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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03172663
Other study ID # AUDIO
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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