Clinical trial NCT02872922: Effects of Low Intensity Therapeutic Ultrasound on Endothelial Function
Official title: Effects of Therapeutic Ultrasound on Endothelial Function of Patients With Type 2 Diabetes Mellitus: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Endothelial function
Ultrasonic Therapy
Vascular endothelium
Nitric oxide
Ultrasound
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of the endothelium-dependent vasodilation (%FMD)
timeFrame: Five minutes after application of therapeutic ultrasound
Secondary outcomes:
measure: Percentage of the endothelium-independent vasodilation (%NMD)
timeFrame: Five minutes after application of therapeutic ultrasound
Other outcomes:
Locations:
city: Rio Grande
country: Brazil
facility: Universidade Federal do Rio Grande
state: RS
Study officials:
affiliation: Universidade Federal de Santa Maria
name: Luis U Signori, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Shechter M, Shechter A, Koren-Morag N, Feinberg MS, Hiersch L. Usefulness of brachial artery flow-mediated dilation to predict long-term cardiovascular events in subjects without heart disease. Am J Cardiol. 2014 Jan 1;113(1):162-7. doi: 10.1016/j.amjcard.2013.08.051. Epub 2013 Oct 5.
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citation: Xu Y, Arora RC, Hiebert BM, Lerner B, Szwajcer A, McDonald K, Rigatto C, Komenda P, Sood MM, Tangri N. Non-invasive endothelial function testing and the risk of adverse outcomes: a systematic review and meta-analysis. Eur Heart J Cardiovasc Imaging. 2014 Jul;15(7):736-46. doi: 10.1093/ehjci/jet256. Epub 2014 Jan 7.
citation: Cruz JM, Hauck M, Cardoso Pereira AP, Moraes MB, Martins CN, da Silva Paulitsch F, Plentz RD, Peres W, Vargas da Silva AM, Signori LU. Effects of Different Therapeutic Ultrasound Waveforms on Endothelial Function in Healthy Volunteers: A Randomized Clinical Trial. Ultrasound Med Biol. 2016 Feb;42(2):471-80. doi: 10.1016/j.ultrasmedbio.2015.10.002. Epub 2015 Nov 12.