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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  
Name  Address 
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 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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 . 

 
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