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

Phase 4

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin E

• Registration Number: NCT02019186
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-24
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin C and E	Vitamin E	6 weeks of daily treatment with Vitamin C and E
Vitamin C and E	Vitamin C	6 weeks of daily treatment with Vitamin C and E

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Institute at Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States