Actively Recruiting
A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine
Led by Southern California Institute for Research and Education · Updated on 2024-05-07
48
Participants Needed
1
Research Sites
633 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Clinical diagnosis of non-alcoholic fatty liver disease
- Alanine aminotransferase (ALT) level of at least 60 IU/mL
- Platelet count greater than 100,000/dL
- Total bilirubin less than 2 mg/dL
- Creatinine less than 1.6 mg/dL
- For diabetic patients: at least one of the following: fasting blood sugar ≥ 126 mg/dL, hemoglobin A1c > 6.5%, 2-hour plasma glucose > 200 mg/dL during glucose tolerance test, or treatment with insulin sensitizing drugs or sulfonylureas
- For non-diabetic patients: fasting blood glucose between 100-125 mg/dL and HOMA-IR score greater than 3.0
You will not qualify if you...
- Liver disease other than non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
- Alcohol use over 12g/day for females or over 24g/day for males in the past year for 3 months
- Substance abuse within the past year
- Prior or current use of injectable insulin
- Use of oral corticosteroids in the past 30 days
- Hospitalization within the past 14 days
- Known HIV infection
- Hemoglobin A1c over 10%
- Heart failure classified as New York Heart Association class 2, 3, or 4
- Any condition preventing study compliance or completion
- History of allergy to compounds similar to betaine
- Current use of betaine or S-adenosylmethionine supplements or refusal to stop using them during the study
- Known cystathionine beta-synthase deficiency
- Pregnancy, breastfeeding, or refusal to use birth control measures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
Actively Recruiting
Research Team
T
Timothy R Morgan, MD
CONTACT
A
Aliya Asghar, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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