Effect of saroglitazar on vascular function in patients with type 2 diabetes
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2020/06/025946
- Lead Sponsor
- JIPMER Intramural Research Grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
Patients with type 2 diabetes mellitus diagnosed by American Diabetes Association (ADA) criteria within the past 3 months to 10 years, on stable dose of metformin with or without sulfonylureas, for at least past 2 months, with HbA1C of 7.5-9%
1) Liver dysfunction (AST,ALT > 2 times the upper limit of normal)
2) Renal dysfunction (GFR <60 ml/min/1.73 m2)
3) Patient with concurrent illnesses like CAD(Coronary Artery Disease), CVA( cerebrovascular accidents), PVD(Peripheral Vascular Disease), CKD( Chronic Kidney Disease)other than hypertension
4) Patients taking anti diabetic drugs other than metformin and sulfonylureas
5) Pregnant women or lactating mothers; women in reproductive age group not practicing contraceptive measures.
6) Patients who had participated in other trials in the past three months.
7) Patients with active infections such as diabetic foot infection etc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Carotid femoral pulse wave velocityTimepoint: Carotid femoral pulse wave velocity at baseline, 1st, 2nd, and 3rd months
- Secondary Outcome Measures
Name Time Method 1. s-ICAM, S-VCAM, E-selectin, interleukin-6 <br/ ><br>2.Lipid profile <br/ ><br>3. Adverse drug reactions to saroglitazarTimepoint: 1. s-ICAM, S-VCAM, E-selectin, interleukin-6 at baseline and 3 months <br/ ><br>2.Lipid profile at baseline and 3 months <br/ ><br>3. Adverse drug reactions to saroglitazar at baseline, 1st, 2nd, 3rd months