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

NCT06166797 | Unknown

• 1 other identifier: 2021p-003599
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• peak growth hormone

  peak growth hormone level during standard 3-hour glucagon stimulation test

  at baseline

Study Arms (3)

No NAFLD

individuals with \<5 percent hepatic fat fraction on magnetic resonance spectroscopy

Simple Steatosis

individuals with at least 10% fat fraction on magnetic resonance spectroscopy without any history of nonalcoholic steatohepatitis or evidence of fibrosis

Nonalcoholic Steatohepatitis

individuals with biopsy confirmed nonalcoholic steatohepatitis and stage 2 or 3 fibrosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men 18-70yo with or without nonalcoholic fatty liver disease

You may qualify if:

• Men 18-70yo
• BMI between 25kg/m2 - 40kg/m2.
• Hepatitis C antibody and Hepatitis B surface antigen negative.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Steven Grinspoon, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Takara Stanley, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Takara L Stanley, MD

CONTACT

617-724-9109; tstanley@mgh.harvard.edu

Allison Arpante, NP

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 12, 2023
• Study Start: December 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12