A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease

Study Overview
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Brief Summary
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Non Alcoholic Fatty Liver Disease (NAFLD) is considered as the component of metabolic syndrome. The prevalence of the same has been increasing rapidly in India, along with an increase in the prevalence of diabetes and obesity. Insulin resistance is the key underlying pathogenetic mechanism of NAFLD. NAFLD accounts for significant morbidity and mortality and the therapeutic options are limited. Insulin sensitizing drugs are used in the management of NAFLD.

Detailed Description
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The therapeutic options for the management of nonalcoholic fatty liver disease (NAFLD) include lifestyle modifications, insulin sensitizers, vitamin E, antioxidants and cytoprotective agents. Glitazones are insulin sensitizing drugs and act by stimulating the PPAR gamma receptors. The drugs like Pioglitazone and Rosiglitazone have shown conflicting results in the NAFLD trials. Dual PPAR stimulators (PPAR gamma and PPAR alfa) are known as the Glitazars and are useful in simultaneously controlling the hyperglycemia, dyslipidemia and insulin resistance. Saroglitazar is the first drug approved in the investigators country for the management of diabetic dyslipidemia. The investigators plan to study the efficacy of this drug in comparison to Pioglitazone in patients of NAFLD over a period of 24 weeks.

Official Title
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A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease (GLAZED Trial)

Conditions
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Fatty Liver

Intervention / Treatment
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* Drug: Saroglitazar
* Drug: Pioglitazone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Drug naive patients with NAFLD diagnosed on ultrasonography, BMI > 23 kg/m2 and ALT > 1.5 times the upper limit of normal Exclusion Criteria: Use of any drugs other than lifestyle modification for NAFLD, HbA1c > 8% FBS>200, Bilirubin > 1.5 mg/dL Any illness likely to cause transaminitis and positive viral markers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Saroglitazar Group<br>Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks | Drug: Saroglitazar<br>* Tab Saroglitazar 4 mg oral daily for 24 weeks<br>* Other names: Glitazar group;|
| Placebo Comparator: Pioglitazone Group<br>Tab Pioglitazone 30 mg daily fixed dose for 24 weeks | Drug: Pioglitazone<br>* Tab Pioglitazone 30 mg oral daily for 24 weeks<br>* Other names: Placebo Comparator group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the NAFLD fibrosis score |  | At baseline and the end of 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body composition |  | At baseline and the end of 24 weeks | 
| Change in insulin resistance |  | At baseline and the end of 24 weeks | 
| Change in lipid profile |  | At baseline and the end of 24 weeks | 
| Change in HbA1c |  | At baseline and the end of 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD, Diabetes, Glitazone