Mechanisms of action of hypoglycemic drugs in nonalcoholic fatty liver disease (NAFLD)

Mechanisms of action of hypoglycemic drugs in nonalcoholic fatty liver disease (NAFLD): elucidation of its association with 'inflammation'

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33414972

Enrollment

800

Registered

2013-12-16

Start date

2010-08-01

Completion date

Unknown

Last updated

2017-02-27

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

Conditions

Nonalcoholic fatty liver disease, type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

Patients are divided into NAFLD and non-NAFLD groups by abdominal ultrasound. The patients with NAFLD will be then randomly allocated to receive either pioglitazone (30 mg/day), metformin (1 g/day),

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Diabetic males aged 40-70 years 2. Previously untreated for type 2 diabetes (T2DM) 3. Body mass index (BMI) >25 kg/m2 4. Glycated hemoglobin (HbA1c) of 6.4-7.9% (National Glycohemoglobin Standardization Program units) 5. Fasting plasma glucose of 126-261 mg/dl

Exclusion criteria

Exclusion criteria: 1. Patients with mental disorders, including alcohol dependence, or with such a history 2. Patients with pancreatitis 3. Patients with malignant diseases 4. Patients with viral hepatitis 5. Patients who have participated in any clinical study or trial within 6 months 6. Patients experiencing a weight gain or loss of 1 kg or more within 3 months before the start of the trial 7. Patients deemed ineligible for the trial

Design outcomes

Primary

Measure	Time frame
Differences between baseline and end-of-treatment liver to spleen (L/S) ratios determined by CT and physical findings (blood pressure, body mass index and waist circumference) will be measured in each group. Blood samples will be obtained to measure concentrations of aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT), cholinesterase, fasting plasma glucose, fasting insulin, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol (HDL-C), triglycerides, non-esterified fatty acids (NEFA), high-sensitivity C-reactive protein (hsCRP), soluble tumor necrosis factor receptors 1 (sTNFR-1), and 2 (sTNFR-2), high-molecular-weight (HMW) adiponectin, and ferritin.	—

Measure

Time frame

Differences between baseline and end-of-treatment liver to spleen (L/S) ratios determined by CT and physical findings (blood pressure, body mass index and waist circumference) will be measured in each group. Blood samples will be obtained to measure concentrations of aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT), cholinesterase, fasting plasma glucose, fasting insulin, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol (HDL-C), triglycerides, non-esterified fatty acids (NEFA), high-sensitivity C-reactive protein (hsCRP), soluble tumor necrosis factor receptors 1 (sTNFR-1), and 2 (sTNFR-2), high-molecular-weight (HMW) adiponectin, and ferritin.

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Japan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 11, 2026