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

NCT03073343 | Recruiting

• 1 other identifier: Betaine 2
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Non-Alcoholic Fatty Liver Disease; Non Insulin Dependent Diabetes; ALT

Outcome Measures

Primary Outcomes (1)

• Change in alanine aminotransferase (ALT) level in all study participants

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

  after 12 weeks of Betaine

Secondary Outcomes (1)

• Compare changes in alanine aminotransferase (ALT) level in both cohorts

  after 12 weeks of Betaine

Study Arms (2)

diabetic patients with NAFLD

ACTIVE COMPARATOR

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.

Dietary Supplement: Betaine (trimethyglycine)

non-diabetics with NAFLD

ACTIVE COMPARATOR

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.

Dietary Supplement: Betaine (trimethyglycine)

Interventions

Betaine (trimethyglycine) DIETARY_SUPPLEMENT

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.

diabetic patients with NAFLD; non-diabetics with NAFLD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. At least one of the following:
• Fasting blood sugar ≥ 126mg/dL
• Hemoglobin A1c (HgA1c) of \> 6.5%
• 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

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

Sponsors & Collaborators

• Southern California Institute for Research and Education: lead

Study Sites (1)

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

RECRUITING

Related Publications (2)

• Matteoni CA, Younossi ZM, Gramlich T, Boparai N, Liu YC, McCullough AJ. Nonalcoholic fatty liver disease: a spectrum of clinical and pathological severity. Gastroenterology. 1999 Jun;116(6):1413-9. doi: 10.1016/s0016-5085(99)70506-8.

  PMID: 10348825 BACKGROUND

• Caldwell SH, Oelsner DH, Iezzoni JC, Hespenheide EE, Battle EH, Driscoll CJ. Cryptogenic cirrhosis: clinical characterization and risk factors for underlying disease. Hepatology. 1999 Mar;29(3):664-9. doi: 10.1002/hep.510290347.

  PMID: 10051466 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

Interventions

Betaine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Timothy R Morgan, MD

  VA Long Beach Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy R Morgan, MD

CONTACT

562-826-5212; timothy.morgan@va.gov

Aliya Asghar, MPH

CONTACT

562-826-5212; aliya.asghar@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Hepatology

Model Details: Two cohorts of patients will be studied: Cohort 1 (diabetic) will consist of patients with a clinical diagnosis of non-insulin dependent type II diabetes mellitus; Cohort 2 (non-diabetics) will consist of patients without a clinical diagnosis of type 2 diabetes mellitus. 24 patients will be enrolled in each cohort (total of 48 patients enrolled in the study) with an anticipated drop out of 4 subjects per cohort.

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 8, 2017
• Study Start: November 12, 2013
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)