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Trial record 50 of 107 for:    alanine | Non-Alcoholic Steatohepatitis

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

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ClinicalTrials.gov Identifier: NCT03073343
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy Morgan, MD, Southern California Institute for Research and Education

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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Non Insulin Dependent Diabetes ALT Dietary Supplement: Betaine (trimethyglycine) Not Applicable

Detailed Description:

This is a prospective, unblinded, randomized study of oral betaine in diabetic and non-diabetic patients who have a clinical diagnosis of NAFLD and an ALT≥ 50 IU/mL. A clinical diagnosis of NAFLD is based on the presence of risk factors for NAFLD (such as overweight and insulin resistance) and the exclusion of other causes of liver disease, such as alcohol or viral hepatitis.

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.

Patients will be given dietary instructions and advice on exercise appropriate for the management of NAFLD (NIDDK and liverfoundation.org handouts). 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 (NIDDM and non-diabetic) 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. All patients will be seen in clinic on a monthly basis during treatment, and again 4 and 12 weeks after completion of betaine treatment. The total duration of the study is 24 weeks (12 weeks of betaine treatment and 12 weeks of follow-up).

The primary outcome is change in ALT during 12 weeks of betaine treatment (i.e., ALT at week 12 compared with ALT at baseline (entry). Secondary outcomes include safety, efficacy of betaine in each cohort, and are changes in laboratory tests related to NAFLD.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 12, 2013
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020


Arm Intervention/treatment
Active Comparator: diabetic patients with NAFLD
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)
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.

Active Comparator: non-diabetics with NAFLD
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)
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.




Primary Outcome Measures :
  1. Change in alanine aminotransferase (ALT) level in all study participants [ Time Frame: after 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.


Secondary Outcome Measures :
  1. Compare changes in alanine aminotransferase (ALT) level in both cohorts [ Time Frame: after 12 weeks of Betaine ]
    A Paired T test analysis will compare changes in ALT levels between Patients with NIDDM (cohort 1) and Patients without NIDDM (cohort 2)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria for all patients:

  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

Exclusion Criteria:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073343


Contacts
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Contact: Timothy R Morgan, MD 562-826-5212 timothy.morgan@va.gov
Contact: Aliya Asghar, MPH 562-826-5212 aliya.asghar@va.gov

Locations
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United States, California
VA Long Beach Healthcare System Recruiting
Long Beach, California, United States, 90822
Contact: Aliya Asghar, MPH    562-826-5212    aliya.asghar@va.gov   
Contact: Timothy R Morgan, MD    562-826-5212    timothy.morgan@va.gov   
Sponsors and Collaborators
Southern California Institute for Research and Education
Investigators
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Principal Investigator: Timothy R Morgan, MD VA Long Beach Healthcare System

Publications:
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Responsible Party: Timothy Morgan, MD, Chief, Hepatology, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT03073343     History of Changes
Other Study ID Numbers: Betaine 2
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with anyone outside authorized research personnel.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Diabetes Mellitus, Type 2
Digestive System Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Betaine
Gastrointestinal Agents
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents