Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Metformin and Rosuvastatin: Metformin (1 gm BD) and
Rosuvastatin (10 mg OD) for a duration of 3 months in patients of NAFLD concomitant with newly diagnosed Type 2 Diabetes Mellitus
C
Sponsors
nil
Eligibility
Inclusion criteria
Inclusion criteria: o NAFLD diagnosed by suggestive imaging findings (ultrasound) with abnormal aminotransferase levels. AST 50-150 U/L (1 to 3 times the upper limit of normal). o Concomitant with newly diagnosed T2DM. o Subjects between age group 20 â?? 60 years of either sex
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to metformin, glimepiride and rosuvastatin. 2. Patients with age group 60 years. 3. Patients with Type 1 Diabetes and Type 2 diabetes with end stage complications and diabetic ketoacidosis. 4. Pregnancy and lactation. 5. Patients with hypotensive states, thyroid disorders, adrenal insufficiency, heart failure, respiratory disorders tuberculosis, hepatobiliary disease, chronic renal disease. 6. Patients with hepatitis B & C and significantly deranged enzymes (ALT > 3 times normal values) 7. Patients with ascites, inflammatory bowel disease, malignancies, G6PD deficiency. 8. Patients on drugs causing hepatic steatosis. 9. Chronic drug or alcohol abuse (daily intake > 20g (2.5 units) in females and 30g (3.5 units) in males 10. Patients with comorbidities like microvascular complications, recent ( year) Myocardial infarction, acute coronary syndrome, stroke, osmotic symptoms, history of ketosis, weight loss of >3 kg in preceding 3 months. 11. Patients on drugs causing fatty liver changes like â?? amiodarone, methotrexate, tamoxifen, antiretroviral drugs, tetracyclines, acetaminophen & corticosteroids. 12. Patients on drugs like cimetidine, gemfibrozil, cyclosporine, digoxin, warfarin, beta blockers, calcium channel blockers, macrolide antibiotics, azole antifungals, cholestyramine, diazoxide, oestrogens, hydantoin, isoniazid, nicotinic acid, phenothiazines, rifampin, thiazide diuretics, urinary alkalinizers, furosemide. 13. Patients with megaloblastic anaemia, myopathy 14. Any trauma, surgery. 15. Patients refusing to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect on histological features of ultrasound liver in patients at the end of treatment Timepoint: 0 and 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect on Aminotransferase levels at the end of the treatmentTimepoint: 0,30,60,90 days | — |
Countries
India
Contacts
Public ContactDr Prabhsimran Kaur
Government Medical College , Amritsar
Outcome results
None listed