| CTRI Number |
CTRI/2025/10/096395 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of gene expression in circulating leukocytes in type 2 diabetes mellitus in western Uttar Pradesh |
|
Scientific Title of Study
|
Evaluation of sirt1 and sirt4 gene expression in circulating leukocytes in type 2 diabetes mellitus in western Uttar Pradesh |
| 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 Ijen Bhatacharya |
| Designation |
Professor |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Biochemistry
Government Institute of Medical Sciences (GIMS)
Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9953993987 |
| Fax |
|
| Email |
ijen.bhatta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Fatima Iram |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Biochemistry
Government Institute of Medical Sciences (GIMS)
Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9971528771 |
| Fax |
|
| Email |
iramfatima2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fatima Iram |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Biochemistry
Government Institute of Medical Sciences (GIMS)
Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9971528771 |
| Fax |
|
| Email |
iramfatima2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences (GIMS) Kasna Greater Noida Gautam Buddha Nagar Uttar Pradesh Pin 201310 |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences (GIMS) |
| Address |
Kasna Greater Noida Gautam Buddha Nagar Uttar Pradesh Pin 201310 |
| Type of Sponsor |
Government medical college |
|
|
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 Deepak Sharma |
Government Institute of Medical Sciences (GIMS) |
OPD, 10 Ground floor, Department of Medicine
GIMS Hispital Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
8218517253
deepak.102sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GIMS Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified 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 |
Adults aged between 35 to 60 years.
1.Diagnosed cases of uncontrolled Type 2 Diabetes Mellitus as per ADA criteria and with
HbA1c levels greater than or equal 7 percent will be collected from dept of Medicine.
2.Willing to provide written informed consent.
3.For control group: age- and sex-matched apparently healthy individuals without a history of diabetes. |
|
| ExclusionCriteria |
| Details |
1.Patients with Type 1 Diabetes Mellitus or other forms of secondary diabetes.
2.Individuals with acute or chronic infections, inflammatory diseases, hypertension or
malignancies.
3.Patients with renal disease, liver disease, or recent cardiovascular disease, smocker.
4.Pregnant or lactating women.
5.Individuals on immunosuppressive therapy or antioxidant supplements, lipid lowering drugs.
6.Participants unwilling to give informed consent or adhere to study procedur |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the gene expression levels of SIRT1 and SIRT4 between T2DM patients and
apparently healthy controls |
At the time of Enrollment only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess biochemical parameters including insulin,Superoxide dismutase 2,Interleukin 4
,HOMA-IR in T2DM patient & apparently healthy controls.
2.To correlate the insulin,Superoxide dismutase 2,interleukin 4 & HOMA-IR with SIRT1
,SIRT4 expression in T2DM patient & apparently healthy controls. |
At the time of Enrollment only |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
30/10/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
1. Background of the study • Type 2 Diabetes Mellitus (T2DM) is a global health challenge, affecting over 589 million adults, with rising prevalence.1 • SIRT1 and SIRT4 are key metabolic regulators involved in insulin sensitivity, inflammation, and mitochondrial function2 • Studies suggest downregulation of SIRT1 and SIRT4 in patients with T2DM.3 • This study aims to evaluate SIRT1 and SIRT4 gene expression in peripheral blood leukocytes and assess their involvement in T2DM pathophysiology. • During Fasting,calorie restriction,NAD levels in the cell increses which leads activation of SIRT 1 gene causes deacetylation of certain factors like p53,FOX01,PGC1 alpha,NF-kB which causes enhanced mitochondrial function,increase stress resistance,suppression of apoptosis,anti-inflammatory effects leads to anti aging effects,metabolic balance and longetivity.3 • SIRT4 gene expression leads to transcription and translation into SIRT4 protien,SIRT4 act as mitochondrial enzyme regulator which has ADP ribosyl transferase,lipoamidase,deacylase.Due to these enzyme activity,it inhibits Glutamate Dehydrogenase(GDH) further reduces conversion of glutamate to alpha ketoglutarate.This leads to ADP/ATP ration modulation and downregulate insulin secretion and improves glucose tolerance.4 |