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Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT02217345•Massachusetts General Hospital

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

June 2, 2017

Primary Completion Date

August 10, 2021

Completion Date

September 13, 2021

Last Updated

November 22, 2022

Enrollment

131

ACTUAL participants

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD)

Interventions

Growth hormone

DRUG

Placebo

DRUG

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COMPLETEDPHASE2/PHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally in Subjects With Nonalcoholic Fatty Liver Disease

Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children

Tesamorelin Effects on Liver Fat and Histology in HIV

Screening With FibroTouch for Advanced Liver Fibrosis in NAFLD Patients With Underlying Type 2 Diabetes

Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease