Phase 2
N=53
Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Nonalcoholic Fatty Liver Disease (NAFLD)
Bottom Line
View on ClinicalTrials.gov: NCT02217345 ↗Enrolled (actual)
53
Serious AEs
2.0%
Results posted
Nov 2022
Primary outcome: 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. — -5.2; 3.8 percent liver fat
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Growth hormone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
-5.2; 3.8 | — |
| SECONDARY Change in Serum High Sensitivity C-reactive Protein (hsCRP) Between Baseline and 6 Months. |
-0.8; 0.3 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Ages 18 - 65 yr
- 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
- Serum creatinine > 2 times the upper limit of normal
- History of cancer, except for non-melanoma skin cancers
- Active carpel tunnel syndrome
- 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 = 10x upper limit of normal
Data sourced from ClinicalTrials.gov (NCT02217345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.