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Completed

NCT Number: NCT03847779

Microcirculatory Vasomotor Changes in Type 2 Diabetes With Peripheral Neuropathy

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).

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Key information

Conditions

Diabetic Neuropathy Peripheral Aneurysm Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Small Vessel Disease of Diabetes Mellitus Vascular Diseases Vasoconstriction Vasodilation

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Henri Duffaut

Avignon, 84 000, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Rest"

Other

Cutaneous perfusion and vasomotion assessment at rest in supoine position

"Exercise"

Other

Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test

"Foot lowering"

Other

Cutaneous perfusion and vasomotion assessment after foot lowering

"Hyperthermia"

Other

Cutaneous perfusion and vasomotion assessment during hyperthermia

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Avignon

Other

Registry information

Official study title

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

Acronym: NEUROMICRO

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2019
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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