Vasodilation Clinical Trial
— NEUROMICROOfficial title:
Microcirculatory Vasomotor Function in Response to Acute Exercise in Type 2 Diabetes With Peripheral Neuropathy
Verified date | November 2020 |
Source | University of Avignon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Henri Duffaut | Avignon |
Lead Sponsor | Collaborator |
---|---|
University of Avignon |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
Active, not recruiting |
NCT06454084 -
Investigation of Endothelium-dependent Vasodilation in Human Gingiva
|
N/A | |
Recruiting |
NCT05997732 -
Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences
|
Phase 4 | |
Recruiting |
NCT06117007 -
Effects of Betalains on Cardiovascular Health and Quality of Life
|
N/A | |
Completed |
NCT03659864 -
The Role of Eicosanoids in the Cardiovascular Actions of Inhaled Nanoparticles
|
N/A | |
Completed |
NCT03459027 -
Nitrate Supplementation and Muscle Blood Flow
|
N/A | |
Recruiting |
NCT04255160 -
Impact of Estradiol on Endothelial Function in Peri-Menopausal Women
|
Phase 4 | |
Recruiting |
NCT05522075 -
Reducing Blood Pressure in Mid-life Adult Binge Drinkers
|
N/A | |
Completed |
NCT00184886 -
The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans
|
N/A | |
Completed |
NCT02095873 -
Healthy Aging Through Functional Food
|
Phase 1/Phase 2 | |
Completed |
NCT02292342 -
An Investigation of the Dose-dependent Vascualr Effects of (-)-Epicatechin in Healthy Men
|
Phase 0 | |
Completed |
NCT00901745 -
Interaction of Apelin and Angiotensin in the Human Forearm Circulation
|
N/A | |
Not yet recruiting |
NCT06290713 -
Vasodilator and Exercise Study for DMD (VASO-REx)
|
Phase 2 | |
Completed |
NCT02265107 -
Effects of Exercise Training on Vascular Endothelial Function of Patients Submitted to Coronary Artery Bypass Graft
|
N/A | |
Recruiting |
NCT05219799 -
Sex Disparities in Hypoxic Vasodilation and Impact of Obesity
|
Early Phase 1 | |
Completed |
NCT03622060 -
Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion
|
Phase 3 | |
Not yet recruiting |
NCT06417177 -
Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia
|
Early Phase 1 | |
Completed |
NCT01618071 -
Vascular Effects of Triglyceride-rich Lipoproteins
|
N/A | |
Completed |
NCT03190304 -
The Effect of Neprilysin (LCZ696) on Exercise Tolerance in Patients With Heart Failure
|
Phase 4 | |
Completed |
NCT04928183 -
The Impact of Carbon Monoxide and Altitude on Vascular Function
|
N/A |