Diabetic Neuropathy PeripheralNEUROMICRONCT03847779
Microcirculatory Vasomotor Changes in Type 2 Diabetes With Peripheral Neuropathy
A study testing "Rest", "Exercise" and "Foot lowering" in people with Diabetic Neuropathy Peripheral and Small Vessel Disease of Diabetes Mellitus, run by University of Avignon at 1 site in France.
Trial summary
Microcirculatory flow is subject to cyclic changes under the influence of heart rate, respiration, myogenic activity, neurogenic factors and endothelial factors. Microcirculatory oscillations (vasomotion) contribute significantly to tissue perfusion. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Neuropathy Peripheral, Small Vessel Disease of Diabetes Mellitus, Vasodilation
- What is being tested?
- "Rest", "Exercise" and "Foot lowering"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2019to 30 Jun 2020
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For diabetic patients, HbA1C >6.5 and diabetes duration >5years
- For healthy control no diabetes mellitus, no cardiovascular or renal pathology
Who cannot join
- nondiabetic neuropathy
- on medication known to affect microcirculation
- presence of active foot ulcer or wound healing history <3months
- inability to walk 6 minutes
- alcohol consumption of more than 3 units per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microcirculatory Vasomotor Function in Response to Acute Exercise in Type 2 Diabetes With Peripheral Neuropathy
Microcirculatory flow is subject to cyclic changes under the influence of heart rate, respiration, myogenic activity, neurogenic factors and endothelial factors. Microcirculatory oscillations (vasomotion) contribute significantly to tissue perfusion. Vasomotion analysis allowed to discriminate normoglycemic subjects, prediabetic subjects and diabetic subjects. Furthermore, changes in vasomotion can precede the emergence of global signs of microangiopathy complications in type 2 diabetes. In fact, few studies reported impaired vasomotion in type 2 diabetes with peripheral neuropathy. Vasomotion analysis after vasodilator (6-min walking test and hyperthermia) and after vasoconstrictor (foot lowering) stimulus could be an effective diagnostic tool to sharpen the diagnostic.
Objectives and Methodology: to study vasomotion at baseline and after exercise, hyperthermia and foot lowering within 3 groups of patients: diabetic without peripheral neuropathy, diabetic with subclinical peripheral neuropathy and diabetic with peripheral neuropathy and one group of sex- age- and body mass index-matched healthy control subjects.
All the subjects will benefit from a clinical, anthropometric, level of physical activity and biological evaluations. Type 2 diabetes participants will benefit from neuropathy evaluation. In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).
Read the detailed description
All the subjects will benefit from a:
- clinical: diabetes duration, treatments
- anthropometric: weight, height, BMI
- level of physical activity by means of the International Physical Activity Questionary, pedometers and the 6 minutes walking test
- biological evaluations: glycemia, HbA1C, lipids, high sensitive C-reactive protein, fibrinogen, 25(OH)D, creatinine, albumine Type 2 diabetes participants will benefit from neuropathy evaluation: sensory tests by means of Semmes-Weinstein monofilament and of Nerve Check, amplitude and velocity sural nerve and neuropathic symptom score (NSS) In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).
- Conditions
- Diabetic Neuropathy Peripheral, Small Vessel Disease of Diabetes Mellitus, Vasodilation, Vasoconstriction
- Being tested
- "Rest", "Exercise", "Foot lowering", "Hyperthermia"
- Keywords
- vasomotion
- Medical subject headings
- Diabetic Angiopathies, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Rest"Other
Cutaneous perfusion and vasomotion assessment at rest in supoine position
"Exercise"Other
Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test
"Foot lowering"Other
Cutaneous perfusion and vasomotion assessment after foot lowering
"Hyperthermia"Other
Cutaneous perfusion and vasomotion assessment during hyperthermia
| Study group | Role | What they receive |
|---|---|---|
| Non-neuropathy | Experimental | Type 2 diabetic without neuropathy:
* Negative findings on Semmes-Weinstein monofilament
* Neuropathy symptom score (NSS) <3
* Negative findings on Nerve Check and Diabetic Peripheral Neuropathy check.
Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging:
* "rest" cutaneous microcirculation (perfusion and vasomotion)
* "Exercise" cutaneous microcirculation (perfusion and vasomotion)
* "Foot lowering" cutaneous microcirculation (perfusion and vasomotion)
* "Hyperthermia" cutaneous microcirculation (perfusion and vasomotion)
* blood sampling
* heart rate variability at rest
* pedometer during 4 days
* international Physical Activity Questionary
* Qualify of Life questionary (EQVOD) Receives: Other: "Rest"; Other: "Exercise"; Other: "Foot lowering"; Other: "Hyperthermia" |
| Neuropathy | Experimental | Type 2 diabetic with neuropathy
* Positive findings on Semmes-Weinstein monofilament
* Neuropathy symptom score (NSS) >3
* Positive findings on Nerve Check and Diabetic Peripheral Neuropathy check.
Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging:
* "rest" cutaneous microcirculation (perfusion and vasomotion)
* "Exercise" cutaneous microcirculation (perfusion and vasomotion)
* "Foot lowering" cutaneous microcirculation (perfusion and vasomotion)
* "Hyperthermia" cutaneous microcirculation (perfusion and vasomotion)
* blood sampling
* heart rate variability at rest
* pedometer during 4 days
* international Physical Activity Questionary
* Qualify of Life questionary (EQVOD) Receives: Other: "Rest"; Other: "Exercise"; Other: "Foot lowering"; Other: "Hyperthermia" |
| Controls | Experimental | matched for age, sexe and BMI with diabetic patients.
Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging:
* "rest" cutaneous microcirculation (perfusion and vasomotion)
* "Exercise" cutaneous microcirculation (perfusion and vasomotion)
* "Foot lowering" cutaneous microcirculation (perfusion and vasomotion)
* "Hyperthermia" cutaneous microcirculation (perfusion and vasomotion)
* blood sampling
* heart rate variability at rest
* international Physical Activity Questionary
* Qualify of Life questionary (EQVOD) Receives: Other: "Rest"; Other: "Exercise"; Other: "Foot lowering"; Other: "Hyperthermia" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in average spectral amplitude of the entire frequency range between baseline and after stimulus
Spectral analysis by wavelet analysis
Measured: Cutaneous blood flow will be recorded during 20 minutes at rest, 10 minutes after foot lowering, 15 minutes after exercise and 20 minutes during hyperthermia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start4 Feb 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
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 Diabetic Neuropathy PeripheralStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Avignon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Benamo, MD, Principal investigator, Centre Hospitalier Avignon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847779
- Sponsor's protocol ID
- UAPV-012019-AVJ
- Acronym
- NEUROMICRO
- Status last verified
- Nov 2020
- First submitted
- 28 Jan 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reynes C, Beaume JB, Latil-Plat F, Ennaifer H, Rocher L, Antoine-Jonville S, Benamo E, Knapp Y, Vinet A. Concomitant Peripheral Neuropathy and Type 2 Diabetes Impairs Postexercise Cutaneous Perfusion and Flowmotion. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e3979-e3989. doi: 10.1210/clinem/dgab414.
PubMed 34111245
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculatory Vasomotor Function in Response to Acute Exercise in Type 2 Diabetes With Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT03847779
- Acronym / sponsor ID
- NEUROMICRO / UAPV-012019-AVJ
- Conditions
- Diabetic Neuropathy Peripheral, Small Vessel Disease of Diabetes Mellitus, Vasodilation, Vasoconstriction
- Keywords
- vasomotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of AvignonUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 20 Feb 2019 (actual)
- 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.
Microcirculatory flow is subject to cyclic changes under the influence of heart rate, respiration, myogenic activity, neurogenic factors and endothelial factors. Microcirculatory oscillations (vasomotion) contribute significantly to tissue perfusion. Vasomotion analysis allowed to discriminate normoglycemic subjects, prediabetic subjects and diabetic subjects. Furthermore, changes in vasomotion can precede the emergence of global signs of microangiopathy complications in type 2 diabetes. In fact, few studies reported impaired vasomotion in type 2 diabetes with peripheral neuropathy. Vasomotion analysis after vasodilator (6-min walking test and hyperthermia) and after vasoconstrictor (foot lowering) stimulus could be an effective diagnostic tool to sharpen the diagnostic.
Objectives and Methodology: to study vasomotion at baseline and after exercise, hyperthermia and foot lowering within 3 groups of patients: diabetic without peripheral neuropathy, diabetic with subclinical peripheral neuropathy and diabetic with peripheral neuropathy and one group of sex- age- and body mass index-matched healthy control subjects.
All the subjects will benefit from a clinical, anthropometric, level of physical activity and biological evaluations. Type 2 diabetes participants will benefit from neuropathy evaluation. In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).
Detailed description
All the subjects will benefit from a:
- clinical: diabetes duration, treatments
- anthropometric: weight, height, BMI
- level of physical activity by means of the International Physical Activity Questionary, pedometers and the 6 minutes walking test
- biological evaluations: glycemia, HbA1C, lipids, high sensitive C-reactive protein, fibrinogen, 25(OH)D, creatinine, albumine Type 2 diabetes participants will benefit from neuropathy evaluation: sensory tests by means of Semmes-Weinstein monofilament and of Nerve Check, amplitude and velocity sural nerve and neuropathic symptom score (NSS) In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-neuropathy | Experimental | Other: "Rest", Other: "Exercise", Other: "Foot lowering", Other: "Hyperthermia"Type 2 diabetic without neuropathy: * Negative findings on Semmes-Weinstein monofilament * Neuropathy symptom score (NSS) <3 * Negative findings on Nerve Check and Diabetic Peripheral Neuropathy check. Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging: * "rest" cutaneous microcirculation (perfusion and vasomotion) * "Exercise" cutaneous microcirculation (perfusion and vasomotion) * "Foot lowering" cutaneous microcirculation (perfusion and vasomotion) * "Hyperthermia" cutaneous microcirculation (perfusion and vasomotion) * blood sampling * heart rate variability at rest * pedometer during 4 days * international Physical Activity Questionary * Qualify of Life questionary (EQVOD) |
| Neuropathy | Experimental | Other: "Rest", Other: "Exercise", Other: "Foot lowering", Other: "Hyperthermia"Type 2 diabetic with neuropathy * Positive findings on Semmes-Weinstein monofilament * Neuropathy symptom score (NSS) >3 * Positive findings on Nerve Check and Diabetic Peripheral Neuropathy check. Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging: * "rest" cutaneous microcirculation (perfusion and vasomotion) * "Exercise" cutaneous microcirculation (perfusion and vasomotion) * "Foot lowering" cutaneous microcirculation (perfusion and vasomotion) * "Hyperthermia" cutaneous microcirculation (perfusion and vasomotion) * blood sampling * heart rate variability at rest * pedometer during 4 days * international Physical Activity Questionary * Qualify of Life questionary (EQVOD) |
| Controls | Experimental | Other: "Rest", Other: "Exercise", Other: "Foot lowering", Other: "Hyperthermia"matched for age, sexe and BMI with diabetic patients. Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging: * "rest" cutaneous microcirculation (perfusion and vasomotion) * "Exercise" cutaneous microcirculation (perfusion and vasomotion) * "Foot lowering" cutaneous microcirculation (perfusion and vasomotion) * "Hyperthermia" cutaneous microcirculation (perfusion and vasomotion) * blood sampling * heart rate variability at rest * international Physical Activity Questionary * Qualify of Life questionary (EQVOD) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For diabetic patients, HbA1C >6.5 and diabetes duration >5years
- For healthy control no diabetes mellitus, no cardiovascular or renal pathology
Key exclusion criteria (5 listed)
- nondiabetic neuropathy
- on medication known to affect microcirculation
- presence of active foot ulcer or wound healing history <3months
- inability to walk 6 minutes
- alcohol consumption of more than 3 units per day
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 |
|---|---|---|
| "Rest"Cutaneous perfusion and vasomotion assessment at rest in supoine position | Other | Controls, Neuropathy, Non-neuropathy |
| "Exercise"Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test | Other | Controls, Neuropathy, Non-neuropathy |
| "Foot lowering"Cutaneous perfusion and vasomotion assessment after foot lowering | Other | Controls, Neuropathy, Non-neuropathy |
| "Hyperthermia"Cutaneous perfusion and vasomotion assessment during hyperthermia | Other | Controls, Neuropathy, Non-neuropathy |
Primary outcome
Changes in average spectral amplitude of the entire frequency range between baseline and after stimulus
Time frame: Cutaneous blood flow will be recorded during 20 minutes at rest, 10 minutes after foot lowering, 15 minutes after exercise and 20 minutes during hyperthermia
Spectral analysis by wavelet analysis
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 13 Nov 2020.
- Derived from this study: PubMed 34111245Reynes C, Beaume JB, Latil-Plat F, Ennaifer H, Rocher L, Antoine-Jonville S, Benamo E, Knapp Y, Vinet A. Concomitant Peripheral Neuropathy and Type 2 Diabetes Impairs Postexercise Cutaneous Perfusion and Flowmotion. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e3979-e3989. doi: 10.1210/clinem/dgab414.
- Individual participant dataSharing planned: No
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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.
Eric Benamo, MD principal investigator
Centre Hospitalier Avignon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Rest", "Exercise" and "Foot lowering" in people with Diabetic Neuropathy Peripheral and Small Vessel Disease of Diabetes Mellitus, run by University of Avignon 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 5 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 13 Nov 2020. 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?
Changes in average spectral amplitude of the entire frequency range between baseline and after stimulus (time frame: Cutaneous blood flow will be recorded during 20 minutes at rest, 10 minutes after foot lowering, 15 minutes after exercise and 20 minutes during hyperthermia). 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 NCT03847779, 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 13 Nov 2020.