The Possible Role of Alpha-Lipoic Acid in Improving Endothelial Dysfunction and Atherosclerosis in Children With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- The change in carotid artery intima-media thickness (CIMT)
研究概览
简要总结
This study aims at investigating the possible effect of alpha-lipoic acid on endothelial dysfunction and atherosclerosis in children with type 1 diabetes mellitus.
详细描述
Endothelial dysfunction and alterations in vascular structure are early indicators of future cardiovascular events. The atherosclerotic changes begin much earlier than the appearance of clinical disease. Endothelial dysfunction in diabetes may be the result of a combination of multiple stressors. In the patients with type 1 diabetes, a significant increase in the concentrations of endothelial markers was already observed at the early stages of the disease including vascular cell adhesion molecules (VCAM-1), intercellular adhesion molecules (sICAM-1), soluble E- selectin E (sE-Selektin), asymmetric dimethylarginine (ADMA), plasminogen activator inhibitor 1 (PAI-1) because their concentrations increase rapidly in states of cellular stress. Increased carotid intima-media thickness (CIMT) is a structural marker for early atherosclerosis that correlates with cardio-vascular risk factors.
Alpha -lipoic acid supplementation may have role in Improving Endothelial Dysfunction and early Atherosclerosis due to its oxidative and anti-inflammatory effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with T1DM on insulin therapy ≥ 0.5 IU/kg/day.
- •Age range between 12 and < 18 years old.
- •Both sex.
- •Duration of diabetes ≥ 3 years.
- •Glycated hemoglobin of ≥ 7.5%
- •Patients who are previously evaluated for endothelial dysfunction and atherosclerosis.
排除标准
- •Clinical evidence of heart failure, coronary artery disease, systemic hypertension, rheumatic fever, cardiomyopathy.
- •Concurrent use of any medication other than insulin known to affect cardiac function (such as digitalis, angiotensin converting enzyme inhibitor, or β-blocker, etc...).
- •Concurrent use of hyperlipidemia agents (Statin, fibrate).
- •Concurrent use of antioxidants as selenium, vitamin C, vitamin E, etc..
- •Patients with inflammatory conditions.
- •Patients with conditions predispose to oxidative stress (obesity, COPD, etc...).
- •Patients with liver disease.
- •Patients with thyroid disease.
- •Patients with seizures.
研究组 & 干预措施
Placebo group who received insulin only plus placebo tablets
(Placebo group; n=22) which will receive insulin plus placebo tablets once daily for 6 months.
干预措施: Placebo (Other)
ALA group who received Alpha lipoic acid plus insulin
(alpha-lipoic acid group; n=22) which will receive insulin plus ALA 600mg once daily for 6 months.
干预措施: Alpha Lipoic Acid 600 MG Oral Capsule (Drug)
结局指标
主要结局
The change in carotid artery intima-media thickness (CIMT)
时间窗: Baseline and 6 months
Measurement of carotid intima-media thickness (CIMT) which is mainly used to assess subclinical atherosclerosias and its assessment is based on ultrasound transducer
次要结局
- The change in serum level (MDA)(Baseline and 6 months)
- The change in serum level of hs-CRP(Baseline and 6 months)
- The change in the serum level of Apelin(Baseline and 6 months)
- Fast blood glucose measuremt(Baseline and 6 months)
- The change in the serum level of VCAM-1(Baseline and 6 months)
- Change in plasma level of (HbA1c %)(Baseline and 3,6 months)
- Lipid profile measuremt(Baseline and 6 months)
研究者
Sara Ahmed mohamed Attia Harby
Administrator at faculty of pharmacy, Tanta university
Tanta University