Efficacy of Coenzyme Q10 Supplementation on Metabolic Control in Children With Type 1 Diabetes Mellitus: a Randomized Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus
研究概览
简要总结
Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin
详细描述
Type 1 diabetes mellitus is an autoimmune disease that leads to destruction of insulin producing pancreatic Beta cells.
Individuals with type 1 diabetes requires life long insulin replacement with multiple daily insulin injection. daily,insulin pump therapy or the use of an automated insulin delivery system.
without insulin ,diabetic ketoacidosis develops and is life threatening.
In addition to insulin Therapy ,glucose monitoring with a continuous glucose monitor and a blood glucose monitor if continuous glucose monitor is unavailable is recommended .
Coenzyme Q10 supplementation has beneficial effects on glycemic control especially in diabetes , and 100-200 mg per day of Co Q10 could achieve the greatest benefit which could provide a basis for the dietary guidelines of Co Q10 in patients with glycemic disorders .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed as type 1 diabetes mellitus from age of 2 years old to 18 years old with diabetes mellitus of duration at least 1 year.
排除标准
- •- patients diagnosed as diabetes mellitus less than 2 years old .
- •patients with diabetes mellitus of duration less than 1 year.
- •patients diagnosed as type 1 diabetes mellitus with Thyroid or celiac diseases.
- •other types of hyperglycemia rather than Type 1 diabetes mellitus.
研究组 & 干预措施
Group A
Will take Coenzyme Q10 soft gel capsules or tablets in a dose of 100-200mg of natural factors
干预措施: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets (Drug)
Group B
Will not take Coenzyme Q10 soft gel capsules or tablets
干预措施: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets (Drug)
结局指标
主要结局
Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus
时间窗: One year
This prospective randomized clinical trial will be conducted on 100 participants . Half of them will not receive treatment but group A will receive 100-200mg of Coenzyme Q10 . the level of glycated hemoglobin, fasting blood glucose will be assessed for both groups at baseline and after 3 months of treatment for ongoing use in diabetic children
次要结局
- Control of random blood sugar and glycated haemoglobin in children with type 1 diabetes mellitus .(One year)
研究者
Christina Saad Abdel Malak Abdel Nour
Principal Investigator
Assiut University