| CTRI Number |
CTRI/2025/12/099861 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
How a Ghrelin gene variant may influence cognitive health in people with type 2 diabetes. |
Scientific Title of Study
Modification(s)
|
ASSOCIATION OF GHRELIN GENE (GHRL) POLYMORPHISM (rs4684677) WITH COGNITIVE STATUS IN 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 |
Dr Smita Kaushik |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Biochemistry Pathology block, Maulana Azad Medical College,2 Bahadur Shah Zafar Marg
Central
DELHI
110002
India
New Delhi
DELHI
110002
India |
| Phone |
9968604230 |
| Fax |
|
| Email |
smitakaushik77@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Choudhary |
| Designation |
PG resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Biochemistry Pathology block, Maulana Azad Medical College,2 Bahadur Shah Zafar Marg
New Delhi
DELHI
110002
India |
| Phone |
9530017184 |
| Fax |
|
| Email |
sumanchoudhary1911@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Choudhary |
| Designation |
PG resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Biochemistry Pathology block, Maulana Azad Medical College,2 Bahadur Shah Zafar Marg
New Delhi
DELHI
110002
India |
| Phone |
9530017184 |
| Fax |
|
| Email |
sumanchoudhary1911@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,2 Bahadur Shah Zafar Marg 11002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2 Bahadur Shah Zafar NEW DELHI-110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Biochemistry |
Maulana Azad Medical College
New Delhi
110002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suman Choudhary |
Maulana Azad Medical College |
Room no.211, Department of Biochemistry Pathology block, Maulana Azad Medical College,2 Bahadur Shah Zafar Marg
Central DELHI
New Delhi
DELHI |
09530017184
sumanchoudhary1911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital(Lok Nayak, G.I.P.M.E.R.,Guru Nanak Eye Centre, New Delhi-110002) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No History of any substance abuse which may affect cognitive function. |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
For Cases:Known diabetic patients diagnosed with T2DM,atleast for the last 5 years as per ADA criteria.On treatment,without any other known metabolic,surgical,or psychiatric comorbid condition.
For Control:Healthy volunteers
|
|
| ExclusionCriteria |
| Details |
For Cases: Patient admitted with acute complications of Diabetes mellitus.
For Control: history of any substance abuse which may affect cognitive function.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Frequency of Ghrelin gene (rs4684677) polymorphism among T2DM patients and Healthy volunteers.
2.Mean serum Ghrelin levels in pg/mL and Cognitive status scores in both groups. |
2 Months Sample collection
1 month sample processing
2 weeks Data collection and analysis
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Association between gene polymorphism and cognitive status.
2.Association between ghrelin level and cognitive status.
3.Mean HOMA-IR values in T2DM patients and healthy volunteers |
2 Months Sample collection
1 month sample processing
2 weeks Data collection and analysis |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
20/01/2026 |
| 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="6"
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
|
The primary aim is to detect GHRL rs4684677 polymorphism and measure plasma ghrelin levels alongside cognitive function in T2DM patients versus controls. T2DM drives cognitive decline via insulin resistance and inflammation, with ghrelin offering neuroprotective potential. This study links genetic variation, hormone levels, and MoCA-assessed cognition to elucidate early DCI mechanisms |