| CTRI Number |
CTRI/2025/11/097950 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Serum Ceruloplasmin Levels and Triglyceride/HDL-C Ratio in Diabetic Retinopathy Patients |
|
Scientific Title of Study
|
Evaluation of Serum Ceruloplasmin and Triglyceride/HDL-C ratio in Patients with Diabetic Retinopathy |
| 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 Swarna Paliwal |
| Designation |
PG Resident |
| Affiliation |
RUHS college of medical sciences,jaipur |
| Address |
RUHS college of medical sciences,jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
7877725058 |
| Fax |
|
| Email |
doc.swarnapaliwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Ahuja |
| Designation |
Professor |
| Affiliation |
RUHS college of medical sciences,jaipur |
| Address |
Department of biochemistry,RUHS college of medical sciences,sector 11, kumbha marg,pratap nagar,jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
7877725058 |
| Fax |
|
| Email |
drjitendraahuja@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jitendra Ahuja |
| Designation |
Professor |
| Affiliation |
RUHS college of medical sciences,jaipur |
| Address |
Department of biochemistry,RUHS college of medical sciences,sector 11,kumbha marg,pratap nagar,jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
7877725058 |
| Fax |
|
| Email |
drjitendraahuja@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| RUHS college of medical sciences ,sector 11,kumbha marg,pratap nagar,jaipur,302033,India |
|
|
Primary Sponsor
|
| Name |
Dr Swarna Paliwal |
| Address |
Resident hostel,RUHS college of medical sciences,sector 11,kumbha marg,pratap nagar,jaipur,302033,India |
| 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 Swarna Paliwal |
RUHS college of medical sciences ,jaipur and associated hospitals,jaipur |
Department of biochemistry,RUHS college of medical sciences,jaipur
Jaipur
RAJASTHAN |
7877725058
doc.swarnapaliwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHS-CMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H356||Retinal hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patient confirmed with type 2 diabetes mellitus |
|
| ExclusionCriteria |
| Details |
1. Patient having retinopathy other than DR
2. Use of medications that could influence serum ceruloplasmin levels or lipid profiles, such as corticosteroids or lipid-lowering agents.
3. Patient with coexisting diabetic nephropathy
4. Patients with history of recent surgery/trauma/infection/inflammation
5.Patient with severe hepatic/renal diseases
6.Pregnant or breastfeeding women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the serum ceruloplasmin levels and TG/HDL-C ratio in type 2 Diabetes Mellitus (DM) patients without DR, type 2 DM with DR and age- and sex-matched non-diabetic controls |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To analyse the differences in serum ceruloplasmin levels & TG/HDL-C ratio among non-diabetic controls, diabetic patients without DR, diabetic patients with DR
2.To perform receiver operating characteristic (ROC) curve analysis for evaluating the discriminative power of serum ceruloplasmin levels & TG/HDL-C ratio in non-diabetic controls, diabetic patients without DR & diabetic patients with DR.
|
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
15/12/2025 |
| 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="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
|
PROJECT SUMMARY
Title of the Study: Evaluation of Serum Ceruloplasmin and
Triglyceride/HDL-C Ratio in Patients with Diabetic Retinopathy
- This study will be done to evaluate the potential roles of serum
ceruloplasmin levels and the triglyceride/high-density lipoprotein cholesterol
(TG/HDL-C) ratio in patients with diabetic retinopathy (DR).
- The study will be conducted in the Department of Biochemistry, in
collaboration with the Department of Medicine and Department of
Ophthalmology, at RUHS College of Medical Sciences (RUHS-CMS) and
associated hospitals in Jaipur.
- Study Type: Cross-sectional comparative study.
- Study Duration: 1 year.
ยท
Study
universe: 20 DR patients out of around 40 DR patients
from an average of 95-100 DM patients
attending one medicine OPD at Department of Medicine, associated hospital
RUHS-CMS, Jaipur per month
- Age Group: 30 to 70 years of age, both male and female
participants.
- Study Groups:
- Group 1: 60 T2DM patients diagnosed with diabetic
retinopathy (any sign of DR such as microaneurysm, dot blot hemorrhages,
venous bleeding, or neovascularization).
- Group 2: 60 T2DM patients without diabetic
retinopathy.
- Group 3: 60 healthy individuals without diabetes
(age and sex-matched controls).
- Sample Size: 180 participants (60 from each group).
- The primary aim of this study is to investigate the relationship
between serum ceruloplasmin levels, TG/HDL-C ratio, and the presence and
severity of diabetic retinopathy in Type 2 DM patients.
- By identifying individuals at risk for DR, early intervention
strategies can be employed to prevent or slow the progression of the
disease, thus preserving vision and improving the quality of life for
diabetic patients.
|