CTRI

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CTRI Number

CTRI/2025/06/088560 [Registered on: 10/06/2025] Trial Registered Prospectively

Last Modified On:

25/08/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Evaluating Understanding of Type 2 Diabetes Mellitus and Correlation with HbA1C and the 6-minute walk distance test: An Observational Study

Scientific Title of Study

Assessing Knowledge in Type 2 Diabetes Mellitus and its correlation with 6 minutes walk distance test and HbA1C- An Observational Study.

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 Samrudhi Bele
Designation	PG student
Affiliation	MAEERs Physiotherapy college
Address	Department of Cardiovascular and Respiratory Physiotherapy, MAEERs Physiotherapy college, Talegaon Dabhade, Pune Pune MAHARASHTRA 410507 India
Phone	09834131215
Fax
Email	samrudhibele@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Varoon Jaiswal
Designation	Professor and Head of Department, Department of Cardiovascular and Respiratory Physiotherapy
Affiliation	MAEERs Physiotherapy college
Address	Department of Cardiovascular and Respiratory Physiotherapy, MAEERs Physiotherapy college, Talegaon Dabhade, Pune MAEERs Physiotherapy college, Talegaon Dabhade, Pune Pune MAHARASHTRA 410507 India
Phone	8999926162
Fax
Email	drvaroon@gmail.com

Details of Contact Person
Public Query

Name	Dr Varoon Jaiswal
Designation	Professor and Head of Department, Department of Cardiovascular and Respiratory Physiotherapy
Affiliation	MAEERs Physiotherapy college
Address	Department of Cardiovascular and Respiratory Physiotherapy, MAEERs Physiotherapy college, Talegaon Dabhade, Pune MAEERs Physiotherapy college, Talegaon Dabhade, Pune Pune MAHARASHTRA 410507 India
Phone	8999926162
Fax
Email	drvaroon@gmail.com

Source of Monetary or Material Support

MAEERs Physiotherapy College, Talegaon Tabhade, Pune, 410507

Primary Sponsor

Name	MAEERs physiotherapy college
Address	MAEERs physiotherapy college, Talegaon Dabhade, Pune
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
Nil	Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr SAMRUDHI BELE	Dr. Bhausaheb Sardesai Rural Hospital, Talegaon Dabhade, Pune	OPD no. 205, Department of Cardiovascular and Respiratory Physiotherapy, MAEERs Physiotherapy College, Dr. Bhausaheb Sardesai Rural Hospital, Talegaon, Nr Railway Station, Pune, Maharashtra 410507 Pune MAHARASHTRA	9834131215 samrudhibele@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
MAEERs Physiotherapy College Ethics Committee (MPCEC)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

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	1. Adult patients aged 18 years and above. 2. Confirmed diagnosis of Type 2 Diabetes (T2DM) by a healthcare professional. 3. Ability to perform the 6 Minute Walk Test (6MWT) safely and independently. 4. Willingness to participate in the study and provide informed consent. 5. Ability to understand and complete the Date-Q questionnaire.

ExclusionCriteria

Details

1. Patients with other types of diabetes (e.g., Type 1 Diabetes, gestational diabetes).
2. Any medical condition or physical impairment of lower limb that prevents the safe completion of the 6MWT.
3. Cognitive impairment or language barriers that hinder understanding or completion of the Date-Q questionnaire.
4. Recent surgery or major medical procedure within the past three months.
5. Known history of cardiovascular events such as myocardial infarction or stroke within the past six months.
6. Severe complications of diabetes such as diabetic ketoacidosis or hyperosmolar hyperglycemic state within the past three months.
7. Participation in another clinical trial or research study involving investigational drugs or interventions that may confound the results of this study.
8. Pregnancy or lactation in female participants.
9. Any condition or circumstance that, in the opinion of the investigator, may compromise the safety or validity of the study participation.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Six Minute Walk Distance Test	Baseline

Secondary Outcome

Outcome	TimePoints
HbA1C ,DATE Questionnaire	Baseline

Target Sample Size

Total Sample Size="194"
Sample Size from India="194"
Final Enrollment numbers achieved (Total)= "196"
Final Enrollment numbers achieved (India)="196"

Phase of Trial

N/A

Date of First Enrollment (India)

25/06/2025

Date of Study Completion (India)

10/06/2025

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

25/08/2025

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

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

An Observational Study on Patients with Type2 Diabetes Mellitus will be conducted. Patient’s knowledge about Type2 Diabetes Mellitus will be assessed. There 6 minute walk distance will be taken and also HbA1C data will be collected. Then data will be analyzed by using suitable statistical test.