Trial Summary
What is the purpose of this trial?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.
Is the drug Betaine a promising treatment for heart failure?The information provided focuses on a different drug called Trimetazidine, not Betaine. Therefore, there is no evidence from these articles to suggest that Betaine is a promising treatment for heart failure.23679
What safety data exists for Betaine in heart failure treatment?The provided research does not contain safety data for Betaine (trimethylglycine) in heart failure treatment. The studies focus on trimetazidine, a different compound, and its effects on heart failure and angina.23789
What data supports the idea that Betaine for Heart Failure is an effective treatment?The available research shows that there is no specific data on Betaine for Heart Failure in the provided information. Instead, the studies focus on another drug called Trimetazidine (TMZ) and its effects on heart failure. These studies suggest that Trimetazidine may help improve symptoms and heart function in patients with heart failure, but they do not provide any information about Betaine's effectiveness for this condition.13459
Do I need to stop my current medications to join the trial?The protocol does not specify if you need to stop your current medications, but you cannot use betaine or S-adenosylmethionine supplements during the study.
Eligibility Criteria
This trial is for adults aged 18-75 with non-alcoholic fatty liver disease, elevated ALT levels (a liver enzyme), and normal platelet counts. They must not have severe liver or kidney issues. Group 1 specifically includes diabetic patients with high fasting blood sugar or HgA1c levels.Inclusion Criteria
I am between 18 and 75 years old.
I have been diagnosed with non-alcoholic fatty liver disease.
Treatment Details
The study tests two different doses of Betaine, a dietary supplement taken orally as a powder mixed in liquid. It aims to see if Betaine can improve liver health in people with fatty liver disease and type 2 diabetes.
2Treatment groups
Active Control
Group I: diabetic patients with NAFLDActive Control1 Intervention
Patients will be prescribed 4 grams of betaine/day (2 grams PO BID) for the first 4 weeks of the study. After 4 weeks, patients in each cohort will be randomized (1:1) to continue receiving betaine 4 grams per day or increase to 8 grams per day for an additional 8 weeks.
Group II: non-diabetics with NAFLDActive Control1 Intervention
Patients will be prescribed 4 grams of betaine/day (2 grams PO BID) for the first 4 weeks of the study. After 4 weeks, patients in each cohort will be randomized (1:1) to continue receiving betaine 4 grams per day or increase to 8 grams per day for an additional 8 weeks.
Betaine (trimethyglycine) is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Betaine for:
- Homocystinuria
🇺🇸 Approved in United States as Cystadane for:
- Homocystinuria
Find a clinic near you
Research locations nearbySelect from list below to view details:
VA Long Beach Healthcare SystemLong Beach, CA
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Who is running the clinical trial?
Southern California Institute for Research and EducationLead Sponsor
References
[Trimetazidine effects on exercise tolerance and left ventricular diastolic function in patients with coronary heart disease]. [2016]Trial of trimetasidine effects on exercise tolerance (ET) and left ventricular diastolic function (LVDF) in patients with coronary heart disease (CHD).
[Comparative trial of efficacy of trimethasidine MB and 3-(2,2,2-trimethylhydrasine) propionate dihydrate in chronic heart failure]. [2016]To study efficacy of the myocardial cytoprotector trimethasidine MB and metabolic drug 3-(2,2,2-trimethylhydrasine) propionate dihydrate (3-TMHP) in the treatment of chronic cardiac failure (CCF).
Trimetazidine: a meta-analysis of randomised controlled trials in heart failure. [2013]To explore whether trimetazidine could improve symptoms, cardiac functions and clinical outcomes in patients with heart failure (HF).
Additional use of trimetazidine in patients with chronic heart failure: a meta-analysis. [2022]The aim of this meta-analysis was to evaluate the effects of additional trimetazidine (TMZ) treatment on patients with chronic heart failure (CHF).
Effect of partial fatty acid oxidation inhibition with trimetazidine on mortality and morbidity in heart failure: results from an international multicentre retrospective cohort study. [2018]The aim of this cohort study was to retrospectively evaluate, in patients with chronic heart failure (CHF), the long term effect of trimetazidine (TMZ) on morbidity and mortality.
Effects of trimetazidine in nonischemic heart failure: a randomized study. [2016]Heart failure (HF) is associated with changes in myocardial metabolism that lead to impairment of contractile function. Trimetazidine (TMZ) modulates cardiac energetic efficiency and improves outcomes in ischemic heart disease. We evaluated the effects of TMZ on left ventricular ejection fraction (LVEF), cardiac metabolism, exercise capacity, O2 uptake, and quality of life in patients with nonischemic HF.
The effect of trimetazidine added to pharmacological treatment on all-cause mortality in patients with systolic heart failure. [2015]The anti-ischemic agent trimetazidine (TMZ) added to pharmacological treatment appears to have positive effects on cardiac parameters of patients with heart failure (HF) as a result of specific antioxidant properties.
Anti-Anginal Effectiveness and Tolerability of Trimetazidine Modified Release 80 Mg Once Daily in Stable Angina Patients in Real-World Practice. [2022]Trimetazidine (TMZ) was shown to reduce angina symptoms and increase the exercise capacity in stable angina (SA) patients. A new formulation allowing a once-daily (od) dosage could improve patients' satisfaction and adherence.
Effects of trimetazidine in patients with severe chronic heart failure with reduced left ventricular ejection fraction: A prospective, randomized, open-label, cross-over study. [2022]Trimetazidine (TMZ) modulates cardiac metabolism, but its use in heart failure remains controversial. The aim of the study was to evaluate the effects of TMZ on exercise capacity, left ventricular ejection fraction (LVEF), mortality, and quality of life in stable patients with heart failure with reduced left ventricular ejection fraction (HFrEF).