Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes.

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes.

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: Vitamine C
* Drug: Liraglutide 6 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide endovenous 6 mg<br>Liraglutide endovenous de 0.6 mg. one time a day | Drug: Liraglutide 6 mg<br>* Liraglutide endovenous de 0.6 mg. one time a day<br>|
| Experimental: Vitamine C<br>C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min | Drug: Vitamine C<br>* C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress markers | Oxidative stress markers (nitrotyrosine and 8-iso prostaglandin F2 alpha plasma) in serum1 inflammation markers (serum sICAM-1, interleukin 6) 1 | 8 weeks |