The role of saroglitazar in the treatment of prediabetes and elevated lipid levels

Completed

Brief Summary: The preclinical and clinical studies of saroglitazar have suggested that saroglitazar is a potent triglyceride lowering agent along with significant improvement in insulin sensitivity. In various studies, saroglitazar has been found safe and well tolerated. The current study is designed to evaluate the effect of saroglitazar 4mg once daily in patients with prediabetes and dyslipidemia. This is an observational, single centre study. Subjects will be followed up for 24 weeks duration. Lipid (total cholesterol, triglycerides, VLDL-C, LDL-C, HDL-C and non HDL-C) and glycemic parameters (HbA1c) will be evaluated at baseline and at 24 weeks follo-up. Kidney and liver functions and ECG will also be done to evaluate the safety of saroglitazar.

Recruitment & Eligibility

Inclusion Criteria

Willing to participate in the study and follow protocol.
Patients of either sex with age group of 20-60 years.
Prediabetic patients with HbA1c 5.7- 6.5 % and deranged lipids as per NCEP guidelines.

Exclusion Criteria

Type 1 diabetes mellitus Type 2 diabetes Secondary hypertension.
Bronchial asthma.
Chronic obstructive pulmonary disease.
Any other respiratory disorders.
g.Any Hepatic or renal diseases.
h.Any other cardiovascular disorder.
ïƒ˜Pregnant and lactating women.
ïƒ˜History of known allergy to drugs.
ïƒ˜Patient concurrently taking other medication which is known to affect the blood sugar and lipid parameters.

Primary Outcome Measures

Name	Time	Method
Change in serum triglycerides	24 weeks

Secondary Outcome Measures

Name	Time	Method
change in HbA1c, total cholesterol, LDL-C, VLDL-C, non HDL-C, HDL-C	week 24

Locations (1): Deogiri Diabetes Centrer
🇮🇳
Aurangabad, MAHARASHTRA, India
Deogiri Diabetes Centrer
🇮🇳Aurangabad, MAHARASHTRA, India
Dr Deepak Bhosle
Principal investigator
7770087870
drdeepakbhosle@gmail.com