| CTRI Number |
CTRI/2025/10/096638 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of mild cognitive impairment and anxiety in Type 2 diabetes patients |
|
Scientific Title of Study
|
A cross-sectional study to assess mild cognitive impairment (MCI) and anxiety in Type 2 diabetes mellitus patients and the role of TLR4-NFKB signaling pathway in type 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 |
Dr Nilanjan Saha |
| Designation |
Professor and Head of Department |
| Affiliation |
Jamia Hamdard |
| Address |
Room no. 354, Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard, Mehrauli-Badarpur Rd Hamdard Nagar, New Delhi-110062
New Delhi
DELHI
110062
India |
| Phone |
9873013366 |
| Fax |
|
| Email |
nilanjan.saha@jamiahamdard.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ayesha |
| Designation |
PhD Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard, Mehrauli-Badarpur Rd Hamdard Nagar, New Delhi-110062
New Delhi
DELHI
110062
India |
| Phone |
8587890320 |
| Fax |
|
| Email |
phdpapers07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayesha |
| Designation |
PhD Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard, Mehrauli-Badarpur Rd Hamdard Nagar, New Delhi-110062
New Delhi
DELHI
110062
India |
| Phone |
8587890320 |
| Fax |
|
| Email |
phdpapers07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard, Mehrauli-Badarpur Rd Hamdard Nagar, New Delhi-110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard, Mehrauli-Badarpur Rd Hamdard Nagar, New Delhi-110062 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Ayesha |
ALSHIFA MULTISPECIALITY HOSPITAL |
D-305, Abul Fazal Enclave, Jamia Nagar, Okhla, New Delhi, Delhi 110025
New Delhi
DELHI |
08587890320
info@alshifahospital.net |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Instituional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for T2DM
1. Patients attending medicine OPD who had chronic T2DM of more than 3 years.
2. Age 18-65 years
3. Gender (Males, Females, Other)
4. Willingness to provide informed consent
5. Patients suffering from T2DM related MCI assessed using MMSE and MoCA
6. Patients suffering from T2DM related anxiety assessed using HAM-A
Inclusion criteria for Healthy Control
1. Patients having MMSE or MoCA scores more than 25
2. Patients having HAM-A scores less than 7
3. Patients without diagnosed T2DM, Anxiety and MCI and any other disease
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1.) Individuals with other comorbidities such as dementia, AD, etc.
2.) Clinical kidney or liver disease
3.) Current use of antibiotics or probiotics
4.) Pregnant and lactating females
5.) Patients with viral or bacterial infections |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
NIL
|
NIL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL
|
|
|
Target Sample Size
|
Total Sample Size="332"
Sample Size from India="332"
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)
|
11/11/2025 |
| 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="2"
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 - NO
|
|
Brief Summary
|
This study aims to investigate SERUM BIOMARKERS INCLUDING HMGB1 and TMAO for their role in Anxiety and Beta 2 microglobulin and claudin-5 as potential indicators of blood brain barrier disruption.YKL-40 Neuroinflammatory biomarker will be assesed to explore the contribution of neuroinflammation to both anxiety and mild cognitive impairment in T2DM. |