Mechanisms of Endothelial Dysfunction in Type 2 Diabetes

NCT ID: NCT02311075

Last Updated: 2017-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patient comparative approach

Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples.

Group Type EXPERIMENTAL

Blood samples

Intervention Type BIOLOGICAL

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

Control subjects comparative approach

Assessing the availability of biological markers (NO, EETs, ET-1 and ROS) during endothelial stimulation using blood samples.

Group Type EXPERIMENTAL

Blood samples

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

Blood samples

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robinson JOANNIDES, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Rouen University Hospital

Rouen, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 30885203 (View on PubMed)

Other Identifiers

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2013-A01107-38

Identifier Type: OTHER

Identifier Source: secondary_id

2013/049/HP

Identifier Type: -

Identifier Source: org_study_id

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