Mechanisms of Endothelial Dysfunction in Type 2 Diabetes (DIAB-EETs)

June 13, 2017 updated by: University Hospital, Rouen

Determination of the Mechanisms Involved in Conduit Artery Endothelial Dysfunction in Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

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

  • France
      • Rouen, France, 76031
        • Rouen University Hospital

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

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient comparative approach
Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples.
Biological: Blood samples
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
Experimental: Control subjects comparative approach
Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples.
Biological: Blood samples
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
Experimental: Healthy volunteers metabolic approach
Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples during hyperglycemia or hyperinsulinemia.
Biological: Blood samples
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in EET concentration during endothelial stimulation
Time Frame: 30 min from the beginning of hand skin heating
30 min from the beginning of hand skin heating

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in NO concentration during endothelial stimulation
Time Frame: 30 min from the beginning of hand skin heating
30 min from the beginning of hand skin heating
Change from Baseline in ET-1 concentration during endothelial stimulation
Time Frame: 30 min from the beginning of hand skin heating
30 min from the beginning of hand skin heating
Change from Baseline in ROS concentration during endothelial stimulation
Time Frame: 30 min from the beginning of hand skin heating
30 min from the beginning of hand skin heating

Collaborators and Investigators

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

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Robinson JOANNIDES, MD, Rouen University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/049/HP
  • 2013-A01107-38 (Other Identifier: ANSM)

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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