| CTRI Number |
CTRI/2024/11/076571 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Investigate the Link Between Hearing Loss and Diabetes Mellitus By assessing audiometry and blood sugar levels of patients |
|
Scientific Title of Study
|
Association Of Hearing Loss And Diabetes Mellitus In Tertiary Rural Care Centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragati Shikha |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal nehru medical college, wardha |
| Address |
144/B, Gandhinagar, Ramnagari sector 4,ashiana nagar, patna
T/26, radhika bai hostel , jnmc wardha
Patna
BIHAR
800025
India |
| Phone |
8247251794 |
| Fax |
|
| Email |
pragati.shikha2103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sagar Gaurkar |
| Designation |
Professor |
| Affiliation |
Jawaharlal nehru medical college, wardha |
| Address |
Department of ENT,
Block-C Ground floor,
AVBRH,
Sawangi,Wardha
MAHARASHTRA
442001
India |
| Phone |
9422902992 |
| Fax |
|
| Email |
shaggy6486@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pragati Shikha |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal nehru medical college, wardha |
| Address |
144/B, Gandhinagar, Ramnagari sector 4,ashiana nagar, patna
T/26, radhika bai hostel , jnmc wardha
BIHAR
800025
India |
| Phone |
8247251794 |
| Fax |
|
| Email |
pragati.shikha2103@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital, Sawangi(Meghe),Wardha-442004,
Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe institute of higher education and research sawangimeghewardha |
| Address |
Sawangi(Meghe),Wardha-442004
Maharashtra, India |
| Type of Sponsor |
Private 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 |
| Dr Pragati Shikha |
Acharya Vinoba Bhave Rural hospital |
Department of ENT
Block C, Ground Floor
AVBRH,
Sawangi, Wardha -442004
Wardha
MAHARASHTRA |
8247251794
pragati.shikha2103@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jawaharlal Nehru Medical College Sawangi (Megh), Wardha s |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H905||Unspecified sensorineural hearingloss, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
31.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with hearing loss from 31 to 65 years of age with a history of type 2 diabetes mellitus
Patient with normal middle ear function |
|
| ExclusionCriteria |
| Details |
Patient below 30 years of age
Patient above 65 years of age
Patient with type 1 diabetes mellitus
Patient with conductive, mixed hearing loss
Patient with abnormal middle ear functions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In this study, sample size of 125 patients aged 31 to 65 who visit the ENT outpatient department with complaints of reduced hearing will be assessed for elevated blood sugar levels. Additionally, patients attending the medicine outpatient department for high blood sugar will be evaluated for hearing loss, aiming to explore the association between hearing loss and type 2 diabetes mellitus in tertiary rural care centre |
In this study,in a time period of 36 months patients aged 31 to 65 who visit the ENT outpatient department with complaints of reduced hearing will be assessed for elevated blood sugar levels. Additionally, patients attending the medicine outpatient department for high blood sugar will be evaluated for hearing loss, aiming to explore the association between hearing loss and type 2 diabetes mellitus in tertiary rural care centre |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hearing loss is a common public health problem that affects work productivity, functional status,social interactions ,work life, well being and quality of life .The prevalence diabetes mellitus has increased over last 2 decades .Complications from this disease are common and are said to be due to Hyperglycemia induced microangiopathies. The presence of hearing defects in diabetic patients could be related Hyperglycemia or other associated conditions like decrease immunity that may predispose one to ear infection involving external ,middle ear and inner ear .Considering both hearing loss and diabetes mellitus are significant health issues, it is worth while to examine the relationship between the two. The purpose of this thesis is to examine the evidence linking diabetes with hearing loss and possible causal mechanism through an extensive review of literature. |