Fatty Liver
Conditions
Keywords
NAFLD, Diabetes, Glitazone
Brief summary
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
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.
Interventions
DRUGSaroglitazar
Tab Saroglitazar 4 mg oral daily for 24 weeks
DRUGPioglitazone
Tab Pioglitazone 30 mg oral daily for 24 weeks
Sponsors
Command Hospital, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the NAFLD fibrosis score | At baseline and the end of 24 weeks |
Secondary
| Measure | 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 |
Countries
India
Contacts
Primary ContactHari Kumar, MD
Outcome results
None listed