COMPARATIVE EVALUATION OF EFFICACY AND SAFETY OF METFORMIN AND GLIMEPIRIDE WITH CONCOMITANT ROSUVASTATIN IN PATIENTS OF NON ALCOHOLIC FATTY LIVER DISEASE WITH COEXISTENT TYPE 2 DIABETES MELLITUS
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect on histological features of ultrasound liver in patients at the end of treatment
研究概览
简要总结
Non alcoholic fatty liver disease (NAFLD) is a rising health concern andis strongly associated with Type 2 Diabetes mellitus (T2DM) with insulinresistance being the pivotal feature between the two. The prevalence of NAFLDis 59.67% in T2DM. NAFLD includes pathological ectopic fat deposition alongwith low grade chronic inflammatory state in the liver cells. No specific therapyis yet approved for coexisting NAFLD & T2DM and fewer studies have beendone to assess the efficacy and safety of metformin and glimepiride in it. Thepresent study aims to compare the efficacy and safety of metformin andglimepiride with concomitant rosuvastatin in patients of NAFLD coexistent withT2DM. It will be interventional, randomized, prospective, parallel, open-labeland intention to treat study of 12 weeks. It will comprise of 60 patients of eithersex (20- 60 years) from Department of Medicine, Guru Nanak Dev Hospital,attached to Government Medical College, Amritsar. Patients will be randomlydivided into two groups- A & B of thirty each. Group A will be prescribedmetformin 1 gm BD and rosuvastatin 10 mg OD. Group B will be prescribedglimepiride 3 mg BD and rosuvastatin 10 mg OD. Follow up will be done every15 days for 12 weeks and will undergo assessment of anthropometricparameters, liver function tests, renal function tests, lipid profile, fasting bloodsugar, HbA1c, insulin resistance and ultrasound of liver. Data will be tabulatedand analyzed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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 – 60 years of either sex.
排除标准
- •Hypersensitivity to metformin, glimepiride and rosuvastatin.
- •Patients with age group < 20 years and > 60 years.
- •Patients with Type 1 Diabetes and Type 2 diabetes with end stage complications and diabetic ketoacidosis.
- •Pregnancy and lactation.
- •Patients with hypotensive states, thyroid disorders, adrenal insufficiency, heart failure, respiratory disorders tuberculosis, hepatobiliary disease, chronic renal disease.
- •Patients with hepatitis B & C and significantly deranged enzymes (ALT> 3 times normal values)
- •Patients with ascites, inflammatory bowel disease, malignancies, G6PD deficiency.
- •Patients on drugs causing hepatic steatosis.
- •Chronic drug or alcohol abuse (daily intake > 20g (2.5 units) in females and 30g (3.5 units) in males
- •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.
- •Patients on drugs causing fatty liver changes like – amiodarone, methotrexate, tamoxifen, antiretroviral drugs, tetracyclines, acetaminophen & corticosteroids.
- •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.
- •Patients with megaloblastic anaemia, myopathy
- •Any trauma, surgery.
- •Patients refusing to give informed consent.
结局指标
主要结局
Effect on histological features of ultrasound liver in patients at the end of treatment
时间窗: 0 and 90 days
次要结局
- Effect on Aminotransferase levels at the end of the treatment(0,30,60,90 days)