Body Mass Index and Audiology Function

NCT ID: NCT03172663

Last Updated: 2017-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-11-01

Brief Summary

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Obesity may directly or indirectly lead to hearing loss

Detailed Description

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Obesity is measured by Body Mass Index.it is calculated by dividing a person's weight in kilograms by the square of height in meters. For children and adolescent. Overweight is defined as Body Mass Index is \<85th percentile \<95th percentile but obesity is defined as body mass index at or above the 95th percentile for children and teens of the same age and sex the increasing in body mass index mass may affect auditory function Directly as adipose tissue secretes hormones and cytokines, proinflammatory cytokines lead to release of obesity-induced inflammation which may directly contribute to end-organ damage Also, Adiponectin, which is thought to have anti-inflammatory and antiatherogenic effects, and associated with favorable lipoprotein profile, independent of BMI and insulin resistance, low plasma concentrations of adiponectin have been associated with obesity in children. In adults, low level of adiponectin has been associated with elevated high-frequency thresholds.

Indirectly, by obesity comorbidities including Hypertension, Type 2 diabetes mellitus, Dyslipidemia , Metabolic Syndrome and Cardiovascular Diseases

Conditions

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Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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group 1

Group Type EXPERIMENTAL

pure tone audiometry

Intervention Type DEVICE

for estimate the type and degree of hearing loss

group 2

Group Type ACTIVE_COMPARATOR

pure tone audiometry

Intervention Type DEVICE

for estimate the type and degree of hearing loss

Interventions

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pure tone audiometry

for estimate the type and degree of hearing loss

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

It will include 50 subjects whose:

* Age ranges from 10 to 40 years old.
* Body Mass Index more than the 85th percentile.
* male and female will be included

Exclusion Criteria

* External or middle ear disease that causes conductive hearing loss such as otitis media, otomycosis, perforated drum, tumors, dislocation of the ossicles.
* High environmental noise exposure which causes acoustic trauma such as exploration, fire shots and noise in industries.
* ototoxic drug intake such as Aspirin, Aminoglycosides, Erythromycin, Vancomycin Streptomycin, Kanamycin, Neomycin, Gentamycin, Tobramycin, Lasix, Cisplatin, Nitrogen Mustard, and Vincristine, and Quinine.
* Major neurological or psychiatric diseases brain tumor, vestibular Schwannoma, stroke, acoustic neuroma, encephalitis, meningitis, and depression.
Minimum Eligible Age

10 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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NElshreef

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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mohammed salama bakr, Professor

Role: CONTACT

1006550289 ext. +20

amira Mohammad Abdel Moneim, Lecturer

Role: CONTACT

1095495110 ext. +20

References

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Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010. JAMA. 2012 Feb 1;307(5):483-90. doi: 10.1001/jama.2012.40. Epub 2012 Jan 17.

Reference Type BACKGROUND
PMID: 22253364 (View on PubMed)

Other Identifiers

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AUDIO

Identifier Type: -

Identifier Source: org_study_id

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