Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03847779 |
Other study ID # |
UAPV-012019-AVJ |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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).