Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: T2DM patients aged 30-70 years where statin (atorvastatin or rosuvastatin) is indicated as per ADA - Standards of Medical Care in Diabetes, 2021 recommendations, 1. Statin naïve. 2. On statin for less than 3 months with baseline lipid profile available. 3. Prior history of statin intake, but currently not on statin for more than 6 months.
Exclusion criteria
Exclusion criteria: 1. Statin intolerance. 2. Contraindications to statins (hypersensitivity, active liver disease, unexplained persistent elevations of serum transaminase, pregnancy, breastfeeding). 3. Patients on lipid lowering agents other than statins. 4. Patients not willing for follow up. 5. Nephrotic syndrome, Cushing syndrome, overt hypothyroidism. 6. Concurrent use of anti-retroviral therapy, estrogens, oral contraceptive pills, retinoic acids, steroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Reduction in LDL and non-HDL subclasses from baseline, at 6 and/or 12 weeks of statin therapy in patients of Type 2 Diabetes mellitus.Timepoint: 6 and/or 12 weeks of statin therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Safety profile of statins. â?¢ Change in serum resistin levels at baseline and at 12 weeks with statin use in patients of Type 2 Diabetes mellitus.Timepoint: 6 and/or 12 weeks of statin therapy | — |
Countries
India
Contacts
All India Institute of Medical Sciences, Jodhpur