| CTRI Number |
CTRI/2024/03/063950 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
To study the Factors affecting adherence to Physical activity in patients of type 2 diabetes mellitus |
|
Scientific Title of Study
|
Factors affecting adherence to physical activity in patients of 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 |
Jaspreet Singh Anand |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 126, 1st floor, medicine department, BL Taneja block, MAMC, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9555110032 |
| Fax |
|
| Email |
anand.jaspreetsingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Pandit |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 126, 1st floor, BL Taneja Block, MAMC, 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 number 126, 1st floor, BL Taneja Block, MAMC, New Delhi
DELHI
110002
India |
| Phone |
9968604386 |
| Fax |
|
| Email |
spandit01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical college and Lok Nayak hospital |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical college |
| Address |
Maulana Azad medical college and associated Lok Nayak hospital, G.I.P.M.E.R. And G.N.E.C. Hospitals, 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 Jaspreet Singh Anand |
Lok Nayak Hospital |
Maulana Azad medical college and associated Lok Nayak hospital, G.I.P.M.E.R. And G.N.E.C. Hospitals, New Delhi - 110002
New Delhi
DELHI |
9555110032
anand.jaspreetsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Type 2 Diabetes Mellitus of duration more than 5 years.
Patients who give written informed consent |
|
| ExclusionCriteria |
| Details |
Pregnancy.
Patients suffering from any neuropsychiatric illness.
Patients suffering from any Acute or chronic degenerative/inflammatory condition of joints.
Patients suffering from co morbid chronic medical diseases including chronic kidney disease, chronic liver disease, chronic heart failure, 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 of Type 2 Diabetes Mellitus who are adequately or inadequately physically active according to the CDC recommendation for physical acitivity |
Baseline, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing the proportion of physically active patients of Type 2 Diabetes Mellitus with patient variables such as age, sex, socioeconomic status, presence of peripheral neuropathy, duration of Type 2 Diabetes Mellitus, type of treatment received for diabetes. |
Baseline, 4 weeks, 8 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)
|
25/03/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anand.jaspreetsingh@gmail.com].
- For how long will this data be available start date provided 18-09-2025 and end date provided 18-02-2040?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Lifestyle modifications (including physical activity) are inseparable from the prevention and management of Type 2 Diabetes Mellitus. Regular physical activity reduces insulin resistance and also prevents cardiovascular complications in patients of Type 2 Diabetes Mellitus. Despite this, diabetic patients struggle to adhere to the recommended physical activity goals. This study aims to assess how physically active diabetic patients are. The study will also evaluate the causes for diabetic patients’ inability to achieve the expected physical activity goals. |