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

• Status: Withdrawn
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anna Cruceta
• Treatments: Ascorbic Acid; Liraglutide; Vitamins

Criteria

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.