Back to resultsVitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes. (DIAB-01)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Withdrawn
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Vitamine C
Liraglutide 6 mg
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
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.
Sites / Locations
- Hospital Clinic i Provincial de Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Liraglutide endovenous 6 mg
Vitamine C
Arm Description
Liraglutide endovenous de 0.6 mg. one time a day
C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min
Outcomes
Primary Outcome Measures
Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery.
Secondary Outcome Measures
Oxidative stress markers
Oxidative stress markers (nitrotyrosine and 8-iso prostaglandin F2 alpha plasma) in serum1 inflammation markers (serum sICAM-1, interleukin 6) 1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02109315
Brief Title
Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes.
Acronym
DIAB-01
Official Title
Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Withdrawn
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Cruceta
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liraglutide endovenous 6 mg
Arm Type
Experimental
Arm Description
Liraglutide endovenous de 0.6 mg. one time a day
Arm Title
Vitamine C
Arm Type
Experimental
Arm Description
C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min
Intervention Type
Drug
Intervention Name(s)
Vitamine C
Intervention Description
C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min
Intervention Type
Drug
Intervention Name(s)
Liraglutide 6 mg
Intervention Description
Liraglutide endovenous de 0.6 mg. one time a day
Primary Outcome Measure Information:
Title
Endothelial dysfunction (Flow mediated dilation): Endothelial function is assessed measuring flow-mediated vasodilation (FMD) of the brachial artery.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Oxidative stress markers
Description
Oxidative stress markers (nitrotyrosine and 8-iso prostaglandin F2 alpha plasma) in serum1 inflammation markers (serum sICAM-1, interleukin 6) 1
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Ceriello A Ceriello, MD
Organizational Affiliation
Hospital clínic i provincial de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Vitamin C and Liraglutide Effects on Hypoglycemia-induced Oxidative Stress, Inflammation and Endothelial Dysfunction in Type 1 Diabetes.
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