Effects of Low Intensity Therapeutic Ultrasound on Endothelial Function

September 20, 2017 updated by: Luis Ulisses Signori, Universidade Federal de Santa Maria

Effects of Therapeutic Ultrasound on Endothelial Function of Patients With Type 2 Diabetes Mellitus: Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Rio Grande, RS, Brazil, 96200-190
        • Universidade Federal do Rio Grande

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endothelial function after CWUT
Endothelial function of the all patients before and after application continuous waveform of ultrasound therapy (CWUT) measured by technique flow-mediated dilation (FMD).
Other: Low intensity therapeutic ultrasound
The ultrasound equipment (Sonopulse III, 1 MHz, IBRAMED, Brazil) was calibrated with the radiation force method. In study, the head of the transducer will be positioned and applied for 5 min over the brachial artery at the same point that will be evaluated the endothelium function (Cruz et al., 2016). Continuous waveforms of ultrasound therapy (CWUT) are applied in the stationary mode for 5 minutes at a spatial averaged temporal intensity (SATA) of 0.4 W/cm2 using a transducer 1-MHz. A pulsed waveform of ultrasound therapy (PWUT) are applied (5 minutes) with a 20% duty cycle (2 ms on, 8 ms off), which represents a constant intensity of 0.08 W/cm2 SATA. In the placebo intervention, all of the procedures above are repeated, but with the ultrasound equipment powered off (Cruz et al., 2016).
Other Names:
  • Ultrasonic therapy, Ultrasound
Active Comparator: Endothelial function after PWUT
Endothelial function of the all patients before and after application pulsed waveform of ultrasound therapy (PWUT) measured by technique flow-mediated dilation (FMD).
Other: Low intensity therapeutic ultrasound
The ultrasound equipment (Sonopulse III, 1 MHz, IBRAMED, Brazil) was calibrated with the radiation force method. In study, the head of the transducer will be positioned and applied for 5 min over the brachial artery at the same point that will be evaluated the endothelium function (Cruz et al., 2016). Continuous waveforms of ultrasound therapy (CWUT) are applied in the stationary mode for 5 minutes at a spatial averaged temporal intensity (SATA) of 0.4 W/cm2 using a transducer 1-MHz. A pulsed waveform of ultrasound therapy (PWUT) are applied (5 minutes) with a 20% duty cycle (2 ms on, 8 ms off), which represents a constant intensity of 0.08 W/cm2 SATA. In the placebo intervention, all of the procedures above are repeated, but with the ultrasound equipment powered off (Cruz et al., 2016).
Other Names:
  • Ultrasonic therapy, Ultrasound
Active Comparator: Endothelial function after PLACEBO
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)
Other: Low intensity therapeutic ultrasound
The ultrasound equipment (Sonopulse III, 1 MHz, IBRAMED, Brazil) was calibrated with the radiation force method. In study, the head of the transducer will be positioned and applied for 5 min over the brachial artery at the same point that will be evaluated the endothelium function (Cruz et al., 2016). Continuous waveforms of ultrasound therapy (CWUT) are applied in the stationary mode for 5 minutes at a spatial averaged temporal intensity (SATA) of 0.4 W/cm2 using a transducer 1-MHz. A pulsed waveform of ultrasound therapy (PWUT) are applied (5 minutes) with a 20% duty cycle (2 ms on, 8 ms off), which represents a constant intensity of 0.08 W/cm2 SATA. In the placebo intervention, all of the procedures above are repeated, but with the ultrasound equipment powered off (Cruz et al., 2016).
Other Names:
  • Ultrasonic therapy, Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of the endothelium-dependent vasodilation (%FMD)
Time Frame: Five minutes after application of therapeutic ultrasound

Vessel diameter responses to reactive hyperemia are expressed as percentage change in relation to diameter before cuff inflation (%FMD = [(hyperemia maximum diameter - baseline precuff diameter)/(baseline precuff diameter)] / 100) (Corretti et al. 2002; Thijssen et al. 2011).

Baseline precuff diameter is expressed in millimeter (mm). Hyperemia maximum diameter is expressed in millimeter (mm). Arterial endothelium-dependent vasodilation are evaluated by technique flow-mediated dilation (FMD) with high-resolution vascular ultrasound and a 5- to 12-MHz linear transducer (Logiq P6, GE Healthcare, GE Ultrasound Korea), according to the American Heart Association Guidelines (Corretti et al. 2002), with adjustments (Thijssen et al. 2011).
Five minutes after application of therapeutic ultrasound

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of the endothelium-independent vasodilation (%NMD)
Time Frame: Five minutes after application of therapeutic ultrasound
Endothelium-independent vasodilation is measured after sublingual nitroglycerin (NMD) spray (0.4 mg). Vessel diameter responses nitroglycerin are expressed as percentage change in relation to diameter before cuff inflation and before drug administration (%NMD = [(nitroglycerin maximum diameter - baseline precuff diameter)/(baseline precuff diameter)] / 100) (Corretti et al. 2002; Iida et al. 2006; Thijssen et al. 2011). Baseline precuff diameter is expressed in millimeter (mm) and Nitroglycerin maximum diameter is expressed in millimeter (mm).
Five minutes after application of therapeutic ultrasound

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Santa Maria

Investigators

  • Principal Investigator: Luis U Signori, PhD, Universidade Federal de Santa Maria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2016

Primary Completion (Actual)

September 20, 2017

Study Completion (Actual)

September 20, 2017

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFSM1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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