A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) and Elevated Alanine Aminotransferase (ALT)
Southern California Institute for Research and Education
Summary
Betaine (trimethyglycine) is a food supplement that is approved for sale in the United States without a prescription. In this study, betaine will be provided to patients as a powder that can be mixed with aqueous solutions and consumed orally.
Description
This is a prospective, unblinded, randomized study of oral betaine in diabetic and non-diabetic patients who have a clinical diagnosis of NAFLD and an ALT≥ 50 IU/mL. A clinical diagnosis of NAFLD is based on the presence of risk factors for NAFLD (such as overweight and insulin resistance) and the exclusion of other causes of liver disease, such as alcohol or viral hepatitis. Two cohorts of patients will be studied: Cohort 1 (diabetic) will consist of patients with a clinical diagnosis of non-insulin dependent type II diabetes mellitus; Cohort 2 (non-diabetics) will consist of patients withou…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Inclusion Criteria for all patients: 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 sens…
Interventions
- Dietary SupplementBetaine (trimethyglycine)
Betaine (trimethyglycine) is a food supplement that is approved for sale in the United States without a prescription. In this study, betaine will be provided to patients as a powder that can be mixed with aqueous solutions and consumed orally.
Location
- VA Long Beach Healthcare SystemLong Beach, California