Oral betaine treatment for non-alcoholic fatty liver disease
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)
This study is testing if taking a food supplement called betaine can help people with non-alcoholic fatty liver disease and high liver enzyme levels feel better over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Southern California Institute for Research and Education Academic / other |
| Locations | 1 site (Long Beach, California) |
| Trial ID | NCT03073343 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of oral betaine, a food supplement, on patients diagnosed with non-alcoholic fatty liver disease (NAFLD) and elevated alanine aminotransferase (ALT) levels. The study includes two cohorts: diabetic patients and non-diabetic patients with insulin resistance. Participants will receive either 4 grams or 8 grams of betaine daily over a 12-week treatment period, followed by a 12-week follow-up. Monthly clinic visits will monitor patient progress and adherence to dietary and exercise recommendations.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with a clinical diagnosis of NAFLD and elevated ALT levels, either with or without type 2 diabetes.
Not a fit: Patients with liver diseases other than NAFLD or those with contraindications to betaine will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve liver health and metabolic parameters in patients with NAFLD.
How similar studies have performed: While the use of betaine for liver conditions has been explored, this specific approach in the context of NAFLD and diabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
Exclusion Criteria:
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
Where this trial is running
Long Beach, California
- VA Long Beach Healthcare System — Long Beach, California, United States (Recruiting)
Study contacts
- Principal investigator: Timothy R Morgan, MD — VA Long Beach Healthcare System
- Study coordinator: Timothy R Morgan, MD
- Email: timothy.morgan@va.gov
- Phone: 562-826-5212
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.