Evaluation of heart disease risk in type 2 Diabetes Mellitus patients using FRS, Q-RISK3, INTERHEART Risk Scores & their correlation with lipoprotein (a) level.

Not yet recruiting

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2022/08/044536

Lead Sponsor: Dr Ramesh Kumar Chandak

Brief Summary: Cardiovasculardiseases (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 themajor cause of death for those with diabetes, accounting for about 70% of alldeaths in the patient population.

Lipoprotein (a)is a low-density lipoprotein (LDL) particle with the glycoprotein apo(a) covalentlybound to apo B-100. Apo(a) is a highly glycosylated hydrophilic apolipoproteinwhich is synthesized by the liver. Apo(a) is structurally homologous to theplasma protein plasminogen which is involved in the lysis of clots.Strong evidence in epidemiological, genetic, and prospective cohort studiesverified that circulating lp(a) levels were associated with the presence ofcardiovascular disease (CVD). Lipoprotein (a) is an emergingcardiovascular risk factor which is also associated with diabetes.

In the presentstudy CVD risk in type 2 diabetes will be assessed and categorized into thoseat low, moderate, and high CVD risk bycalculating various risk scores methods that are: 17

(1) FRAMINGHAMRISK SCORE

(2) QRISK3

(3) INTERHEARTRISK SCORE

Hospital basedcross sectional study will be carried out in Department of Biochemistry of RUHSCollege of Medical Sciences & associated hospital, Jaipur, over a period of1.5 years. 90 participants of either gender with type 2 DM will be recruited attendingmedicine OPD and IPD after writteninformed consent and ethics approval from the institutional ethics committee. normal distribution=1.96, absoluteprecision =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 .

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 89

Inclusion Criteria

With or Without Microvascular Complications of type 2 DM.

Exclusion Criteria

1Previous history of CVD.
2Patients with macrovascular complications of diabetes.
3Terminally ill.
4Severe liver and renal insufficiency.
5Type 1 DM 6Cancer.
7Thyroid dysfunctions.
8Severe mental illness.
9Pregnancy.
10Peripheral artery disease.
11Hemolytic disease.
12Fever & goiter.
13Sleep apnea syndrome.
14Severe disabilities.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
to assess lipoprotein a and compare anthropometric parameters in type 2 DM patients	3 months

Trial Locations

Locations (1): RUHS College of Medical Sciences
🇮🇳
Jaipur, RAJASTHAN, India
RUHS College of Medical Sciences
🇮🇳Jaipur, RAJASTHAN, India
Dr Ramesh Kumar Chandak
Principal investigator
9887799225
rameshchandak25@gmail.com