Comparison the treatment effect of Pioglithazone with Metformin in patients with Non Alcoholic SteatoHepatitis (NASH)

Comparing the treatment effect of Pioglitazone with Metformin in patients with Non Alcoholic SteatoHepatitis (NASH)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201105026361N1

Enrollment

Registered

2011-11-16

Start date

2011-03-06

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty liver. fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Metformin: Tablet 500 mg, oral, BID, for 4 months. Intervention 2: Pioglitazone: Tablet 30 mg, oral, daily, for 4 months.

Treatment - Drugs

Metformin: Tablet 500 mg, oral, BID, for 4 months.

Pioglitazone: Tablet 30 mg, oral, daily, for 4 months

Eligibility

Sex/Gender

All

Age

21 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: All patients with fatty liver disease based on sonography that have Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) more than normal (more than 40). Exclusion criteria: Alcohol consumption; drug induced hepatitis; use of some drugs (corticosteroids, statins); Diabetes mellitus; Chronic viral hepatitis (B,C); Autoimmune hepatitis; Wilson disease; Hemochromatosis; Ischemic heart disease; Heart failure; Liver failure; liver mass; Pregnancy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
FBS. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;TG. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;Chlo. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;HDL. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;LDL. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;AST. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;ALT. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;Alkp. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;Body weight. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Balance.;HOMA Index. Timepoint: Before intervention and end of intervention (four months after intervention). Method of measurement: fasting Glucose(mmol/L)*Insulin(microunit/ml)/22.5.;Serum Adiponectin. Timepoint: Before intervention and end of intervention (four months after intervention). Method of measurement: Enzyme Linked Immunosorbent Assay (ELISA).	—

Measure

Time frame

FBS. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;TG. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;Chlo. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;HDL. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;LDL. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;AST. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;ALT. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;Alkp. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Device photometry.;Body weight. Timepoint: Before intervention, two months after intervention and end of intervention (four months after intervention). Method of measurement: Balance.;HOMA Index. Timepoint: Before intervention and end of intervention (four months after intervention). Method of measurement: fasting Glucose(mmol/L)*Insulin(microunit/ml)/22.5.;Serum Adiponectin. Timepoint: Before intervention and end of intervention (four months after intervention). Method of measurement: Enzyme Linked Immunosorbent Assay (ELISA).

—

Secondary

Measure	Time frame
Side effects of drug. Timepoint: before intervention, two months after intervention, end of intervention (four months after intervention). Method of measurement: history, physical examination, plasma sampling.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seied Mohsen Razavizadeh

Kashan University of Medical Sciences and Health Services

razavizadeh_m@kaums.ac.ir , mohsen-razavizade@yahoo.com+98 36 1555 0026

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026