Microcirculatory Vasomotor Changes in Type 2 Diabetes With Peripheral Neuropathy (NEUROMICRO)
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| ClinicalTrials.gov Identifier: NCT03847779 |
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Recruitment Status :
Completed
First Posted : February 20, 2019
Last Update Posted : November 13, 2020
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Neuropathy Peripheral Small Vessel Disease of Diabetes Mellitus Vasodilation Vasoconstriction | Other: "Rest" Other: "Exercise" Other: "Foot lowering" Other: "Hyperthermia" | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 108 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Microcirculatory Vasomotor Function in Response to Acute Exercise in Type 2 Diabetes With Peripheral Neuropathy |
| Actual Study Start Date : | February 4, 2019 |
| Actual Primary Completion Date : | June 30, 2020 |
| Actual Study Completion Date : | June 30, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Non-neuropathy
Type 2 diabetic without neuropathy:
Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging:
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Other: "Rest"
Cutaneous perfusion and vasomotion assessment at rest in supoine position Other: "Exercise" Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test Other: "Foot lowering" Cutaneous perfusion and vasomotion assessment after foot lowering Other: "Hyperthermia" Cutaneous perfusion and vasomotion assessment during hyperthermia |
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Experimental: Neuropathy
Type 2 diabetic with neuropathy
Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging:
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Other: "Rest"
Cutaneous perfusion and vasomotion assessment at rest in supoine position Other: "Exercise" Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test Other: "Foot lowering" Cutaneous perfusion and vasomotion assessment after foot lowering Other: "Hyperthermia" Cutaneous perfusion and vasomotion assessment during hyperthermia |
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Experimental: Controls
matched for age, sexe and BMI with diabetic patients. Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging:
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Other: "Rest"
Cutaneous perfusion and vasomotion assessment at rest in supoine position Other: "Exercise" Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test Other: "Foot lowering" Cutaneous perfusion and vasomotion assessment after foot lowering Other: "Hyperthermia" Cutaneous perfusion and vasomotion assessment during hyperthermia |
- 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
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| Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- For diabetic patients, HbA1C >6.5 and diabetes duration >5years
- For healthy control no diabetes mellitus, no cardiovascular or renal pathology
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847779
| France | |
| Centre Hospitalier Henri Duffaut | |
| Avignon, France, 84 000 | |
| Principal Investigator: | Eric Benamo, MD | Centre Hospitalier Avignon |
| Responsible Party: | University of Avignon |
| ClinicalTrials.gov Identifier: | NCT03847779 |
| Other Study ID Numbers: |
UAPV-012019-AVJ |
| First Posted: | February 20, 2019 Key Record Dates |
| Last Update Posted: | November 13, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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vasomotion |
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Peripheral Nervous System Diseases Diabetic Neuropathies Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Neuromuscular Diseases Nervous System Diseases Diabetes Complications |