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Trial record 32 of 228 for:    EDN1

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311075
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Biological: Blood samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Determination of the Mechanisms Involved in Conduit Artery Endothelial Dysfunction in Type 2 Diabetes
Study Start Date : December 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change from Baseline in EET concentration during endothelial stimulation [ Time Frame: 30 min from the beginning of hand skin heating ]

Secondary Outcome Measures :
  1. Change from Baseline in NO concentration during endothelial stimulation [ Time Frame: 30 min from the beginning of hand skin heating ]
  2. Change from Baseline in ET-1 concentration during endothelial stimulation [ Time Frame: 30 min from the beginning of hand skin heating ]
  3. Change from Baseline in ROS concentration during endothelial stimulation [ Time Frame: 30 min from the beginning of hand skin heating ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02311075


Locations
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France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Robinson JOANNIDES, MD Rouen University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02311075     History of Changes
Other Study ID Numbers: 2013/049/HP
2013-A01107-38 ( Other Identifier: ANSM )
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases