RECRUITING

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

Conditions

Non-Alcoholic Fatty Liver Disease Non Insulin Dependent Diabetes ALT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2013-11-12

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03073343

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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	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

Inclusion Criteria

Exclusion Criteria

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

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

Contacts and Locations

Study Contact

Timothy R Morgan, MD

CONTACT

562-826-5212

timothy.morgan@va.gov

Aliya Asghar, MPH

CONTACT

562-826-5212

aliya.asghar@va.gov

Principal Investigator

Timothy R Morgan, MD

PRINCIPAL_INVESTIGATOR

VA Long Beach Healthcare System

Study Locations (Sites)

VA Long Beach Healthcare System

Long Beach, California, 90822

United States

Collaborators and Investigators

Sponsor: Southern California Institute for Research and Education

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-11-12

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2013-11-12

Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

Non-Alcoholic Fatty Liver Disease
Non Insulin Dependent Diabetes
ALT