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Betaine for Non-Alcoholic Fatty Liver Disease and Diabetes

This study is looking at how two different doses of betaine (trimethyglycine), a common food supplement, affect people with non-alcoholic fatty liver disease (NAFLD) and high liver enzyme levels (ALT). Some participants also have type 2 diabetes. Researchers want to see if betaine can lower ALT levels after 12 weeks. You may be able to join if you are 18-75 years old, have NAFLD, and your ALT levels are 60 IU/mL or higher. The study aims to enroll 48 participants in total.

Study design
This is an open-label, randomized study involving 48 participants. Participants will be divided into two groups: those with diabetes and those without. After an initial period, participants will be randomly assigned to receive either 4 grams or 8 grams of betaine daily.
What's involved
You will take betaine powder mixed with liquid daily for 12 weeks. You will also receive dietary and exercise advice. You will have monthly clinic visits during treatment, and then follow-up visits 4 and 12 weeks after you stop taking betaine.
Compensation
Not stated in the trial record.
Follow-up
You will have follow-up visits 4 and 12 weeks after you complete betaine treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03073343

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

UNKNOWN
NAAges 18–75InterventionalTreatment
Southern California Institute for Research and Education
~48 participants
Updated 2024-05-07 on ClinicalTrials.gov
What's tested:Betaine (trimethyglycine)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in alanine aminotransferase (ALT) level in all study participants
Measured over after 12 weeks of Betaine

Conditions

Non-Alcoholic Fatty Liver Disease
Non Insulin Dependent Diabetes
ALT

Explore related trials

Diabetes MellitusInsulin ResistanceNonalcoholic Fatty Liver Disease

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Timothy R Morgan, MD · PRINCIPAL_INVESTIGATOR · VA Long Beach Healthcare System

Who to contact

Timothy R Morgan, MD
[email protected]
562-826-5212
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Platelets \> 100,000/dL
Total bilirubin \< 2 mg/dL
Creatinine \< 1.6 mg/dL
Fasting blood sugar ≥ 126mg/dL
Hemoglobin A1c (HgA1c) of \> 6.5%
2-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

What this trial measures

  • Change in alanine aminotransferase (ALT) level in all study participantsafter 12 weeks of Betaine

    Compare the week 12 ALT levels with the baseline ALT in study patients. Comparison will be performed using a paired t-test.