Efficacy of Empagliflozin and Pioglitazone in Diabetic Patients With NAFLD

Jinnah Postgraduate Medical Centre

Status and phase: Not yet enrolling; Phase 4

Conditions: Type2diabetes; Non-Alcoholic Fatty Liver Disease

Treatments: Drug: Empagliflozin 10 MG; Drug: Pioglitazone 15mg; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT05942963

JSMU/IRB/2023/709

Details and patient eligibility

About

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.

Full description

This is a randomized clinical trial conducted to compare the efficacies of pioglitazone and empagliflozin in people suffering from NAFLD associated with T2DM.

Randomization will be done using card randomization. Four different color-coded cards will be kept. Any card will be randomly picked for the patient fulfilling inclusion criteria and will be treated according to the allocated treatment arm mentioned on the card

Written informed consent will be obtained from the immediate attendant of the patient. All ethical considerations will be followed.

Our research has been approved by Jinnah Sindh Medical University, Karachi. For this approval, the investigators have made every effort to ensure the confidentiality of research data collected from all our participants in this survey. The information collected will be stored with the investigators only in the form of de-identified information and will be retained in a secure place under lock and key. Any results that will be generated will be presented on a collective basis, and will not contain the participants name or any other personal details.

Data entry and analysis will be done using SPSS Software version 23. Study analysis will be done using the principle of intention to treat. The mean scores will be compared pre and post-intervention using paired t-test. The association of age, gender, and grade of fatty liver will be compared with different groups using correlation and regression models. All analyses will be at a confidence Interval of 95% and a p-value <.05.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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240 participants in 4 patient groups

Group A

Experimental group

Description:

SOC+ Empagliflozin + Pioglitazone

Treatment:

Drug: Empagliflozin 10 MG

Drug: Pioglitazone 15mg

Drug: Metformin

Group B

Experimental group

Description:

SOC +Empagliflozin

Treatment:

Drug: Empagliflozin 10 MG

Drug: Metformin

Group C

Experimental group

Description:

SOC+ Pioglitazone

Treatment:

Drug: Pioglitazone 15mg

Drug: Metformin

Group D

Active Comparator group

Description:

SOC only

Treatment:

Drug: Metformin