Body Mass Index and Audiology Function

Hearing Loss Clinical Trial

Official title:

Effect of Increased Body Mass Index on Auditory Function

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03172663
• Other study ID #: AUDIO
• Status: Not yet recruiting
• Phase: N/A
• First received: May 26, 2017
• Last updated: June 4, 2017
• Start date: May 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: mohammed salama bakr, Professor
• Phone: 1006550289
• Email: mohamedsalamabakr[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obesity may directly or indirectly lead to hearing loss

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• pure tone audiometry
for estimate the type and degree of hearing loss

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body mass index	if increased body mass index affect auditory function assessed by pure tone audiomertry	20 minutes