Microcirculatory Vasomotor Changes in Type 2 Diabetes With Peripheral Neuropathy
Condition: Diabetic Neuropathy Peripheral; Small Vessel Disease of Diabetes Mellitus; Vasodilation; Vasoconstriction
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetes Mellitus
Study type: Interventional

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).
    

Intervention name(s): "Rest"; "Exercise"; "Foot lowering"; "Hyperthermia"
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Cutaneous perfusion and vasomotion assessment at rest in supoine position; Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test; Cutaneous perfusion and vasomotion assessment after foot lowering; Cutaneous perfusion and vasomotion assessment during hyperthermia
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: vasomotion