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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vitamin C
Vitamin E
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring type 1 diabetes, endothelial function, adolescents, vitamin C, vitamin E

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Institute at Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin C and E

Arm Description

6 weeks of daily treatment with Vitamin C and E

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 18, 2013
Last Updated
February 2, 2015
Sponsor
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02019186
Brief Title
Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes
Official Title
Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
type 1 diabetes, endothelial function, adolescents, vitamin C, vitamin E

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin C and E
Arm Type
Experimental
Arm Description
6 weeks of daily treatment with Vitamin C and E
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Intervention Description
<30 kg 250 mg 30-60 kg 500 mg >60 kg 750 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin E
Intervention Description
<30 kg 100 IU, 30-60 kg 200 IU, >60 kg 300 IU
Primary Outcome Measure Information:
Title
endothelial function
Description
Endothelial function will be measured before and after 6 weeks of therapy with Vitamin C and E
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Endothelial progenitor cells
Description
Endothelial progenitor cells will be measured before and after 6 weeks of Vitamin C and E therapy
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: History oral hypoglycemic agent use. BMI>95th percentile Hypertension Elevated creatinine levels Microalbuminuria.
Facility Information:
Facility Name
Research Institute at Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22925199
Citation
Hoffman RP, Dye AS, Bauer JA. Ascorbic acid blocks hyperglycemic impairment of endothelial function in adolescents with type 1 diabetes. Pediatr Diabetes. 2012 Dec;13(8):607-10. doi: 10.1111/j.1399-5448.2012.00882.x. Epub 2012 Aug 28.
Results Reference
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PubMed Identifier
22701470
Citation
Dye AS, Huang H, Bauer JA, Hoffman RP. Hyperglycemia increases muscle blood flow and alters endothelial function in adolescents with type 1 diabetes. Exp Diabetes Res. 2012;2012:170380. doi: 10.1155/2012/170380. Epub 2012 Jun 3.
Results Reference
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PubMed Identifier
12505749
Citation
Varvarovska J, Racek J, Stozicky F, Soucek J, Trefil L, Pomahacova R. Parameters of oxidative stress in children with Type 1 diabetes mellitus and their relatives. J Diabetes Complications. 2003 Jan-Feb;17(1):7-10. doi: 10.1016/s1056-8727(01)00228-8.
Results Reference
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Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes

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