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

Primary Purpose

Diabetes Mellitus Type 1

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Microvascular assessment
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diabetes type 1 patients
  • Matched control-subjects

Exclusion Criteria:

  • Patients or subjects with anti-inflammatory drugs

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Diabetes type 1 patients

Matched control-subjects

Arm Description

The intervention will be : Microvascular assessment with laser speckle contrast imaging

The intervention will be : Microvascular assessment with laser speckle contrast imaging

Outcomes

Primary Outcome Measures

Neurovascular microcirculatory response
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)

Secondary Outcome Measures

Full Information

First Posted
August 14, 2015
Last Updated
February 11, 2016
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02538120
Brief Title
Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1 Patients
Acronym
NEURODIAB1
Official Title
Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
The investigators will compare microvascular responses between diabetes type 1 patients with matched control-subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 1

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetes type 1 patients
Arm Type
Active Comparator
Arm Description
The intervention will be : Microvascular assessment with laser speckle contrast imaging
Arm Title
Matched control-subjects
Arm Type
Active Comparator
Arm Description
The intervention will be : Microvascular assessment with laser speckle contrast imaging
Intervention Type
Other
Intervention Name(s)
Microvascular assessment
Intervention Description
Microvascular assessment
Primary Outcome Measure Information:
Title
Neurovascular microcirculatory response
Description
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)
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diabetes type 1 patients Matched control-subjects Exclusion Criteria: Patients or subjects with anti-inflammatory drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Severine Dubois, MD
Organizational Affiliation
University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Angers
ZIP/Postal Code
49000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28287157
Citation
Marche P, Dubois S, Abraham P, Parot-Schinkel E, Gascoin L, Humeau-Heurtier A, Ducluzeau PH, Mahe G. Neurovascular microcirculatory vasodilation mediated by C-fibers and Transient receptor potential vanilloid-type-1 channels (TRPV 1) is impaired in type 1 diabetes. Sci Rep. 2017 Mar 13;7:44322. doi: 10.1038/srep44322.
Results Reference
derived

Learn more about this trial

Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1 Patients

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