跳至主要内容
临床试验/NCT04433273
NCT04433273Unknown不适用

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.

Neurovalens Ltd.2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
36
试验地点
2
主要终点
Assessment of SIRT1 (Sirtuin 1)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female participants 35-60 years of age group Metabolic syndrome (BMI 25-35 kg/m2) Type 2 Diabetes Hyperlipidemia Willing participants

排除标准

  • Using Beta blockers Ear problems ( assessed during physical examination) Under any kind of therapy or treatment With severe complications Vestibular disorders

研究组 & 干预措施

Group A: Healthy control group

No Intervention

Neither placebo nor vestibular stimulation is administered

Group B: Placebo control group

Placebo Comparator

Placebo stimulation along with regular treatment

干预措施: Electrical vestibular nerve stimulation (Device)

Group C: Intervention group

Active Comparator

Electrical vestibular nerve stimulation along with regular treatment

干预措施: Electrical vestibular nerve stimulation (Device)

结局指标

主要结局

Assessment of SIRT1 (Sirtuin 1)

时间窗: 4 weeks

SIRT1 (Sirtuin 1) levels will be assessed from the blood samples by ELISA method using respective kits.

AMPK

时间窗: 4 weeks

AMPK levels will be assessed from the blood samples by ELISA method using respective kits.

次要结局

  • The Pittsburgh Sleep Quality Index (PSQI)(4 weeks)
  • The Epworth Sleepiness Scale (ESS)(4 weeks)

研究者

发起方
Neurovalens Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验