A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)

Exclusion Criteria

• •Patients with active (acute or chronic) liver disease other than NASH (e.g. viral hepatitis, genetic hemochromatosis, Wilson disease, alpha 1antitripsin deficiency, alcohol liver disease, drug induced liver disease) at the time of randomization.
• •ALT or AST ≥ 2 times ULN
• •Abnormal synthetic liver function (serum albumin ≤3.5gm%, INR \>1.3).
• •Known alcohol and/or any other drug abuse or dependence in the last five years.
• •Weight \>120 Kg
• •Known history or presence of clinically significant cardiovascular, gastrointestinal, metabolic (other than diabetes mellitus), neurologic, pulmonary, endocrine, psychiatric, neoplastic disorder or nephrotic syndrome.
• •History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs including bile salt metabolites (e.g. inflammatory bowel disease (IBD), previous intestinal (ileal or colonic) operation, chronic pancreatitis, celiac disease or previous vagotomy.
• •Weight loss of more than 5% within 6 months prior to randomization.
• •History of bariatric surgery.
• •Uncontrolled blood pressure BP ≥150/95.
• •Non type 2 DM (type I, endocrinopathy, genetic syndromes etc).
• •Patients with HIV.
• •Daily alcohol intake \>20 g/day for women and \>30 g/day for men.
• •Treatment anti-diabetic medications other than metformin, such as DPP-4 inhibitors, GLP-1 receptor agonists, TZDs, etc.
• •Metformin, Fibrates, Statins, not provided on a stable dose in the last 6 months.
• •Patients who are treated with Valproic acid, Tamoxifen, Methotrexate, Amiodaron.
• •Chronic treatment with antibiotics (e.g. Rifaximin).
• •Homeopathic and/or Alternative treatments.
• •Uncontrolled hypothyroidism defined as Thyroid Stimulating Hormone \>2X the upper limit of normal (UNLN).
• •Patients with renal dysfunction: eGFR\< 40 ml/min.
• •Unexplained serum creatinine phosphokinase