Effects of Vagus Nerve Electric Stimulation upon the autonomic nervous system, cardiac function and inflammation in patients with the Metabolic Syndrome

Not Applicable

• Conditions: Metabolic desorders; Systemic Arterial Hypertension; Type 2 Diabetes Mellitus; E70-E90; C14.907.489.165; C18.452.394.750.149

• Registration Number: RBR-7thswq
• Lead Sponsor: niversidade Nove de Julho-UNINOVE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Intervention
• Study Design: Not specified