Back to resultsMechanisms of Endothelial Dysfunction in Type 2 Diabetes (DIAB-EETs)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetic patients or control subjects or healthy volunteers
Exclusion Criteria:
- Macroangiopathy
- Insulin treatment
- Chronic kidney disease (eGFR<60 ml/min/m²)
- Hyperlipidemia (total cholesterol>2.5 g/l)
- Smoking habit > 5 cigarettes/day
- Pregnancy
Sites / Locations
- Rouen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Patient comparative approach
Control subjects comparative approach
Healthy volunteers metabolic approach
Arm Description
Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples.
Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples.
Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples during hyperglycemia or hyperinsulinemia.
Outcomes
Primary Outcome Measures
Change from Baseline in EET concentration during endothelial stimulation
Secondary Outcome Measures
Change from Baseline in NO concentration during endothelial stimulation
Change from Baseline in ET-1 concentration during endothelial stimulation
Change from Baseline in ROS concentration during endothelial stimulation
Full Information
NCT ID
NCT02311075
First Posted
November 25, 2014
Last Updated
June 13, 2017
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT02311075
Brief Title
Mechanisms of Endothelial Dysfunction in Type 2 Diabetes
Acronym
DIAB-EETs
Official Title
Determination of the Mechanisms Involved in Conduit Artery Endothelial Dysfunction in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Endothelial dysfunction of conduit arteries plays an important role in the development of cardiovascular complications associated with type 2 diabetes. In order to propose targeted therapeutic approaches, this study aim to determine the mechanisms involved in endothelial dysfunction of conduit arteries in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient comparative approach
Arm Type
Experimental
Arm Description
Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples.
Arm Title
Control subjects comparative approach
Arm Type
Experimental
Arm Description
Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples.
Arm Title
Healthy volunteers metabolic approach
Arm Type
Experimental
Arm Description
Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples during hyperglycemia or hyperinsulinemia.
Intervention Type
Biological
Intervention Name(s)
Blood samples
Intervention Description
Blood samples will be performed at baseline and during endothelial stimulation by hand skin heating to quantify metabolites of NO, EETs, ET-1 and ROS
Primary Outcome Measure Information:
Title
Change from Baseline in EET concentration during endothelial stimulation
Time Frame
30 min from the beginning of hand skin heating
Secondary Outcome Measure Information:
Title
Change from Baseline in NO concentration during endothelial stimulation
Time Frame
30 min from the beginning of hand skin heating
Title
Change from Baseline in ET-1 concentration during endothelial stimulation
Time Frame
30 min from the beginning of hand skin heating
Title
Change from Baseline in ROS concentration during endothelial stimulation
Time Frame
30 min from the beginning of hand skin heating
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetic patients or control subjects or healthy volunteers
Exclusion Criteria:
Macroangiopathy
Insulin treatment
Chronic kidney disease (eGFR<60 ml/min/m²)
Hyperlipidemia (total cholesterol>2.5 g/l)
Smoking habit > 5 cigarettes/day
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robinson JOANNIDES, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
30885203
Citation
Duflot T, Moreau-Grange L, Roche C, Iacob M, Wils J, Remy-Jouet I, Cailleux AF, Leuillier M, Renet S, Li D, Morisseau C, Lamoureux F, Richard V, Prevost G, Joannides R, Bellien J. Altered bioavailability of epoxyeicosatrienoic acids is associated with conduit artery endothelial dysfunction in type 2 diabetic patients. Cardiovasc Diabetol. 2019 Mar 18;18(1):35. doi: 10.1186/s12933-019-0843-z.
Results Reference
derived
Learn more about this trial
Mechanisms of Endothelial Dysfunction in Type 2 Diabetes
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