Diabetes Mellitus Type 1NEURODIAB1NCT02538120
Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1 Patients
A study testing Microvascular assessment in people with Diabetes Mellitus Type 1, run by University Hospital, Angers at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- Microvascular assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diabetes type 1 patients
- Matched control-subjects
Who cannot join
- Patients or subjects with anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the detailed description
The investigators will compare microvascular responses between diabetes type 1 patients with matched control-subjects.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- Microvascular assessment
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microvascular assessmentOther
Microvascular assessment
| Study group | Role | What they receive |
|---|---|---|
| Diabetes type 1 patients | Active comparator | The intervention will be : Microvascular assessment with laser speckle contrast imaging Receives: Other: Microvascular assessment |
| Matched control-subjects | Active comparator | The intervention will be : Microvascular assessment with laser speckle contrast imaging Receives: Other: Microvascular assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startMay 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Severine Dubois, MD, Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538120
- Sponsor's protocol ID
- 2012-A010008-35
- Acronym
- NEURODIAB1
- Status last verified
- Aug 2015
- First submitted
- 14 Aug 2015
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28287157
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1
- ClinicalTrials.gov ID
- NCT02538120
- Acronym / sponsor ID
- NEURODIAB1 / 2012-A010008-35
- Conditions
- Diabetes Mellitus Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- May 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes type 1 patients | Active comparator | Other: Microvascular assessmentThe intervention will be : Microvascular assessment with laser speckle contrast imaging |
| Matched control-subjects | Active comparator | Other: Microvascular assessmentThe intervention will be : Microvascular assessment with laser speckle contrast imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes type 1 patients
- Matched control-subjects
Key exclusion criteria (1 listed)
- Patients or subjects with anti-inflammatory drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microvascular assessmentMicrovascular assessment | Other | Diabetes type 1 patients, Matched control-subjects |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Derived from this study: PubMed 28287157Marche 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Severine Dubois, MD principal investigator
University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microvascular assessment in people with Diabetes Mellitus Type 1, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurovascular microcirculatory response (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02538120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.