| CTRI Number |
CTRI/2026/01/100968 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying how cholesterol problems are related to kidney damage in people with type 2 diabetes |
|
Scientific Title of Study
|
Correlation of apolipoprotien B and dyslipidemia with protienuria in type 2 diabetes mellitus patient. |
| 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 Manish chandey |
| Designation |
Professor |
| Affiliation |
Sri Guru Ram das institute of medical sciences and research |
| Address |
House number 260 A , medical enclave circular road
Amritsar
punjab
india
Amritsar
PUNJAB
143001
India |
| Phone |
9872071231 |
| Fax |
|
| Email |
chandey96098@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish chandey |
| Designation |
Professor |
| Affiliation |
Sri Guru Ram das institute of medical sciences and research |
| Address |
House no 260 A , medical enclave circular road
Amritsar
punjab
india
Amritsar
PUNJAB
143001
India |
| Phone |
9872071231 |
| Fax |
|
| Email |
chandey96098@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Arshdeep kaur saggi |
| Designation |
Junior resident |
| Affiliation |
Sri Guru Ram das institute of medical sciences and research |
| Address |
House no 225,guru amar dass nagar near verka milk plant ,
Jalandhar
Punjab
India
Jalandhar
PUNJAB
144001
India |
| Phone |
9872834568 |
| Fax |
|
| Email |
saggiarshdeep@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of medicine |
| Address |
Shri guru Ram das institute of medical sciences and research ,vallah,amritsar,punjab |
| 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 |
| Arshdeep Kaur Saggi |
Shri guru Ram das institute of medical sciences and research |
Department of medicine ,3rd floor
,Amritsar
Punjab
Amritsar
PUNJAB |
9872834568
saggiarshdeep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patient with type 2 diabetes mellitus diagnosed with ADA 2025 guidelines |
|
| ExclusionCriteria |
| Details |
Age below 18 years.
Type 2 Diabetes Mellitus patients with concomitant diseases or conditions affecting the lipid levels such as-Hypothyroidism , Familial dyslipidemia, familial hypercholesterolemia, alcoholics to avoid false increase in apolipoproteins.
patient with Active liver disease
patients on dialysis
patients on lipid lowering drugs within 6 weeks and weight reducing diet
pregnant and lactating female patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study found that higher ApoB levels and atherogenic dyslipidemia are significantly associated with increased proteinuria in Type 2 Diabetes Mellitus patients. ApoB showed a stronger correlation with proteinuria than traditional lipid parameters, indicating it may be a better marker of early kidney involvement in diabetic patients |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
24/01/2026 |
| 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="1"
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
|
Proteinuria is an early indicator of diabetic kidney damage in Type 2 Diabetes Mellitus. Apolipoprotein B (ApoB) is a key structural component of atherogenic lipoproteins, and many diabetic patients develop dyslipidemia, which may contribute to renal injury. This study explores how ApoB levels and patterns of dyslipidemia correlate with the presence and severity of proteinuria. Higher ApoB and abnormal lipid profiles (high LDL, high triglycerides, low HDL) are significantly associated with increased proteinuria. This suggests that ApoB may serve as a useful marker for early detection of diabetic nephropathy and highlights the importance of lipid control in preventing kidney complications in Type 2 diabete |