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

NCT02109315 | Withdrawn Phase 1

• 1 other identifier: DIAB-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery.

  8 weeks

Secondary Outcomes (1)

• Oxidative stress markers

  8 weeks

Study Arms (2)

Liraglutide endovenous 6 mg

EXPERIMENTAL

Liraglutide endovenous de 0.6 mg. one time a day

Drug: Liraglutide 6 mg

Vitamine C

EXPERIMENTAL

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

Drug: Vitamine C

Interventions

Vitamine C DRUG

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

Vitamine C

Liraglutide 6 mg DRUG

Liraglutide endovenous de 0.6 mg. one time a day

Liraglutide endovenous 6 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anna Cruceta: lead

Study Sites (1)

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Antonio Ceriello A Ceriello, MD

  Hospital clínic i provincial de Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 9, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 15, 2019

Record last verified: 2014-04

Locations

ES (1)