RECRUITING

Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans

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

Nonalcoholic steatohepatitis (NASH) is the aggressive form of nonalcoholic fatty liver disease, which is rapidly becoming a worldwide public health problem. It is more common in the military and Veteran population compared to the general US population. NASH may progress to end-stage liver disease and primary liver cancer, and hence there is critical need for effective treatment. The goal of this clinical trial is to test whether low dose thyroid hormone administered to Veterans diagnosed with NASH can be an effective therapy mediated by improvement in breaking down fat in the mitochondria. The study will be conducted in two stages, the first stage is for proof of concept to be followed by interim analysis. If the interim analysis supports the merit for continuing the study, the clinical trial will proceed to stage 2 for continuation. This study will provide new information and strategies for treatment of NASH using low dose thyroid hormone that will be highly relevant and impactful to the health of the Veteran population.

Official Title

Low Dose Thyroid Hormone, Mitochondrial Fatty Acid Oxidation, and Treatment of Nonalcoholic Steatohepatitis (NASH)

Quick Facts

Study Start:2023-04-01
Study Completion:2029-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05526144

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 CriteriaExclusion Criteria
  1. * Men and women (pre- and post-menopausal)
  2. * Overweight/obese subjects with body mass index (BMI) at or above 25.9 kg/m2
  3. * Alcohol intake \< 20 grams per day
  4. * Patients with type 2 diabetes on stable doses of antidiabetic medication for at least 3 months before enrollment
  5. * Patients who are treated with vitamin E or pioglitazone should be on stable doses for at least 6 months before enrollment
  6. * Features of metabolic syndrome: 3 or more (central obesity, hypertension, low HDL, high triglycerides, high fasting glucose)
  7. * Scheduled for a medically indicated, diagnostic liver biopsy
  8. * Female patients are eligible if they are of reproductive potential and have a negative serum pregnancy test (beta human chorionic gonadotropin), are not breastfeeding, and do not plan to become pregnant during the study and agree to use two highly effective birth control methods during the study OR if they are not of child-bearing potential (i.e., surgically \[bilateral oophorectomy, hysterectomy, or tubal ligation\] or naturally sterile \[\> 12 consecutive months without menses\])
  9. * Highly effective birth control methods include condoms with spermicide, diaphragm with spermicide, hormonal and nonhormonal intrauterine device, hormonal contraception (estrogens stable for at least 3 months), a vasectomized male partner, or sexual abstinence (defined as refraining from heterosexual intercourse), from screening, throughout the study, and for at least 30 days after the last dose of study drug administration
  10. * Reliance on abstinence from heterosexual intercourse is acceptable only if it is the patient's habitual practice
  11. * If a patient is on digitalis and amiodarone, he/she is expected to use/continue these medications throughout the treatment period only after consultation with their cardiologist for monitoring and dose adjustments if necessary
  1. * Other causes of hepatitis including hepatitis B \& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, medication-induced hepatitis
  2. * Alcohol consumption of 20 g/d or more
  3. * Patients with cirrhosis, bilirubin of 1.3 mg/dL or more, and INR of 1.3 or more
  4. * Evidence of Portal hypertension
  5. * Pregnancy
  6. * History of malignant hypertension
  7. * Uncontrolled hypertension (either treated or untreated) defined as systolic blood pressure \> 160 mm Hg or a diastolic blood pressure \> 100 mm Hg at screening
  8. * New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \< 30%
  9. * Uncontrolled cardiac arrhythmia, including confirmed QT interval corrected using Fridericia's formula (QTcF) \> 450 msec for males and \> 470 msec for females at the screening electrocardiogram (ECG) assessment
  10. * History of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within at least 3 months prior to randomization
  11. * History of high degree AV block (Mobitz II or complete) in the absence of a pacemaker
  12. * Patients with uncorrected adrenal insufficiency
  13. * Patients who are on tricyclic or tetracyclic antidepressants or ketamine, if they are unwilling and/or unable to discontinue these medications to allow adequate washout prior to randomization
  14. * Patients who are on Teduglutide or Midodrine

Contacts and Locations

Study Contact

Adam T Whaley-Connell, DO MSPH
CONTACT
(573) 814-6552
Adam.Whaley-Connell@va.gov
Jennifer A Atherton
CONTACT
(573) 814-6000
Jennifer.Atherton@va.gov

Principal Investigator

Jamal A Ibdah, MD PhD
PRINCIPAL_INVESTIGATOR
Harry S. Truman Memorial, Columbia, MO

Study Locations (Sites)

Harry S. Truman Memorial, Columbia, MO
Columbia, Missouri, 65201-5275
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jamal A Ibdah, MD PhD, PRINCIPAL_INVESTIGATOR, Harry S. Truman Memorial, Columbia, MO

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 Date2023-04-01
Study Completion Date2029-03-31

Study Record Updates

Study Start Date2023-04-01
Study Completion Date2029-03-31

Terms related to this study

Keywords Provided by Researchers

  • Thyroid hormone
  • Nonalcoholic fatty liver disease (NAFLD)
  • Nonalcoholic steatohepatitis (NASH)
  • Mitochondrial fatty acid oxidation

Additional Relevant MeSH Terms

  • Nonalcoholic Steatohepatitis
  • Liver Fibrosis