Microcirculatory Vasomotor Changes in Type 2 Diabetes With Peripheral Neuropathy
NCT ID: NCT03847779
Last Updated: 2020-11-13
Study Results
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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COMPLETED
NA
108 participants
INTERVENTIONAL
2019-02-04
2020-06-30
Brief Summary
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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
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* 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
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Non-neuropathy
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)
"Rest"
Cutaneous perfusion and vasomotion assessment at rest in supoine position
"Exercise"
Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test
"Foot lowering"
Cutaneous perfusion and vasomotion assessment after foot lowering
"Hyperthermia"
Cutaneous perfusion and vasomotion assessment during hyperthermia
Neuropathy
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)
"Rest"
Cutaneous perfusion and vasomotion assessment at rest in supoine position
"Exercise"
Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test
"Foot lowering"
Cutaneous perfusion and vasomotion assessment after foot lowering
"Hyperthermia"
Cutaneous perfusion and vasomotion assessment during hyperthermia
Controls
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)
"Rest"
Cutaneous perfusion and vasomotion assessment at rest in supoine position
"Exercise"
Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test
"Foot lowering"
Cutaneous perfusion and vasomotion assessment after foot lowering
"Hyperthermia"
Cutaneous perfusion and vasomotion assessment during hyperthermia
Interventions
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"Rest"
Cutaneous perfusion and vasomotion assessment at rest in supoine position
"Exercise"
Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test
"Foot lowering"
Cutaneous perfusion and vasomotion assessment after foot lowering
"Hyperthermia"
Cutaneous perfusion and vasomotion assessment during hyperthermia
Eligibility Criteria
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Inclusion Criteria
* For healthy control no diabetes mellitus, no cardiovascular or renal pathology
Exclusion Criteria
* 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
40 Years
75 Years
ALL
Yes
Sponsors
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University of Avignon
OTHER
Responsible Party
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Principal Investigators
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Eric Benamo, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Avignon
Locations
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Centre Hospitalier Henri Duffaut
Avignon, , France
Countries
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References
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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.
Other Identifiers
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UAPV-012019-AVJ
Identifier Type: -
Identifier Source: org_study_id