COMPARISON OF METFORMIN AND GLIMEPIRIDE IN PATIENTS OF COEXISTING TYPE 2 DIABETES MELLITUS AND NON ALCOHOLIC FATTY LIVER DISEASE

Phase 4

• Conditions: Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

• Registration Number: CTRI/2019/06/019926
• Lead Sponsor: nil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

1. Hypersensitivity to metformin, glimepiride and rosuvastatin.

2. Patients with age group < 20 years and > 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 ( <1

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified