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Clinical Trials/CTRI/2024/06/068966
CTRI/2024/06/068966CompletedNot Applicable

The effects of type ii diabetes mellitus on auditory brainstem response

Deepika Yadav1 site in 1 country120 target enrollmentStarted: June 22, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
hearing loss

Study Overview

Brief Summary

It is a comparative cross sectional study. Total of 60 Type II Diabetics patients belonging to either sex, with age ranging between 35-65 years and duration of diabetes ranging more than 5 years were enrolled. Control group with age matched with study group were enrolled. Detailed history taken and clinical examination done. Informed consent will be taken. All cases and controls will be enrolled as per our strict inclusion and exclusion criteria.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
35.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Known case of Type II Diabetes (according to ADA diagnostic criteria) Type II Diabetics of more than 5 years of duration.

Exclusion Criteria

  • ubjects with ear disease, head injury and ear trauma.
  • History of previous ear surgery , ear discharge .
  • Ototoxic drugs intake like aminoglycosides.
  • Family history of deafness.

Outcomes

Primary Outcomes

hearing loss

Time Frame: 6 months

Secondary Outcomes

  • Hearing loss(6 months)

Investigators

Sponsor
Deepika Yadav
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Deepika Yadav

BRD Medical College Gorakhpur

Study Sites (1)

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