INVESTIGATION OF THE EFFECT OF GUT BACTERIA ON MARKERS OF INFLAMMATION IN PATIENTS OF HIGH CHOLESTEROL WHO TAKING STATIN DRUGS AS TREATMENT

Not yet recruiting

• Registration Number: CTRI/2018/09/015689
• Lead Sponsor: ARDU RUHS College of Health Sciences Jaipur

Brief Summary

Hypercholesterolemia is an emerginghealth problem due to sedentary lifestyle. Mainly LDL cholesterol levels are increasein hypercholesterolemia that is a strong risk factor for cardiovasculardisease. The statins or HMG-CoA reductase inhibitorsare effective reduce LDL cholesterol levels as well as levels of inflammatorymarkers such as CRP, IL-6 and TNF-a. The human gastrointestinal system is populated with a variety ofsymbiotic organism namely, gut microbiota. Gut microbiota cause inflammationthat increases CVD risks.

In this study, we are using statintherapy as a treatment to reduce inflammation and tofind out effect of statin therapy on gut microbiota.

We will observe the association between gutmicrobiome and inflammation at different doses of statin. Secondly we will compare the effect ofhigh and low dose of statin on inflammatory markers.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-25
• Last Update Posted: 2018-11-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• 1.Confirmed cases of Hypercholesterolemia, defined as having the following: LDL >130 mg/dl, total cholesterol >200 mg/dl, HDL < 40 mg/dl according to National Cholesterol Education Program (NCEP) (Adult Panel Treatment III) guidelines for male subjec2.
• Presently not on Statin Therapy.

Exclusion Criteria

• Use of lipid-lowering drugs 2.
• Patients of Acute and Chronic infections 3.
• Overt Nephropathy 4.
• Use of antibiotics, antifungals, antivirals and antiparasitics drugs.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine association between gut microbiome and inflammation at different doses of statin.	12 weeks

Secondary Outcome Measures

Name	Time	Method
To compare the effect of high and low dose of statin on inflammatory markers.

Trial Locations

Locations (1)

Department of Biochemistry RUHS College of Medical Sciences, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Department of Biochemistry RUHS College of Medical Sciences, Jaipur

🇮🇳Jaipur, RAJASTHAN, India

Dr Priyanka Jain

Principal investigator

9460782342

priyanka_24feb@ymail.com