Effect of Increased Body Mass Index on Auditory Function
| Registry | NCT03172663 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: single, prevention |
| Enrollment | 50 (Estimated) |
| Sponsor | Assiut University (Other) |
| Conditions | Hearing Loss |
| Interventions | pure tone audiometry (Device) |
| Dates | start 2018-05-01 (estimated), primary completion 2019-05-01 (estimated), completion 2019-11-01 (estimated), first posted 2017-06-01, last updated 2017-06-06 |
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Obesity may directly or indirectly lead to hearing loss
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| group 1 | Experimental | Device: pure tone audiometry | |
| group 2 | Active comparator | Device: pure tone audiometry |
Sex: All, ages: 10 Years to 40 Years, accepts healthy volunteers
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.