PEARL-DM: Efficacy of Empagliflozin and Pioglitazone in Diabetic Patients With NAFLD; Randomized Controlled Trial From Pakistan.

JSMU/IRB/2023/709

This clinical trial will yield results about the therapeutic effect of combining pioglitazone with SGLT2i in people suffering from NAFLD associated with T2DM. Study participants will be asked to fill out a few questions on proforma that will obtain demographic information as well as information relating to their health. In addition, some blood tests will be done following standard procedures.

2023-10-01

2024-04-01

2024-04-01

Not yet recruiting

Early phase I

240

Inclusion Criteria: * T2DM patients with NAFLD glycated * APRI scores of more than 1.5 Exclusion Criteria: * Patients having type 1 diabetes * evidence of advanced/decompensated cirrhosis (on the basis of a Child-Pugh score of more than 7 and MELD of more than 15) * hepatocellular carcinoma (evidence on ultrasound or alpha-fetoprotein) * patient suffering from acute or chronic hepatitis * biliary disease * HIV * hemochromatosis * autoimmune conditions (alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease) * renal dysfunction with GFR \[eGFR\] \<30 mL/min/1.73m2 * history of alcohol ( male \>30 g/d and female;20 g/d) * history of cancer or undergoing treatment for cancer, * use of amiodarone, tamoxifen, sodium valproate, corticosteroids, methotrexate, ursodeoxycholic acid, S-adenosyl methionine, betaine, silymarin, gemfibrozil * using supplements including vitamin E, vitamin C, zinc, and selenium or antioxidant agents over the last 3 months * history of cardiovascular events within the past 3 months * pregnancy or breastfeeding * contraindications to empagliflozin use (history of recurrent urogenital infections, current or previous gangrene, or hypersensitivity reaction to the molecule) * history of bladder cancer * morbid obesity (BMI greater than 35).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

2023-07-12