Ignite Creation Date:
2024-05-06 @ 2:49 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04433273
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2020-06-12
Brief Title:
Electrical Vestibular Stimulation VeNS Assessment of AMPK SIRT1 Following Repeated Usage
Sponsor:
Neurovalens Ltd
Organization:
Neurovalens Ltd
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None