Type 1 Diabetes Mellitus
Conditions
Brief summary
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
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.
Interventions
DRUGVitamine C
C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min
DRUGLiraglutide 6 mg
Liraglutide endovenous de 0.6 mg. one time a day
Sponsors
Anna Cruceta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery. | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative stress markers | 8 weeks | Oxidative stress markers (nitrotyrosine and 8-iso prostaglandin F2 alpha plasma) in serum1 inflammation markers (serum sICAM-1, interleukin 6) 1 |
Countries
Spain
Outcome results
None listed