| CTRI Number |
CTRI/2025/03/083746 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of biochemical markers of coronary artery disease in Type 2 diabetes mellitus patients |
|
Scientific Title of Study
|
Biochemical markers of coronary artery disease in Type 2 diabetes mellitus:a cross sectional study from Dehradun Uttrakhand |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1318-4662 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Richa Negi |
| Designation |
PhD research scholar |
| Affiliation |
SBSU Balawala Dehradun |
| Address |
SBSU Balawala Dehradun
School of life Sciences
Department of Biochemistry and Biotechnology.
Ekta vihar,lane no 1
Near Beverley hills Shalini school,Sahsradhara road.Dehradoon
Dehradun
UTTARANCHAL
248001
India |
| Phone |
07983633924 |
| Fax |
1352686286 |
| Email |
pundir.richa425@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Naudiyal |
| Designation |
Associate professor |
| Affiliation |
SBSU Balawala Dehradoon |
| Address |
SBSU Balawala Dehradun.
MLT Depertment
School of Allied Health Sciences
chamber no- 8
Dr Pooja Naudiyal
H.NO.23,Shreekunj Enclave
Navada Heights Lane,Near Nine Palms Wedding Point,Badripur
Jogiwala,Dehradun,Uttrakhand
Pin-248005
Dehradun
UTTARANCHAL
248001l
India |
| Phone |
9897298627 |
| Fax |
01352686286 |
| Email |
poojabamrara_2007@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Naudiyal |
| Designation |
Associate professor |
| Affiliation |
SBSU Balawala Dehradoon |
| Address |
SBSU Balawala Dehradoon
MLT Department
School of Allied Health Sciences
Chamber no-8
Dr. Pooja Naudiyal
H.NO 23,Shreekunj Enclave
Navada Heights Lane,Near Nine palms Wedding Point,Badripur
Jogiwala,Dehradoon,Uttrakhand
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9897298627 |
| Fax |
01352686286 |
| Email |
poojabamrara_2007@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Self-financed(Richa Negi)
India,Uttrakhand,Dehradoon
248001 |
|
|
Primary Sponsor
|
| Name |
Richa Negi |
| Address |
SBSU Balawala Dehradun
SBSU Balawala Dehradun. School of Life Sciences
Department of Biochemistry and Biotechnology |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr pooja Naudiyal |
synergy institute of medical sciences |
Department of Cardiology,room no 3 .Canal road,Ballupur chowk Ballupur dehradoon
Dehradun
UTTARANCHAL |
09897298627
1352226000
poojabamrara_2007@yahoo.co.in |
| Dr pooja Naudiyal |
SBSU Balawala Dehradoon,, |
SBSU Balawala Dehradoon
School of Life Sciences
Department of Biochemistry and Biotechnology
Dehradun
UTTARANCHAL |
09897298627
1352686286
poojabamrara_2007@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMTTEE UTTARANCHAL DENTAL AND MEDICAL RESEARCH INSTITUTE |
Approved |
| INSTITUTIONAL ETHICS COMMTTEE UTTARANCHAL DENTAL AND MEDICAL RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Type 2 Diabetes Diagnosis:
participant must be diagnosed with type 2 diabetes(confirmed by clinical criteria or medical records.
2.Age range:
studies may focus on specific age groups,such as adult aged 40-70 years,as CAD risk increases with age.
3.Presence of CAD or carddiovascular risk:
Participants should either have CAD (diagnosed through imaging or clinical signs)or be at high risk of devloping CAD,based on risk factor like high blood pressure,obesity,or smoking.
4.Measurement of Biochemical Markers:
.studies that measures specific biochemical markers associated with CAD markers(homocysteine,lipoprotein a,apolipoproteins
5.Study design:
cross sectional,observational study.
|
|
| ExclusionCriteria |
| Details |
1.Other type of Diabetes:
.Individual with type 1 diabetes, gestational diabetes, or other non-type 2 diabetes condition are excluded to focus on type 2 diabetes specifically.
2-Non cardiovascular disease:
participants with condition such as chronic kidney disease, liver dysfunction, cancer, or other major comorbidities that might confound the relationship between CAD and biochemical markers in type 2 diabetes.
3-Acute or uncontrolled illness:
Exclusion of individuals with acute infections, acute myocardial infarction, or other condition that might temporarily elevate biochemical markers unrelated to chronic CAD.
4-Pregnancy:
Pregnant women are typically excluded due to the physiological and hormonal changes during pregnancy that can affect biochemical markers and CAD risk.
5-Medication:
Individuals on certain medications(e.g,corticosteroids,high-dose statins, or immunosuppressive drugs)that might influence CAD markers in ways unrelated to the diabetes condition may be excluded.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Identication of specific biochemical markers associated with the presence or risk of Coronary artery disease in type 2 diabetes patients.
Lipid profile and glycemic control |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prevalance of Coronary artery disease in study population.
Association between clinical parameters & biochemical markers. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="524"
Sample Size from India="524"
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)
|
05/04/2025 |
| 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
|
This study aims to explore the biochemical markers associated with coronary artery disease(CAD) in individuals with type 2 diabetes in Dehradun. CAD is a common complication among type 2 diabetic patients due to the detrimental effect of chronic hyperglycemia and associated risk factors such as dyslipidemia, inflammation and oxidative stress. The study will be a Cross-sectional investigation, where biochemical markers will be measured in a sample of all four study groups.by examining these markers, the research will provide valuable insights into the specific biochemical alteration that predispose diabetic individual to CAD, with a particular focus on the unique metabolic profile of the population in Dehradoon.the output of this study could help in identifying early diagnostic biomarkers, improving risk prediction, and developing targeted therapeutic strategies for CAD in type 2 patients. |