Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1 Patients (NEURODIAB1)

February 11, 2016 updated by: University Hospital, Angers

Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1

This study aims to see whether or not the diabetes 1 patients have a neurovascular microcirculatory dysfunction using various microvascular tests which have been previously validated.

Microvascular responses will be assessed by Laser Speckle Contrast Imaging and expressed in Laser Speckle Perfusion Units (LSPU).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will compare microvascular responses between diabetes type 1 patients with matched control-subjects.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetes type 1 patients
  • Matched control-subjects

Exclusion Criteria:

  • Patients or subjects with anti-inflammatory drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diabetes type 1 patients
The intervention will be : Microvascular assessment with laser speckle contrast imaging
Other: Microvascular assessment
Microvascular assessment
Active Comparator: Matched control-subjects
The intervention will be : Microvascular assessment with laser speckle contrast imaging
Other: Microvascular assessment
Microvascular assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurovascular microcirculatory response
Time Frame: one day
Neurovascular response will be assessed by laser speckle contrast imaging using various microvascular tests such as deionized water iontophoresis, local heating test. Results will be explained in Laser Speckle Perfusion Units (LSPU)
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Severine Dubois, MD, University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Estimate)

February 12, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A010008-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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