Clinical trial NCT03847779: Microcirculatory Vasomotor Changes in Type 2 Diabetes With Peripheral Neuropathy
Official title: Microcirculatory Vasomotor Function in Response to Acute Exercise in Type 2 Diabetes With Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy Peripheral
Small Vessel Disease of Diabetes Mellitus
Vasodilation
Vasoconstriction
Keywords: vasomotion
Lead sponsor: University of Avignon
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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. 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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in average spectral amplitude of the entire frequency range between baseline and after stimulus
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Avignon
country: France
facility: Centre Hospitalier Henri Duffaut
Study officials:
affiliation: Centre Hospitalier Avignon
name: Eric Benamo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.