Metabolic desorders
Conditions
Interventions
Noninvasive Transcutaneous Vagus Nerve Electrical Stimulation Protocol (VNTES)
We used a NEMOSR device (http://www.cerbomed.de/) to perform the NTVNS. Stimulation of the upper part of the concha of th
Device
Biological/vaccine
E02.331.800
Sponsors
Universidade Nove de Julho-UNINOVE
Universidade Nove de Julho-UNINOVE
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Elected individuals met all the criteria listed below: Diagnosis of Metabolic Syndrome based on newly established criteria - three abnormal findings out of five qualify a person for the diagnosis of Metabolic Syndrome: Waist circumferential increase ( equal to or greater than 102cm in men; equal to or greater than 88cm in women); Increased triglycerides (equal to or higher 150 mg/dL); Reduced HDL-C (equal to or less than 40mg/dL in men; equal to or less than 50mg/dL in women); Increased blood pressure (systolic equal to or higher 130mmHg); and/or diastolic equal to or higher 85mm Hg); High fasting blood glucose (equal to or higher 100mg / dL); Patient declaration of stable weight and diet for at least six months until study entry; Normal renal function; Normal thyroid function; Able to declare written consent and compliance with study taxation along the study.
Exclusion criteria
Exclusion criteria: Subjects were not eligible to participate in the study if they met any of the exclusion criteria listed below: On antidiabetic medication or with HbA1c greater than 8.0%; Triglyceride levels equal or greater than 400mg / dL or on lipid-lowering medication; Serum alanine transaminase (AST) and / or aspartate transaminase (ALT) levels higher than 200U / L; Resting systolic pressure greater than or equal to 160 mm Hg; resting diastolic pressure greater than or equal to 100 mm Hg; Using antihypertensive drugs that interfere (beta blockers) with HRV; History of debilitating chronic diseases; Pregnancy; Volunteers presenting any active neoplasm; cutaneous lesion and / or sensitivity deficit of the left auricle; being on radiotherapy and / or chemotherapy and immunosuppressive treatment, patients with chronic infectious diseases (including hepatitis, Acquired Immunodeficiency Syndrome).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemodynamic evaluation Hemodynamic variables: systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), cardiac output (CD) and total peripheral resistance (TPR) were performed continuously and non-invasive, beat by beat, with Finomiter® pressure monitor. ;Autonomic Evaluation The autonomic parameters of heart rate variability in time and frequency domains, sympathovagal balance and blood pressure variability were obtained and evaluated by detecting systolic events (peak) of the beat-to-beat SBP signal. Pulse interval (PI) was estimated by the interval between consecutive systoles. After visual inspection of all series obtained, regularization of the periodicity was performed by cubic spline interpolation (fi = 250 Hz) and, after this, the reduction of the number of points per decimation (18 times). Each heartbeat was identified through the use of an algorithm through the Matlab MT program (Welch method), which automatically detected the systolic events of the pressure wave, generating the spectral analysis results with the respective ranges of interest. The spectral power was integrated into three frequency ranges of interest (HF, LF, VLF) and the ratio between two of them (LF / HF) was performed to assess the autonomic balance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Endothelial cell quantification by flow cytometry. Flow cytometry was quantified by the percentage of endothelial progenitor cells (CPE); Circulating Endothelial Cells (ECC), Microparticles (MP) and Monocytes (Classic and Non-Classic): Patients' blood was collected in an EDTA tube, then transferred 100µL to cytometry tubes according to the antibody groups: anti-CD14 (clasic monocyte); anti-CD16 (non-classical monocyte); anti-CD31 (circulating endothelial cell); anti-CD144 (microparticles) and anti-CD309 (endothelial progenitor cell). 2µL of the antibodies were pipetted into their respective groups and incubated in the dark at 4ºC for 30 minutes. After incubation, red blood cells were lysed according to the BD FACS Brand Lysing Solution reagent protocol (Catalog No. 349202), followed by centrifugation at 2,500 rpm for 10 minutes. The supernatant was discarded and the pellet resuspended in 2mL BSA, centrifuged again at 2,500 rpm for 10 minutes for the washing process. The supernatant was discarded and the final pellet resuspended in 200 µl BSA. ;Metabolic assessment and proinflammatory cytokines. A venipuncture (approximately 20 ml) was performed to remove a blood sample for the measurement of the relevant exams. Sample processing was performed according to standard and routine method in the clinical analysis laboratory and specific for each substance: C-Reactive Protein (PCR), Lipid Profile (Total Cholesterol), High Density Lipoproteins (HDL), Lipoproteins low density (LDL), Triglycerides, Thyroid function tests (free THS and T4), Liver function (TGO and TGP), fasting glucose and insulin. Women of childbearing potential have had a pregnancy test. Cytokine dosing (TNF alpha, IL-6) was performed by enzyme-linked immunosorbent assays (Quantikine HS ELISA - High Sensitivity) using commercial kits (R&D Systems a biotechne brand). | — |
Countries
Brazil
Contacts
Public ContactTércio de Morais
Universidade Nove de julho - Uninove
Outcome results
None listed