Elucidating Growth Hormone Dynamics at Stages of Progressive Nonalcoholic Fatty Liver Disease

Launched by MASSACHUSETTS GENERAL HOSPITAL · Dec 11, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to understand how growth hormones in the body relate to nonalcoholic fatty liver disease (NAFLD). Researchers believe that as NAFLD becomes more advanced, the way growth hormones function may become more impaired. The study aims to explore this connection and does not involve any treatments for participants.

To be eligible for this trial, men between the ages of 18 and 70 who have a body mass index (BMI) between 25 and 40 may qualify. Participants must not have certain liver conditions, must not consume heavy alcohol, and should not be using specific medications for liver disease. They will be grouped based on their medical history and liver health, which will be checked through tests. Those who join the study can expect to undergo some evaluations related to their liver health, but there will be no treatment provided as part of the research. It’s important to note that the study is not yet recruiting participants.

Gender

MALE

Eligibility criteria

• Inclusion criteria:
• • Men 18-70yo
• • BMI between 25kg/m2 - 40kg/m2.
• • Hepatitis C antibody and Hepatitis B surface antigen negative.
• • Meet inclusion criteria for one of Groups 1-3 based on medical history, laboratory criteria, and hepatic fat fraction (1H-MRS) and/or liver biopsy
• • Group 1: No NAFLD: no history of NAFLD/NASH, hepatic fat fraction \<5% on 1H-MRS, ALT \< 30 U/L.
• • Group 2: Simple Steatosis: no history of NASH, hepatic fat fraction ≥10% on 1H-MRS, ALT \< 30 U/L.
• • Group 3: Nonalcoholic Steatohepatitis: Biopsy confirmed NASH within the year prior to study participation, with liver fibrosis stage 2 or 3 on biopsy.
• Exclusion criteria:
• • Heavy alcohol use defined as consumption of \> 30mg daily for at least 3 consecutive months over the past 5 years
• • Type 1 diabetes, any use of insulin, or any use of other anti-diabetes medication except metformin or sulfonylurea. Individuals with Type 2 diabetes that is controlled by diet or by metformin and/or sulfonylurea will be eligible.
• • Use of any specific pharmacological treatments for NAFLD/NASH except vitamin E within the 3 months before screening visit.
• • Chronic systemic corticosteroid use in the ≤6 months prior to the baseline visit.
• • Chronic use of Actigall, methotrexate, amiodarone, or tamoxifen
• • Known diagnosis of alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, or autoimmune hepatitis
• • Use of GH or GHRH within the past 6 months
• • Change in lipid lowering or anti-hypertensive regimen within 2 months of screening
• • Hemoglobin \< 12.5 g/dL
• • Severe chronic illness judged by the investigator to present a contraindication to participation
• • History of hypopituitarism, head irradiation or any other condition known to affect the GH axis.
• • Use of testosterone or estrogen or progesterone unless physiologic stable testosterone use for at least 1 year prior to study entry
• • Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip
• • Weight loss surgery within 1 year before baseline. Weight loss surgery more than 1 year prior to baseline visit is permissible if no active weight loss (\<10% decrease in weight over past 6 months)
• • Lack of fluency in English and/or inability to complete the consent process in English.
• • Judge by the investigator to be inappropriate for the study for other reasons not detailed above.