Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease

Nonalcoholic Fatty Liver Disease (NAFLD) Clinical Trial

— NAFLD  

Official title:

Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217345
• Other study ID #: 2014P001680
• Status: Completed
• Phase: Phase 2
• Start date: June 2, 2017
• Est. completion date: September 13, 2021

Study information

• Verified date: October 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates of about 30% of individuals in the United States. A subset of these will develop progressive disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis and liver failure. NAFLD is expected to be the most common indication for liver transplantation by the year 2020. We hypothesize that growth hormone (GH) replacement will decrease intrahepatic lipid accumulation as quantified by 1H magnetic resonance spectroscopy (1H-MRS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: September 13, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Ages 18 - 65 yr

2. NAFLD defined as demonstration of hepatic steatosis by imaging or biopsy in absence of significant alcohol consumption and other causes of hepatic steatosis. If liver imaging or biopsy has not been performed clinically, liver ultrasound will be performed as part of the screening visit.

Exclusion Criteria:

1. Serum creatinine > 2 times the upper limit of normal

2. History of cancer, except for non-melanoma skin cancers

3. Active carpel tunnel syndrome

4. Diabetes mellitus, defined as a hemoglobin A1C >6.5 or use of any medications prescribed to treat hyperglycemia. The exception is that the use of metformin is acceptable in patients whose HbA1c has been =<6.0 on two visits and whose weight has remained stable for six months.

5. Contraindications to magnetic resonance imaging (MRI).

6. Pregnancy or desire to become pregnant. Participants of reproductive age must agree to use contraception.

7. Breastfeeding

8. Aspartate and aminotransferase levels >10x upper limit of normal

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease (NAFLD)

Intervention

Drug:
• Growth hormone
growth hormone, Genotropin (Pfizer)
• Placebo
placebo with identical drug pen delivery device and packaging as Genotropin (Pfizer)

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intrahepatic Lipid Content Between Baseline and 6 Months as Measured by 1H-magnetic Resonance Spectroscopy (1H-MRS). Endpoints Were Assessed at Baseline and 6 Months.	Change in Intrahepatic lipid content by 1H-MRS over 6 months in the GH vs placebo group	6 months
Secondary	Change in Serum High Sensitivity C-reactive Protein (hsCRP) Between Baseline and 6 Months.	Change in serum high sensitivity C-reactive protein (hsCRP) (mg/L) between baseline and 6 months.	6 months