CTRI Number |
CTRI/2022/08/044536 [Registered on: 01/08/2022] Trial Registered Prospectively |
Last Modified On: |
09/07/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Evaluation of heart disease risk in type 2 Diabetes Mellitus patients using FRS, Q-RISK3, INTERHEART Risk Scores & their correlation with lipoprotein (a) level. |
Scientific Title of Study
|
Evaluation of cardiovascular disease risk in type 2 diabetes mellitus patients using framingham risk score, qrisk3, interheart risk scores and their correlation with lipoprotein (a) level. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ramesh kumar Chandak |
Designation |
Resident |
Affiliation |
RUHS-CMS |
Address |
Department of Biochemistry, RUHS-CMS, Pratap Nagar, Jaipur Room no 406, Resident Hostel RUHS-CMS, Pratap Nagar, Jaipur Jaipur RAJASTHAN 302033 India |
Phone |
9887799225 |
Fax |
|
Email |
rameshchandak25@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sonali Sharma |
Designation |
Senior Professor |
Affiliation |
RUHS-CMS |
Address |
Department of Biochemistry, RUHS-CMS, Jaipur
Jaipur RAJASTHAN 302033 India |
Phone |
9414314678 |
Fax |
|
Email |
sonalisharma14@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sonali Sharma |
Designation |
Senior Professor |
Affiliation |
RUHS-CMS |
Address |
Department of Biochemistry, RUHS-CMS, Jaipur
Jaipur RAJASTHAN 302033 India |
Phone |
9414314678 |
Fax |
|
Email |
sonalisharma14@gmail.com |
|
Source of Monetary or Material Support
|
Department of Biochemistry RUHS-CMS Associated RDBP Jaipuriya Hospital |
|
Primary Sponsor
|
Name |
Dr Ramesh Kumar Chandak |
Address |
RUHS-CMS, Pratap Nagar, Jaipur |
Type of Sponsor |
Other [] |
|
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 Ramesh Kumar Chandak |
RUHS College of Medical Sciences |
Biochemistry Department Second Floor, Sector 11, kumbha marg, Jaipur RAJASTHAN |
9887799225
rameshchandak25@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
RUHS-CMS ETHICS COMMITEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
With or Without Microvascular Complications of type 2 DM
|
|
ExclusionCriteria |
Details |
1 Previous history of CVD.
2 Patients with macrovascular complications of diabetes.
3 Terminally ill.
4 Severe liver and renal insufficiency.
5 Type 1 DM
6 Cancer.
7 Thyroid dysfunctions.
8 Severe mental illness.
9 Pregnancy.
10 Peripheral artery disease.
11 Hemolytic disease.
12 Fever & goiter.
13 Sleep apnea syndrome.
14 Severe disabilities.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To assess CVD risk in patients of type 2 Diabetes mellitus using various risk scores- FRS,Q RISK 3 ,and Interheart risk score. |
6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
to assess lipoprotein a and compare anthropometric parameters in type 2 DM patients |
3 months |
|
Target Sample Size
|
Total Sample Size="89" Sample Size from India="89"
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)
|
08/08/2022 |
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="9" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Cardiovascular
diseases (CVDs) are the single leading cause of death globally.Diabetes elevates the risk for cardiovascular disease (CVD) complications,
particularly atherosclerotic vascular disease. Cardiovascular events remain the
major cause of death for those with diabetes, accounting for about 70% of all
deaths in the patient population.
Lipoprotein (a)
is a low-density lipoprotein (LDL) particle with the glycoprotein apo(a) covalently
bound to apo B-100. Apo(a) is a highly glycosylated hydrophilic apolipoprotein
which is synthesized by the liver. Apo(a) is structurally homologous to the
plasma protein plasminogen which is involved in the lysis of clots.Strong evidence in epidemiological, genetic, and prospective cohort studies
verified that circulating lp(a) levels were associated with the presence of
cardiovascular disease (CVD). Lipoprotein (a) is an emerging
cardiovascular risk factor which is also associated with diabetes. In the present
study CVD risk in type 2 diabetes will be assessed and categorized into those
at low, moderate, and high CVD risk by
calculating various risk scores methods that are: 17
(1) FRAMINGHAM
RISK SCORE
(2) QRISK3
(3) INTERHEART
RISK SCORE Hospital based
cross sectional study will be carried out in Department of Biochemistry of RUHS
College of Medical Sciences & associated hospital, Jaipur, over a period of
1.5 years. 90 participants of either gender with type 2 DM will be recruited attending
medicine OPD and IPD after written
informed consent and ethics approval from the institutional ethics committee. normal distribution=1.96, absolute
precision =9% prevalence =25% so so sample size will be taken approximate 90. and in this study patients will be included 30 to 70 years age of either gender of type 2 diabetes mellitus . |