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Effects of Low Intensity Therapeutic Ultrasound on Endothelial Function

U

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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