CTRI/2022/10/046795Not yet recruitingNot Applicable
Study on antidyslipidemic and insulin sensitising effects of saroglitazar in patients with diabetic dyslipidemia
maulana azad medical college1 site in 1 country40 target enrollmentStarted: January 11, 2022Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- maulana azad medical college
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To study the effects of Saroglitazar on
Study Overview
Brief Summary
Saroglitazar is a Dual PPAR agonist approved for use in treatment of diabetic dyslipidemia
animal model studies indicated that saroglitazar has a role in improving insulin sensitivity
we are going to see the effect of saroglitazar in terms if insulin sensitivity (by neasurement of HOMA-IR) and lipid profile in patients of Diabetic dyslipidemia with low dose statins
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with diabetic dyslipidemia with fasting triglycerides > 200-400 who are being treated with any of non insulin secretogogues( alpha glucose daze inhibitors, biguanides, SGLT-2 inhibitors) and low dose statin for at least 3 months.
Exclusion Criteria
- •patients on insulin, glitazar, glitazone, insulin secretogagues (sulfonylureas) history of Thyroid disease, cardiac illness, liver disease (s.bilirubin > 2 times Upper normal limits), renal dysfunction(s.creatinine > 1.2mg/dL) comorbid serious illness like tuberculosis, malignancy, HIV.
- •Pregnant and nursing mother.
Outcomes
Primary Outcomes
To study the effects of Saroglitazar on
Time Frame: 0 and 84th day after drug intake
1. Insulin Resistance
Time Frame: 0 and 84th day after drug intake
2. Lipid profile
Time Frame: 0 and 84th day after drug intake
in patients with Diabetic Dyslipidemia
Time Frame: 0 and 84th day after drug intake
Secondary Outcomes
- study the effects of Saroglitazar on(1.HbA1c levels)
Investigators
Study Sites (1)
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