Transcutaneous Electrical Nerve Stimulation (TENS) on Arterial Stiffness and Blood Pressure

Summary

Participation Requirements

Description

Patients will be divided into two groups: treatment and control (sham group). The sham group will be submitted to the procedure to fit the stimulation equipment. However, these patients will not be submitted to stimulation. Both groups will undergo a physical examination at the start and end of the ...

Patients will be divided into two groups: treatment and control (sham group). The sham group will be submitted to the procedure to fit the stimulation equipment. However, these patients will not be submitted to stimulation. Both groups will undergo a physical examination at the start and end of the study period to determine anthropometric variables. The BMI, defined as the weight (kg) divided by the patient's height squared (m2), will be calculated. The height will be determined in centimeters using a measuring tape with the individual barefoot. Individuals with BMI <25 kg/m² will be classified as normal, overweight as a BMI between 25 and 30 kg/m², and obese as a BMI ≥30 kg/m². The waist circumference will be measured using a measuring tape at half the distance between the iliac crest and the lower costal margin. Patients will undergo the following tests before and after the end of the four-week study period: 24-hour ambulatory blood pressure monitoring (ABPM), 24-hour dynamic electrocardiography, continuous measurement of beat-to-beat BP, endothelial function measurement and radial artery applanation tonometry (AT). Biochemical tests will be performed at two time points, before and after the four-week study period and include blood sugar, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), creatinine, potassium, uric acid, and plasma insulin levels. Blood sugar, TC, HDL-C and TG levels will be determined by colorimetry after fasting for 12 hours using a dimension device with the Dade Behring reagent. Diagnosis of diabetes mellitus (DM) will be established by patient history, the use of hypoglycemic drugs and measurement of the serum glucose. The LDL-C fraction will be calculated using the formula LDL-C = TC - HDL-C - TG / 5 (for TG <400 mg/dL). Additionally, the electrochemiluminescence method will be used to measure plasma insulin (immunoassay for the in vitro quantitative determination of human insulin in serum and plasma using the Elecsys 1010/2010 immunoassay and E170 modular analytics analyzers by Roche). The homeostasis model assessment of insulin resistance (HOMA-IR) index will be applied after obtaining blood sugar and insulin levels in order to determine insulin resistance and the functional capability of the pancreatic beta cells. Insulin resistance will be characterized when this ratio exceeds 2.71. The HOMA-IR index is calculated using the following formula: HOMA-IR: Fasting insulin (McU/mL) x fasting glucose (mmol/L*) 22.5 In order to convert the glucose concentration to mmol/L it is necessary to multiply the value in mg/dL by 0.0555. Measurement of serum creatinine will be performed by a standardized enzyme-kinetic biochemical test and will be considered high when serum creatinine >1.4 mg/dL. Urinary sodium and potassium levels (mEq/L) will be evaluated by flame photometry. Urinary sodium excretion will be calculated by multiplying the urinary sodium and potassium concentrations in mEq/L by the 24-hour urine volume. The 24-hour urine volume and urinary creatinine concentrations will be assessed to calculate creatinine clearance adjusted for body surface. Specific biochemical tests will be considered: serum aldosterone (AS), plasma renin activity (PRA), high-sensitivity C-reactive protein (hsCRP), metalloproteinase 9 (MMP-9), tissue inhibitor of metalloproteinases (TIMP-1 and TIMP-2), nitrites and nitrates, interleukin-1, 6, 8, 10 and 18 (IL-1, IL-6, IL-8, IL-10 and IL-18), tumor necrosis factor (TNF-α), thromboxane B2 (TXB2), fibrinogen, intercellular adhesion molecule (ICAM-1), plasminogen activator inhibitor (PAI-1), angiotensin converting enzyme (ACE) and angiotensin II (Ang II).

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