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

Phase 4CompletedNCT02019186

Nationwide Children's Hospital9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

Vitamin CDIETARY_SUPPLEMENT

\<30 kg 250 mg 30-60 kg 500 mg \>60 kg 750 mg

Vitamin EDIETARY_SUPPLEMENT

\<30 kg 100 IU, 30-60 kg 200 IU, \>60 kg 300 IU

Eligibility

Sex: ALLMin age: 8 YearsMax age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Children and adolescent with T1D between 8 and 15 years of age will be studied. 2. Started on insulin therapy immediately after diagnosis. 3. Fasting c-peptide levels must be less than 0.4 ng/ml. 4. Hgb A1c levels greater than 8.3%. 5. 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. 6. Females on oral contraceptives will also be eligible to participate. Exclusion Criteria: 1. History oral hypoglycemic agent use. 2. BMI\>95th percentile 3. Hypertension 4. Elevated creatinine levels 5. Microalbuminuria.

Locations (1)

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

endothelial function

Endothelial function will be measured before and after 6 weeks of therapy with Vitamin C and E

Time frame: 6 weeks

Secondary Outcomes

Endothelial progenitor cells

Endothelial progenitor cells will be measured before and after 6 weeks of Vitamin C and E therapy

Time frame: 6 weeks

Data from ClinicalTrials.gov

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