Overview

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

Status:
Unknown status
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Command Hospital, India
Treatments:
Pioglitazone
Criteria
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