Microcirculatory Vasomotor Changes in Type 2 Diabetes With Peripheral Neuropathy

Vasodilation Clinical Trial

— NEUROMICRO  

Official title:

Microcirculatory Vasomotor Function in Response to Acute Exercise in Type 2 Diabetes With Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847779
• Other study ID #: UAPV-012019-AVJ
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2020
• Source: University of Avignon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Neuropathies
• Diabetic Neuropathy Peripheral
• Peripheral Nervous System Diseases
• Small Vessel Disease of Diabetes Mellitus
• Vasoconstriction
• Vasodilation

Intervention

Other:
• "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

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Duffaut	Avignon

Sponsors (1)

Lead Sponsor	Collaborator
University of Avignon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in average spectral amplitude of the entire frequency range between baseline and after stimulus	Spectral analysis by wavelet analysis	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