Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- endothelial function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •History oral hypoglycemic agent use.
- •BMI>95th percentile
- •Hypertension
- •Elevated creatinine levels
- •Microalbuminuria.
研究组 & 干预措施
Vitamin C and E
6 weeks of daily treatment with Vitamin C and E
干预措施: Vitamin E (Dietary Supplement)
Vitamin C and E
6 weeks of daily treatment with Vitamin C and E
干预措施: Vitamin C (Dietary Supplement)
结局指标
主要结局
endothelial function
时间窗: 6 weeks
Endothelial function will be measured before and after 6 weeks of therapy with Vitamin C and E
次要结局
- Endothelial progenitor cells(6 weeks)
研究者
Robert Hoffman
Professor
Nationwide Children's Hospital