| CTRI Number |
CTRI/2025/09/094727 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Lipoprotein (a) and apolipoprotein B have been reported to be a better predictor of coronary artery disease than cholesterol indices among type 2 diabetes mellitus and healthy individuals |
|
Scientific Title of Study
|
Comparative analysis of extended lipid profile in type 2 Diabetes Mellitus and normoglycemic patients with and without CAD: a cross sectional study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankana Debnath |
| Designation |
DNB 1ST Year |
| Affiliation |
MEDANTA THE MEDICITY |
| Address |
Dept: biochemistry
upper ground floor
Medanta the Medicity Hospital
Gurugram, sector 38
Gurgaon
HARYANA
122001
India |
| Phone |
7005156004 |
| Fax |
|
| Email |
debnathankana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Charu Yadav |
| Designation |
Consultant |
| Affiliation |
MEDANTA THE MEDICITY |
| Address |
Dept :Biochemistry
upper ground floor
Medanta the Medicity
sector 38
Gurugram
Gurgaon
HARYANA
122001
India |
| Phone |
9739766824 |
| Fax |
|
| Email |
Charu.Yadav@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Ankana Debnath |
| Designation |
DNB 1ST Year |
| Affiliation |
MEDANTA THE MEDICITY |
| Address |
Dept: Biochemistry
upper ground floor
Medanta the Medicity
Sector 38
Gurugram
Gurgaon
HARYANA
122001
India |
| Phone |
7005156004 |
| Fax |
|
| Email |
debnathankana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medanta the Medicity
sector 38 , Gurugram |
|
|
Primary Sponsor
|
| Name |
Ankana Debnath |
| Address |
Medanta the Medicity
Sector 38 , Gurugram |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CHARU YADAV |
MEDANTA THE MEDICITY
GURGAO , HARYANA, 122001 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ANKANA DEBNATH |
Medanta the Medicity |
Dept : Biochemistry (path &lab Medicine )
Uper ground floor
Gurugram
Sector 38
Haryana, 122001
Gurgaon
HARYANA |
7005156004
debnathankana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Medanta institutional Ethics Committee |
Approved |
| Medanta institutional Ethics Committee |
Approved |
| Medanta institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, (2) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Type 2
Diabetes mellitus and normoglycemics as per the ADA
Diagnostic criteria shall be included
The above subjects shall be further grouped into with and without CAD based on history, ECG, stress Echo and Angiography findings.
|
|
| ExclusionCriteria |
| Details |
Known cases of chronic kidney diseases and nephrotic syndrome
Acute illness, recent hospitalization.
Chronic liver diseases, autoimmuno disorder, inflammatory condition.
Known cases of familial dyslipidemia on treatment other than statin such as
PCSK9 inhibitors, fibrates, ezetimibe drugs.
Pregnant women and lactation
Active malignancy
Severe hypothyroidism
Acute diabetes complications (DKA, HHS)
Other specific type of diabetes ( type 1 DM, MODY, LADA)
Smokers and chronic alcoholics
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of extended lipid profile [Lp(a), apoB, Total cholesterol,Triglycerides, LDL, HDL] in type 2 diabetes and normoglycemics with and without CAD.
|
1 year sept 2025 to sept 2026
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate Lp(a) & Apo B with glycemic indices & insulin
resistance.
|
1 year , sept 2025 to sept 2026 |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
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)
|
26/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/08/2026 |
| 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 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
|
Numerous risk factors like inflammatory pathology, insulin resistance, atherosclerosis predispose type 2 diabetes mellitus patients to an increased risk of coronary artery disease.This study is taken up to evaluate the utility of Lipoprotein(a) and apolipoprotein B as cardiovascular risk markers in type 2diabetes mellitus. |