Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1 Patients

NCT ID: NCT02538120

Last Updated: 2016-02-12

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-09-30

Brief Summary

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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

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

Conditions

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Diabetes Mellitus Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Diabetes type 1 patients

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

Group Type ACTIVE_COMPARATOR

Microvascular assessment

Intervention Type OTHER

Microvascular assessment

Matched control-subjects

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

Group Type ACTIVE_COMPARATOR

Microvascular assessment

Intervention Type OTHER

Microvascular assessment

Interventions

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Microvascular assessment

Microvascular assessment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diabetes type 1 patients
* Matched control-subjects

Exclusion Criteria

* Patients or subjects with anti-inflammatory drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Severine Dubois, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital

Locations

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University Hospital

Angers, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 28287157 (View on PubMed)

Other Identifiers

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2012-A010008-35

Identifier Type: -

Identifier Source: org_study_id

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