Paraoxonase-1 activity and effect of statins
- Conditions
- Health Condition 1: E785- Hyperlipidemia, unspecifiedHealth Condition 2: null- Statin Naive patients
- Registration Number
- CTRI/2017/08/009376
- Lead Sponsor
- Research Society Seth GSMC and KEM Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
1. Statin naïve patients aged between 18 -75 years of either gender, eligible for statin treatment as per the physicianâ??s diagnosis
2. Patient willing to give written informed consent
1. Patients having contraindication to statin like
a)Chronic renal failure or serum creatinine > 1.7 times the upper limit
b)Unexplained serum CK > 3 times the upper limit of normal Active hepatitis or cholestasis or ALT > 2 times the upper limit of normal.
c)Subjects taking one of the following medications and unable to maintain a stable dose at least four weeks prior to the screening visit and for the duration of the study: tamoxifen, raloxifene, estrogen and or progestins, thiazide diuretics, isotretinoin, Ã?-blockers, thyroid hormones, androgens, fiber supplements, protease inhibitors.
2. Patients requiring any other lipid lowering agent other than statins.
3. Patients having co-morbidities like any liver disease.
4. Pregnant and lactating women.
5. Inability to comply with the treatment and study protocol as per the investigatorâ??s judgment.
6. History of alcohol and substance abuse in last four weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the effect of statins on PON-1 activity across different allelic variantsTimepoint: 4 months
- Secondary Outcome Measures
Name Time Method To compare serum lipid levels before and after statin treatment and its correlation with PON-1 activityTimepoint: 4 months