| CTRI Number |
CTRI/2024/06/068966 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Implications of hyperglycemia on auditory function |
|
Scientific Title of Study
|
The effects of type ii diabetes mellitus on auditory brainstem response |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika Yadav |
| Designation |
Junior Resident |
| Affiliation |
BRD Medical College Gorakhpur |
| Address |
Department of Physiology BRD Medical College Gorakhpur
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
9695652519 |
| Fax |
|
| Email |
deepikayntw@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay Singh |
| Designation |
Head of Department Professor |
| Affiliation |
BRD Medical College Gorakhpur |
| Address |
Department of Physiology BRD Medical College
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
9450676223 |
| Fax |
|
| Email |
physiology.brd1972@Gmail.Com |
|
Details of Contact Person
Public Query
|
| Name |
Deepika Yadav |
| Designation |
Junior Resident |
| Affiliation |
BRD Medical College Gorakhpur |
| Address |
Department of Physiology BRD Medical College
Gorakhpur
UTTAR PRADESH
273013
India |
| Phone |
9695652519 |
| Fax |
|
| Email |
deepikayntw@gmail.com |
|
|
Source of Monetary or Material Support
|
| BRD Medical College Gorakhpur |
|
|
Primary Sponsor
|
| Name |
Deepika Yadav |
| Address |
BRD Medical College Gorakhpur 273013 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Deepika Yadav |
BRD Medical College |
Department of Physiology
Gorakhpur
UTTAR PRADESH |
9695652519
deepikayntw@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BRD Medical College Research Council |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Known case of Type II Diabetes (according to ADA diagnostic criteria)
Type II Diabetics of more than 5 years of duration |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| hearing loss |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hearing loss |
6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/06/2024 |
| Date of Study Completion (India) |
10/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. |