Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery.
研究概览
简要总结
To investigate the effect of liraglutide on vascular injury induced hypoglycemia in patients with type 1 diabetes mellitus. The vascular damage is evaluated at investigating the changes of endothelial function
详细描述
To investigate the effect of antioxidants (Vitamin C) on the vascular damage induced hypoglycemia in patients with type 1 diabetes. The vascular injury was evaluated in the same way as main objective. Checking the existence of a peripheral response to the action of GLP-1 due to oxidative stress.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed and signed consent obtained before any trial-related activity . ( Trial-related activities are those procedures that were not performed during routine medical examination of the patient) .
- •Diagnosis of type 1 diabetes.
- •Patients who do not have autonomic dysfunction , defined by ( 1).
- •Patients not showing episodes of hypoglycemia unawareness based on the methods of Gold et al (2) .
- •Patients without microvascular complications of diabetes.
- •Patients without macrovascular complications of diabetes.
- •Patients treated with multiple daily injections of insulin.
- •No smoking .
- •They should have a complete blood count, lipid profile, liver profile , renal profile and plasma electrolyte levels within normal values .
- •No subject must have a history of hypertension or taking medication for high blood pressure .
- •No subject should be taking medications known to affect the neuroendocrine responses to hypoglycemia or anti inflammatory
排除标准
- •Known or suspected hypersensitivity to study some related products.
- •Fertile women, lactating or pregnant, intend to become pregnant or who are not using adequate contraception, or men who have sexually active and are not sterilized surgically, those whose partners are not using a method adequate contraception.
- •Clinical diagnosis of Type 2 Diabetes.
研究组 & 干预措施
Liraglutide endovenous 6 mg
Liraglutide endovenous de 0.6 mg. one time a day
干预措施: Liraglutide 6 mg (Drug)
Vitamine C
C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min
干预措施: Vitamine C (Drug)
结局指标
主要结局
Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery.
时间窗: 8 weeks
次要结局
- Oxidative stress markers(8 weeks)
研究者
Anna Cruceta
Project manager
Fundacion Clinic per a la Recerca Biomédica