CTRI

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CTRI Number

CTRI/2026/02/104200 [Registered on: 18/02/2026] Trial Registered Prospectively

Last Modified On:

17/02/2026

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Prediction Of Reduced Cognitive Performance In Type 2 Diabetes Mellitus Patients With Heart Autonomic Dysfunction.

Scientific Title of Study

Prediction Of Cognition Impairment In Elderly Type 2 Diabetes Mellitus Patients With Cardiac Autonomic Neuropathy.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Hina Gul
Designation	MPT STUDENT
Affiliation	CPRS,Jamia Millia Islamia
Address	Centre Of Physiotherapy And Rehabilitation Jamia Millia Islamia, New Delhi New Delhi DELHI 110025 India
Phone	7889705671
Fax
Email	hinamohd7733@gmail.com

Details of Contact Person
Scientific Query

Name	Aqsa Mujaddadi
Designation	Assistant Professor,cprs,Jamia Millia Islamia
Affiliation	Jamia Millia Islamia
Address	Room No 103,Ist Floor,Cprs,Jamia Millia Islamia,Jamia nagar , New Delhi New Delhi DELHI 110025 India
Phone	8130676908
Fax
Email	aqsamuj786@gmail.com

Details of Contact Person
Public Query

Name	Hina Gul
Designation	Student,MPT 4SEM
Affiliation	Jamia Millia Islamia
Address	Centre Of Physiotherapy And Rehabilitation ,Jamia Millia Islamia, New Delhi. South DELHI 110025 India
Phone	7889705671
Fax
Email	hinamohd7733@gmail.com

Source of Monetary or Material Support

Nil

Primary Sponsor

Name	Centre Of Physiotherapy And Rehabilitation
Address	Jamia Millia Islamia New Delhi
Type of Sponsor	Other [Central University]

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
Hina Gul	Centre Of Physiotherapy And Rehabilitation,Jamia Millia Islamia	Centre Of Physiotherapy And Rehabilitation, Room No 2 , Ground Floor PHD lab ,Centre Of Physiotherapy And Rehabilitation, ,Jamia Millia Islamia ,New Delhi South DELHI	7889705671 hinamohd7733@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Jamia Millia Islamia	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E114\|\|Type 2 diabetes mellitus with neurological complications,

Intervention / Comparator Agent

Type

Name

Details

Inclusion Criteria

Age From	60.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Group With Cognitively Normal Participants Age between 60 to 75 years Diagnosed with Type 2 Diabetes Mellitus T2DM for greater than 1year HbA1c greater than 6.5 percent Presence of Cardiac Autonomic Neuropathy CAN MoCA score greater than 26 Group With Mild to Moderate Cognitive Impairment Age between 60 to 75 years Diagnosed with Type 2 Diabetes Mellitus T2DM for 1year HbA1c greater than 6.5percent Presence of Cardiac Autonomic Neuropathy CAN MoCA score 23 to 26

ExclusionCriteria

Details

Group A Cognitively Normal Participants
MoCA score below 26
Any diagnosed neurological or psychiatric illness
Regular use of cognition altering medications
History of substance or alcohol abuse
Presence of sleep disorders
Group B Mild to Moderate Cognitive Impairment
MoCA score below 21 severe impairment
History of stroke or major CNS disorder not related to diabetes
Diagnosed major depression or psychosis
Use of drugs that interfere with autonomic or cognitive testing Inability to follow instructions or cooperate during assessments

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
HRV Sleep Quality	At Baseline

Secondary Outcome

Outcome	TimePoints
Nil	Nil

Target Sample Size

Total Sample Size="80"
Sample Size from India="80"
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)

01/03/2026

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="0"
Months="2"
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

This prospective cross-sectional study aims to predict cognitive impairment in individuals with Type 2 Diabetes Mellitus (T2DM) with Cardiac Autonomic Neuropathy (CAN). Cognitive dysfunction is increasingly recognized as a significant but underdiagnosed complication in diabetes, particularly in patients with autonomic dysfunction.Participants with T2DM will be assessed for the presence of CAN using heart rate variability (HRV)based autonomic function testing. Cognitive function will be evaluated using standardized cognitive assessment tools. Multimodal predictors including HRV parameters, eventrelated potentials (P300), sleep quality (Pittsburgh Sleep Quality Index), and physical activity levels (Physical Activity Scale for the Elderly) will be analyzed.The study aims to identify significant predictors of cognitive impairment and develop a predictive model using multivariate regression analysis. Early identification of high risk individuals may facilitate timely intervention and help prevent progression to dementia in this vulnerable population.