A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine
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
48 participants
Nov 12, 2013
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- Age 18-75 years
- A clinical diagnosis of non-alcoholic fatty liver disease.
- Alanine aminotransferase (ALT) levels ≥60 IU/mL
- Laboratory tests as defined below:
- Platelets \> 100,000/dL
- Total bilirubin \< 2 mg/dL
- Creatinine \< 1.6 mg/dL
- \. At least one of the following:
- Fasting blood sugar ≥ 126mg/dL
- Hemoglobin A1c (HgA1c) of \> 6.5%
- hour plasma glucose level of \> 200mg/dL during a glucose tolerance test
- Fasting blood glucose of 100-125 mg/dL and
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score \>3.0
Exclusion Criteria14
- Evidence of liver disease other than non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
- 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
- Active substance abuse within the past year
- Prior or ongoing use of injectable insulin
- Use of oral corticosteroids within the prior 30 days
- Hospitalization within the past 14 days
- Known HIV infection
- HgA1c \>10%
- Known heart failure of New York Heart Association class 2, 3, or 4
- Any condition, which in the opinion of the investigator, would impede compliance or hinder the completion of the study
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to betaine
- Current use of betaine or S-adenosylmethionine supplements, or refusal to abstain from their use during the study
- Known cystathionine beta-synthase (CBS) deficiency.
- Pregnancy or refusal to use birth control measures or breast feeding
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03073343