A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine

Eligibility Criteria

• 1. Age 18-75 years
• 2. A clinical diagnosis of non-alcoholic fatty liver disease.
• 3. Alanine aminotransferase (ALT) levels ≥60 IU/mL
• 4. Laboratory tests as defined below:
• * Platelets \> 100,000/dL
• * Total bilirubin \< 2 mg/dL
• * Creatinine \< 1.6 mg/dL
• * Inclusion Criteria for Group 1: diabetic patients
• 1. At least one of the following:
• * Fasting blood sugar ≥ 126mg/dL
• * Hemoglobin A1c (HgA1c) of \> 6.5%
• * 2-hour plasma glucose level of \> 200mg/dL during a glucose tolerance test
• * Receiving treatment with insulin sensitizing drugs (metformin) or sulfonylureas (glipizide, etc.) 3. Inclusion Criteria for Group 2: Non-diabetic patients with insulin resistance (must have both)
• * Fasting blood glucose of 100-125 mg/dL and
• * Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score \>3.0
• 1. Evidence of liver disease other than non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
• 2. Alcohol consumption of more than 12g/d (1 drink) for females or more than 24g/day (2 drinks) for males, for 3 months during the past year
• 3. Active substance abuse within the past year
• 4. Prior or ongoing use of injectable insulin
• 5. Use of oral corticosteroids within the prior 30 days
• 6. Hospitalization within the past 14 days
• 7. Known HIV infection
• 8. HgA1c \>10%
• 9. Known heart failure of New York Heart Association class 2, 3, or 4
• 10. Any condition, which in the opinion of the investigator, would impede compliance or hinder the completion of the study
• 11. History of allergic reactions attributed to compounds of similar chemical or biologic composition to betaine
• 12. Current use of betaine or S-adenosylmethionine supplements, or refusal to abstain from their use during the study
• 13. Known cystathionine beta-synthase (CBS) deficiency.
• 14. Pregnancy or refusal to use birth control measures or breast feeding