| CTRI Number |
CTRI/2026/03/105332 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The link between iron, inflammation, and small blood vessel damage in type 2 diabetes |
|
Scientific Title of Study
|
Correlation of serum ferritin, and highly sensitive c reactive protein with microvascular complications in cases of type ii 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 |
Abhishek Garg |
| Designation |
Junior Resident |
| Affiliation |
Datta meghe institute of higher education and research |
| Address |
Department of medicine, avbrh, jnmc, sawangi, wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9991978449 |
| Fax |
|
| Email |
gargckd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuj Varma |
| Designation |
Professor, Department of medicine, avbrh, jnmc, sawangi, wardha |
| Affiliation |
Datta meghe institute of higher education and research |
| Address |
Department of medicine, avbrh, jnmc, sawangi, wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860500065 |
| Fax |
|
| Email |
anujvarma1985@gmail,com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuj Varma |
| Designation |
Professor, Department of medicine, avbrh, jnmc, sawangi, wardha |
| Affiliation |
Datta meghe institute of higher education and research |
| Address |
Department of medicine, avbrh, jnmc, sawangi, wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860500065 |
| Fax |
|
| Email |
anujvarma1985@gmail,com |
|
|
Source of Monetary or Material Support
|
| Datta meghe institute of higher education and research |
|
|
Primary Sponsor
|
| Name |
Datta meghe institute of higher education and research |
| Address |
Sawangi Meghe, Wardha, India 442001 |
| Type of Sponsor |
Private 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 Anuj Varma |
JNMC |
Datta meghe institute of higher education and research, sawangi, wardha
Wardha
MAHARASHTRA |
9860500065
gargckd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Diagnosed T2DM (per ADA guidelines).
2 Age between 18 to 70 years.
2 Informed consent provided. |
|
| ExclusionCriteria |
| Details |
1 Acute infections, chronic inflammatory conditions.
2 Known iron metabolism disorders or iron supplementation.
3 Chronic liver disease, malignancies, or hematological disorders.
4 Type 1 or gestational diabetes.
5 Recent surgeries or trauma (within last 3 months). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum ferritin and highly sensitive c reactive protein can be used as prognostic marker for microvascular complications in cases of type ii diabetes mellitus |
at baseline, after completion of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
18/03/2026 |
| 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="2"
Months="6"
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 study aims to provide insights into the relationship between inflammation, iron metabolism, and microvascular complications in T2DM. Identification of reliable biomarkers like serum ferritin and hs-CRP may facilitate early detection and risk stratification of diabetic complications, beyond glycemic control measures alone. Incorporating these parameters in routine clinical assessment could lead to personalized preventive and therapeutic strategies, potentially reducing the burden of diabetes-related complications. |