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

Phase 2

Completed

• Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)
• Interventions: Drug: Placebo; Drug: Growth hormone

• Registration Number: NCT02217345
• Lead Sponsor: Massachusetts General Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-08-13
• Study First Posted: 2014-08-15
• Study Start: 2017-06-02
• Primary Completion: 2021-08-10
• Study Completion: 2021-09-13
• Results First Submitted: 2022-09-13
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-28
• Last Update Submitted: 2022-10-28
• Results First Posted: 2022-11-22
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo will be administered by daily injection in this double blind study design. Sham dosing will be performed to maintain blinding.
Growth hormone	Growth hormone	Growth hormone (somatropin) administered by daily injection at starting dose of 0.3 mg daily for women and 0.2 mg daily for men, with dose titration for goal IGF-1 in the upper quartile of normal for age.

Primary Outcome Measures

Name	Time	Method
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.	6 months	Change in Intrahepatic lipid content by 1H-MRS over 6 months in the GH vs placebo group

Secondary Outcome Measures

Name	Time	Method
Change in Serum High Sensitivity C-reactive Protein (hsCRP) Between Baseline and 6 Months.	6 months	Change in serum high sensitivity C-reactive protein (hsCRP) (mg/L) between baseline and 6 months.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States