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

February 13, 2019 updated by: Anna Cruceta
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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Liraglutide endovenous 6 mg
Liraglutide endovenous de 0.6 mg. one time a day
Drug: Liraglutide 6 mg
Liraglutide endovenous de 0.6 mg. one time a day
EXPERIMENTAL: Vitamine C
C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min
Drug: Vitamine C
C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxidative stress markers
Time Frame: 8 weeks
Oxidative stress markers (nitrotyrosine and 8-iso prostaglandin F2 alpha plasma) in serum1 inflammation markers (serum sICAM-1, interleukin 6) 1
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Cruceta

Investigators

  • Principal Investigator: Antonio Ceriello A Ceriello, MD, Hospital Clinic i Provincial de Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ANTICIPATED)

May 1, 2015

Study Completion (ANTICIPATED)

May 1, 2015

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (ESTIMATE)

April 9, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIAB-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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