosis.
• Fasting c-peptide levels must be less than 0.4 ng/ml.
• Hgb A1c levels greater than 8.3%.
• All subjects must be in good health other than having diabetes. Subjects with hypothyroidism will be allowed assuming they are on stable thyroxine replacement and have normal thyroid function tests.
• Females on oral contraceptives will also be eligible to participate.

You may not qualify if…

• History oral hypoglycemic agent use.
• BMI>95th percentile
• Hypertension
• Elevated creatinine levels
• Microalbuminuria.

Where it is running

• Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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