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

Status unconfirmed · Not applicable

Conditions studied: Non-Alcoholic Fatty Liver Disease, Non Insulin Dependent Diabetes, ALT

In brief

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.

Key facts

Study ID

NCT03073343

Run by

Southern California Institute for Research and Education

People needed

48

Starts

2013-11-12

Expected to finish

2025-12-30

Last updated by the study team

2024-05-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria for all patients:
• 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
• Inclusion Criteria for Group 1: diabetic patients
• 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

You may not qualify if…

• 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

Where it is running

• VA Long Beach Healthcare System — Long Beach, California, United States (enrolling)

Full record on ClinicalTrials.gov

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