NCT02538120

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

May 1, 2012

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
Last Updated

February 12, 2016

Status Verified

August 1, 2015

Enrollment Period

3.3 years

First QC Date

August 14, 2015

Last Update Submit

February 11, 2016

Conditions

Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (1)

  • 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)

    one day

Study Arms (2)

Diabetes type 1 patients

ACTIVE COMPARATOR

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

Other: Microvascular assessment

Matched control-subjects

ACTIVE COMPARATOR

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

Other: Microvascular assessment

Interventions

Microvascular assessmentOTHER

Microvascular assessment

Diabetes type 1 patientsMatched control-subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes type 1 patients
  • Matched control-subjects

You may not qualify if:

  • Patients or subjects with anti-inflammatory drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, 49000, France

Location

Related Publications (1)

  • 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.

    PMID: 28287157DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Severine Dubois, MD

    University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 14, 2015

First Posted

September 2, 2015

Study Start

May 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 12, 2016

Record last verified: 2015-08

Locations

FR(1)