Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes. (DIAB-01)

Anna Cruceta

Status and phase

Withdrawn

Phase 1

Conditions

Type 1 Diabetes Mellitus

Treatments

Drug: Vitamine C

Drug: Liraglutide 6 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02109315

DIAB-01

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.