NCT02311075

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

November 25, 2014

Last Update Submit

June 13, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in EET concentration during endothelial stimulation

    30 min from the beginning of hand skin heating

Secondary Outcomes (3)

  • 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

Study Arms (3)

Patient comparative approach

EXPERIMENTAL

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

Biological: Blood samples

Control subjects comparative approach

EXPERIMENTAL

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

Biological: Blood samples

Healthy volunteers metabolic approach

EXPERIMENTAL

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

Interventions

Blood samplesBIOLOGICAL

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 approachHealthy volunteers metabolic approachPatient comparative approach

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Type 2 diabetic patients or control subjects or healthy volunteers

You may not qualify if:

  • Macroangiopathy
  • Insulin treatment
  • Chronic kidney disease (eGFR\<60 ml/min/m²)
  • Hyperlipidemia (total cholesterol\>2.5 g/l)
  • Smoking habit \> 5 cigarettes/day
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

Related Publications (1)

  • 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.

    PMID: 30885203DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Robinson JOANNIDES, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

December 8, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations

FR(1)