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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saroglitazar Group | Active Comparator | Tab Saroglitazar 4 mg oral daily fixed dose for 24 weeks |
|
| Pioglitazone Group | Placebo Comparator | Tab Pioglitazone 30 mg daily fixed dose for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saroglitazar | Drug | Tab Saroglitazar 4 mg oral daily for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the NAFLD fibrosis score | At baseline and the end of 24 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hari Kumar, MD | Contact | 00918146141700 | hariendo@rediffmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hari Kumar, MD | Command Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Command Hospital | Recruiting | Panchkula | Haryana | 134107 | India |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000588741 | saroglitazar |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Pioglitazone | Drug | Tab Pioglitazone 30 mg oral daily for 24 weeks |
|
|
| At baseline and the end of 24 weeks |
| Change in HbA1c | At baseline and the end of 24 weeks |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |