Electrical Vestibular Stimulation (VeNS): Assessment of AMPK & SIRT1 Following Repeated Usage

Overweight and Obesity Clinical Trial

Official title:

A Randomized, Double-blind, Sham-controlled Trial to Evaluate Changes in AMPK Following Daily Vestibular Nerve Stimulation (VeNS) in Adults Who Are Overweight or Obese.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04433273
• Other study ID #: IVS002A
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Neurovalens Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The vestibular system which is responsible for balance and equilibrium constitutes our sixth sense. Metabolic Syndrome is a constellation of metabolic abnormalities characterized by obesity, insulin resistance (diabetes mellitus), hypertension, and dyslipidemia. It is generally agreed that a combination of three or more of the following components must be present: large waist circumference, elevated triglyceride, decreased high-density lipoprotein (HDL) cholesterol raised blood pressure, and elevated fasting blood sugar (FBS). Sirtuin 1 (SIRT1) is one of seven mammalian orthologs of the yeast protein silent information regulator. It is a conserved NAD-dependent protein deacetylase that decreases in cells that have high insulin resistance. In vivo, insulin resistance and metabolic syndrome were associated with low SIRT1 gene and protein expression. SIRT1 plays an important role to stimulate AMPK in improving mitochondrial function both in-vitro and in-vivo. Adenosine 5'-monophosphate (AMP)-activated protein kinase (AMPK) is a key factor in regulating energy metabolism, placing it at the center stage in studies of diabetes and related metabolic disorders like metabolic syndrome. It was reported that over a period of 6 weeks regular vestibular rehabilitation exercises caused an increase in the expression of SIRT1. The sleep inducing effects of vestibular stimulation is well known. Earlier studies reported improvement in the scores of Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) followed by the vestibular stimulation. Hence, we hypothesize that vestibular stimulation will lead to up-regulation of both SIRT1 and AMPK.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

Inclusion Criteria:

Male and female participants 35-60 years of age group Metabolic syndrome (BMI 25-35 kg/m2) Type 2 Diabetes Hyperlipidemia Willing participants Exclusion Criteria: Using Beta blockers Ear problems ( assessed during physical examination) Under any kind of therapy or treatment With severe complications Vestibular disorders

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Device:
• Electrical vestibular nerve stimulation
Electrical vestibular nerve stimulation using a headset device

Locations

Country	Name	City	State
India	RD Gardi Medical College	Ujjain	Madhya Pradesh

Sponsors (3)

Lead Sponsor	Collaborator
Neurovalens Ltd.	Compliance Solutions Ltd., RD Gardi Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of SIRT1 (Sirtuin 1)	SIRT1 (Sirtuin 1) levels will be assessed from the blood samples by ELISA method using respective kits.	4 weeks
Primary	AMPK	AMPK levels will be assessed from the blood samples by ELISA method using respective kits.	4 weeks
Secondary	The Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a standard questionnaire used to assess sleep quality and quantity for the last month. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.; Minimum value = 0 Maximum value = 21	4 weeks
Secondary	The Epworth Sleepiness Scale (ESS)	The Epworth Sleepiness Scale (ESS) is a standard questionnaire used as a subjective measure of a patient's sleepiness.; Minimum value = 0 Maximum value = 24 A higher score indicates worse outcome (excessive sleepiness)	4 weeks