| CTRI Number |
CTRI/2025/07/090879 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Blood sample collection] |
| Study Design |
Other |
|
Public Title of Study
|
Linking neuroinflammation to Type 2 diabetes mellitus associated cognitive impairment and depression |
|
Scientific Title of Study
|
Association of CaN/NFAT neuroinflammatory pathway with cognitive impairment and depression in Type 2 diabetes mellitus patients |
| 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 Nidhi |
| Designation |
Associate Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Tranlational and Clinical Research, School of chemical and Life Sciences, Jamia Hamdard, Mehrauli-Badarpur road, New Delhi-110062
South
DELHI
110062
India |
| Phone |
9818334770 |
| Fax |
|
| Email |
nidhiagarwal@jamiahamdard.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Nikita gupta |
| Designation |
Ph.D. Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Tranlational and Clinical Research, School of chemical and Life Sciences, Jamia Hamdard, Mehrauli-Badarpur road, New Delhi-110062
South
DELHI
110062
India |
| Phone |
962569970 |
| Fax |
|
| Email |
nikitamittal314@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikita gupta |
| Designation |
Ph.D. Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Tranlational and Clinical Research, School of chemical and Life Sciences, Jamia Hamdard, Mehrauli-Badarpur road, New Delhi-110062
DELHI
110062
India |
| Phone |
962569970 |
| Fax |
|
| Email |
nikitamittal314@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Translational and Clinical research, School of Chemical and Life Sciences, Jamia Hamdard, New Delhi-110062 |
|
|
Primary Sponsor
|
| Name |
Dr Nidhi |
| Address |
Jamia Hamdard, Mehrauli-Badarpur Road, New Delhi-110062 |
| Type of Sponsor |
Other [Self] |
|
|
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 SajadUlIslam |
Hakeem Abdul Hameed Centenary Hospital |
Department of Medicine, New Building, Majeedia Hospital, Mehrauli-Badarpur road, New Delhi-110062
South
DELHI |
9717979280
drsajad33@gmail.com |
|
|
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: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood Sample Collection |
A 5 mL venous blood sample was collected from each Type 2 Diabetes Mellitus (T2DM) patient using standard aseptic techniques. The samples were allowed to clot at room temperature and subsequently centrifuged to separate the serum. The obtained serum was stored at -80°C until further analysis. Enzyme-Linked Immunosorbent Assay (ELISA) kits specific to the biomarkers of interest were then used to quantitatively assess their concentrations according to the manufacturers protocol. |
| Comparator Agent |
Healthy controls |
Healthy volunteers without Type 2 Diabetes Mellitus (T2DM) or any known neuropsychiatric disorders will be recruited for the study. A 5 mL venous blood sample will be collected from each participant under sterile conditions. The samples will be processed and analyzed using Enzyme-Linked Immunosorbent Assay (ELISA) to quantify the levels of specific biomarkers. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from T2DM as assessed through laboratory parameters such as HbA1c, RBS and FBS.
Patients with low MMSE and MoCA scores and high HDRS and PHQ-9 scores |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating females
Patients of drug abuse or alcholism
Patients suffering from infectious diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Baseline assessment |
cross-sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
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
|
Chronic T2DM is often association various other complications such as atherosclerosis, obesity, hypertension and neuropsychiatric disorders such as mild cognitive impairment that can progress to dementia or Alzheimer’s and depression. My study involves assessment of T2DM patients and prediction of early biomarkers for the assessment of mild cognitive impairment and depression in such patients. Early assessment of mild cognitive impairment and depression in such patients will allow early intervention and development of personalized treatment plan for these patients in order to combat future prognosis of these abnormalities. Early intervention and care will provide a better quality of life and decreased risk of future complications associated with chronic T2DM. |