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

NCT ID: NCT02109315

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-05-31

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liraglutide endovenous 6 mg

Liraglutide endovenous de 0.6 mg. one time a day

Group Type: EXPERIMENTAL

Liraglutide 6 mg

Intervention Type: DRUG

Liraglutide endovenous de 0.6 mg. one time a day

Vitamine C

C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min

Group Type: EXPERIMENTAL

Vitamine C

Intervention Type: DRUG

C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min

Interventions

Vitamine C

C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min

Intervention Type: DRUG

Liraglutide 6 mg

Liraglutide endovenous de 0.6 mg. one time a day

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anna Cruceta

OTHER

Sponsor Role: lead

Responsible Party

Anna Cruceta

Project manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Antonio Ceriello A Ceriello, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital clínic i provincial de Barcelona

Locations

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Countries

Spain

Other Identifiers

DIAB-01

Identifier Type: -

Identifier Source: org_study_id