| CTRI Number |
CTRI/2025/08/092261 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
Study on the link between lung function, fitness, and quality of life in T2DM patients
|
|
Scientific Title of Study
|
Association of pulmonary function with
functional capacity and quality of life in patients with type 2diabetes mellitus (T2DM) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavita |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy,Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Medical Road, Rohtak |
| Address |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma
Post Graduate Institute of Medical Sciences
Rohtak
HARYANA
124001
India |
| Phone |
9350225238 |
| Fax |
|
| Email |
kavitakataria0987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meetu Nagpal |
| Designation |
Associate Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma
Post Graduate Institute of Medical Sciences
Rohtak
HARYANA
124001
India |
| Phone |
9416403155 |
| Fax |
|
| Email |
meetunagpalpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavita |
| Designation |
Post Graduate Student |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma
Post Graduate Institute of Medical Sciences
Rohtak
HARYANA
124001
India |
| Phone |
9350225238 |
| Fax |
|
| Email |
kavitakataria0987@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Medical Road, Rohtak (124001), Haryana |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy |
| Address |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma
Post Graduate Institute of Medical Sciences , Medical Road, Rohtak (124001), Haryana |
| 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 |
| Kavita |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
Department of medicine,Opd no.201,PGIMS
Rohtak
HARYANA |
9350225238
kavitakataria987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research 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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with DM2 for at least 2 month
Stable glycemic control (HbA1c less than or equal to 7 percent) |
|
| ExclusionCriteria |
| Details |
Patient of DM type I
• Communication difficulty
• Patients who were diagnosed with neurodegenerative diseases (ataxia, Alzheimer’s,
Parkinson’s)
• Musculoskeletal problems, such as fractures in general (hip, ankle, wrist, etc.)
• Severe cognitive impairment (dementia, memory loss and confusion)
• Severe cardiovascular disease (congestive heart failure) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulmonary Function Test
-FVC
-FEV1
-FEV1/FVC
-PEFR
6MWT
IPAQ
Multidimensional Fatigue Inventory-20
WHOQOL-Bref scale
Pittsburgh Sleep Quality Index |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
22/08/2025 |
| 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
|
The study aims to evaluate the association of pulmonary function with functional capacity, physical activity, sleep quality, and quality of life in patients with type 2 diabetes mellitus (T2DM). Participants aged over 40 years with a confirmed diagnosis of T2DM for more than one year will be recruited from the Department of Medicine, Pt. B.D. Sharma PGIMS, Rohtak. Following informed consent, demographic and clinical data, including anthropometric measurements and comorbidities, will be recorded.
Pulmonary function will be assessed using standard spirometric parameters: FVC, FEV1, FEV1/FVC ratio, and PEFR. Physical activity will be evaluated through the International Physical Activity Questionnaire (IPAQ), while functional capacity will be assessed using the Six-Minute Walk Test (6MWT). Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), and overall quality of life will be assessed using the WHOQOL-BREF questionnaire.
This observational study will provide insights into the relationship between lung function and key health-related outcomes in individuals with T2DM. |