Mechanisms of Endothelial Dysfunction in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Biological: Blood samples

• Registration Number: NCT02311075
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-25
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-08
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from Baseline in EET concentration during endothelial stimulation	30 min from the beginning of hand skin heating

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in NO concentration during endothelial stimulation	30 min from the beginning of hand skin heating
Change from Baseline in ET-1 concentration during endothelial stimulation	30 min from the beginning of hand skin heating
Change from Baseline in ROS concentration during endothelial stimulation	30 min from the beginning of hand skin heating

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France