Clinical trial NCT04433273: Electrical Vestibular Stimulation (VeNS): Assessment of AMPK & SIRT1 Following Repeated Usage
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Neurovalens Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Compliance Solutions Ltd.
name: RD Gardi Medical College
First posted: 2020-06-16
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of SIRT1 (Sirtuin 1)
timeFrame: 4 weeks
measure: AMPK
timeFrame: 4 weeks
Secondary outcomes:
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 weeks
measure: The Epworth Sleepiness Scale (ESS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ujjain
country: India
facility: RD Gardi Medical College
state: Madhya Pradesh
Study officials:
References: