Effects of Low Intensity Therapeutic Ultrasound on Endothelial Function

Universidade Federal de Santa Maria

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Low intensity therapeutic ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02872922

UFSM1

Details and patient eligibility

About

Endothelium is a cell layer that interposes blood and smooth muscle of vessels. This biological sensor reacts to physical and chemical stimuli by synthesis and/or liberation of regulatory substances like nitric oxide (NO), which acts on vascular tone, growth of muscle cells and platelet aggregation and leukocyte. Clinically, endothelial function measured by technique flow-mediated dilation (FMD) is a strong predictor of cardiovascular events and all-cause mortality. Previo study demonstrated that continuous and pulsed therapeutic 1-MHz ultrasound waveforms improved endothelial function in health volunteers and this vasodilation persisted for 20 min, which provided them with anti-inflammatory vascular effects. In subjects with type 2 diabetes (DM2) the chronical hyperglycemia and dyslipidemia reduce NO bioavailability causing endothelial dysfunction. Low intensity therapeutic ultrasound is an electrotherapeutic instrument employed in musculoskeletal injuries that promotes endothelium-dependent vasodilation, and its mechanism of action has not been studied on DM2. The aim of our study is evaluate endothelial function of patients with DM2 after different waveforms (placebo, continuous and pulsed) of therapeutic ultrasound. Therapeutic ultrasound is a electrotherapeutic instrument that can changes arterial endothelial function of subjects with DM2 because of NO bioavailability increasing, which implies anti-inflammatory and vasodilatory beneficial alterations for diabetic patients.

Full description

Evaluation of endothelial function will be made by flow-mediated dilation (FMD). The therapeutic ultrasound will applied over brachial artery using continuous (CUT: 0,4W/cm2), pulsed (PUT: 20% duty cycle, 0,08W/cm2SATA) and Placebo (equipment off) waveforms during 5min in 3 intercalated days.

Enrollment: 22 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subjects that joined the study will be alphabetized volunteers
• Age between 25 and 65 years old,
• Absence of morbid obesity,
• Non-smokers,
• With no symptoms of skeletal muscle disorders,
• No previous performing cardiovascular surgery,
• No previous diagnose of rheumatic, neurological, oncological, immune or hematologic diseases,
• Without evidence of psychiatric diseases and/or cognitive deficit.

Exclusion criteria

• Insulin dependent diabetes
• Leukocytosis, impaired fasting glycemia (<70 and >300 mg/dL) and
• Brachial artery diameter less than 2.5mm and larger than 5.0mm.
• On the day of the assessments have consumed of the alcoholic drink, caffeine and citrus juice

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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22 participants in 3 patient groups

Endothelial function after CWUT

Active Comparator group

Description:

Endothelial function of the all patients before and after application continuous waveform of ultrasound therapy (CWUT) measured by technique flow-mediated dilation (FMD).

Treatment:

Other: Low intensity therapeutic ultrasound

Endothelial function after PWUT

Active Comparator group

Description:

Endothelial function of the all patients before and after application pulsed waveform of ultrasound therapy (PWUT) measured by technique flow-mediated dilation (FMD).

Treatment:

Other: Low intensity therapeutic ultrasound

Endothelial function after PLACEBO

Active Comparator group

Description:

In the placebo intervention, all of the procedures above are repeated, but with the ultrasound equipment powered off. Endothelial function of the all patients before and after application placebo waveform of ultrasound therapy measured by technique flow-mediated dilation (FMD)

Treatment:

Other: Low intensity therapeutic ultrasound