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

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ClinicalTrials.gov Identifier: NCT02109315
Recruitment Status : Withdrawn
First Posted : April 9, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Vitamine C Drug: Liraglutide 6 mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes.
Study Start Date : May 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015


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




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

Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109315


Locations
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Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Anna Cruceta
Investigators
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Principal Investigator: Antonio Ceriello A Ceriello, MD Hospital clínic i provincial de Barcelona
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Responsible Party: Anna Cruceta, Project manager, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT02109315    
Other Study ID Numbers: DIAB-01
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: April 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Inflammation
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Ascorbic Acid
Liraglutide
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypoglycemic Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents