| CTRI Number |
CTRI/2025/08/093560 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To study association between elevated risk of Obstructive Sleep Apnea and complications of type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
To study association between elevated risk of obstructive sleep apnoea in patients with type 2 Diabetes mellitus with complications of Diabetes mellitus |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kharat Anuja Dadasaheb |
| Designation |
Junior Resident |
| Affiliation |
Dr D Y Patil Medical College, Navi Mumbai |
| Address |
Department of general medicine, Dr D Y Patil Medical College, Navi Mumbai,
Thane
MAHARASHTRA
400706
India
Thane
MAHARASHTRA
400706
India |
| Phone |
8600295779 |
| Fax |
|
| Email |
anujakharat9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Purkar |
| Designation |
Professor and HOU General Medicine |
| Affiliation |
Dr D Y Patil Medical College, Navi Mumbai |
| Address |
Department of general medicine, Dr D Y Patil Medical College, Navi Mumbai,
Thane
MAHARASHTRA
400706
India
Thane
MAHARASHTRA
400706
India |
| Phone |
9892971979 |
| Fax |
|
| Email |
prashpurkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Purkar |
| Designation |
Professor and HOU General Medicine |
| Affiliation |
Dr D Y Patil Medical College, Navi Mumbai |
| Address |
Department of general medicine, Dr D Y Patil Medical College, Navi Mumbai,
Thane
MAHARASHTRA
400706
India
Thane
MAHARASHTRA
400706
India |
| Phone |
9892971979 |
| Fax |
|
| Email |
prashpurkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Medical College and Hospital, Nerul, Navi Mumbai, Maharashtra, India 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Kharat Anuja Dadasaheb |
| Address |
Department of General Medicine, Dr D Y Patil Medical College, Navi Mumbai |
| Type of Sponsor |
Other [Primary Investigator ] |
|
|
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 Kharat Anuja Dadasaheb |
Dr D Y Patil Hospital , Navi Mumbai |
OPD 1(General Medicine),Male medicine ward, Female Medicine ward, Intensive care unit, Dr D Y Patil Medical College and Hospital, Navi Mumbai
Thane
MAHARASHTRA |
8600295779
anujakharat9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for biomedical health and research (IECBH) of Dr D Y Patil Medical College, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients from OPD and Wards
Adult patients
Both genders
Patients daignosed with TYPE 2 DM |
|
| ExclusionCriteria |
| Details |
Patient with already diagnosed kidney disease of another etiology Retinopathy and neuropathy due to causes other than DM
Other diagnosed sleep disorders, severe Medical conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze the correlation between the severity of OSA (as assessed by screening tools) and the severity or presence of microvascular and macrovascular complications in type 2 DM patients. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To screen OSA in patients with type 2 Diabetes mellitus |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/09/2026 |
| 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="1"
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
|
Objectives of this study are to
1.To screen for OSA in patients in patients having type 2 Diabetes mellitus 2.To study if there is any association between having high risk of OSA and having complications of type 2 DM |