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NCT02311075 Clinical Trial

Mechanisms of Endothelial Dysfunction in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— DIAB-EETs  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02311075
Other study ID # 2013/049/HP
Secondary ID 2013-A01107-38
Status Completed
Phase N/A
First received November 25, 2014
Last updated June 13, 2017
Start date December 2014
Est. completion date December 2016

Study information
Verified date June 2017
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Rouen University Hospital Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline in EET concentration during endothelial stimulation 30 min from the beginning of hand skin heating
Secondary Change from Baseline in NO concentration during endothelial stimulation 30 min from the beginning of hand skin heating
Secondary Change from Baseline in ET-1 concentration during endothelial stimulation 30 min from the beginning of hand skin heating
Secondary Change from Baseline in ROS concentration during endothelial stimulation 30 min from the beginning of hand skin heating
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