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

Type 1 Diabetes Mellitus Clinical Trial

— DIAB-01  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02109315
• Other study ID #: DIAB-01
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: April 2014
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Inflammation
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Vitamine C
C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min
• Liraglutide 6 mg
Liraglutide endovenous de 0.6 mg. one time a day

Locations

Country	Name	City	State
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Anna Cruceta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery.		8 weeks
Secondary	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