Nonalcoholic Fatty Liver Disease
Conditions
Brief summary
The purpose of this study is to investigate relationships between the body's growth hormone axis and nonalcoholic fatty liver disease. The growth hormone axis includes the hormones growth hormone and insulin-like growth factor 1, and associated proteins. We hypothesize that there will be a relationship such that people with more advanced nonalcoholic fatty liver disease will have greater impairments in the growth hormone axis. There are no treatments associated with this research study.
Detailed description
Several lines of existing research implicate activity of the GH/IGF-1 axis in the development of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) in humans. Careful phenotyping of GH dynamics in individuals with NAFLD and NASH is required for comprehensive understanding of the degree to which perturbations in the GH axis contribute to the pathogenesis of NAFLD/NASH. The purpose of this research is to comprehensively assess GH dynamics in individuals across the spectrum of NAFLD to determine associations between the GH/IGF-1 axis and stages of disease progression in NAFLD.
Interventions
None listed
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| peak growth hormone | at baseline | peak growth hormone level during standard 3-hour glucagon stimulation test |
Contacts
Primary ContactTakara L Stanley, MD
Backup ContactAllison Arpante, NP
Outcome results
None listed