| CTRI Number |
CTRI/2025/02/081428 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the Quality of Sleep in Patients with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Quality of Sleep in Patients with Type 2 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 |
Abhinay Anand |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 126, Department of General Medicine, 1st Floor, B. L. Taneja Block, Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8809412940 |
| Fax |
|
| Email |
abhinay.anand39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Pandit |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 126, Department of General Medicine, 1st Floor, B. L. Taneja Block, Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604386 |
| Fax |
|
| Email |
spandit01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Pandit |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 126, Department of General Medicine, 1st Floor, B. L. Taneja Block, Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604386 |
| Fax |
|
| Email |
spandit01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India - 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi -110002 |
| 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 |
| Dr Abhinay Anand |
Lok Nayak Hospital |
Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi - 110002
New Delhi
DELHI |
8809412940
abhinay.anand39@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and associated Hospital (Lok Nayak, GIPMER and GNEC), New Delhi, India - 110002 (Institutional Ethics Committee) |
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 |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Type 2 Diabetes Mellitus of duration more than 4 years |
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Patient suffering from any neuropsychiatric illness like depression, schizophrenia, etc.
3. Patient suffering from any acute or chronic painful condition.
4. Patient suffering from co morbid chronic medical diseases including -
a. Chronic kidney disease
b. Chronic liver disease
c. Chronic heart failure
d. Chronic obstructive pulmonary disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with type 2 diabetes mellitus who are good sleepers (PSQI score of less than 5) and poor sleepers (PSQI score of more than or equal to 5). |
Baseline, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of sleep quality with glycemic control (HbA1c). |
Baseline, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/03/2025 |
| 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
|
Sleep is a basic human need which is required for the healthy functioning of the mind and the body. Diabetes Mellitus has been found to be one of the common chronic medical conditions leading to
sleep disorders. Poor
sleep quality in turn can lead to worsening of glycemic control. This can thus lead to a viscous cycle
of poor sleep quality and uncontrolled blood sugar. This study aims to assess the quality of sleep in patients of Type 2 Diabetes Mellitus and to find the correlation between quality of sleep and glycemic control of the patient. |