Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/31/2019 |
| Start Date: | September 2015 |
| End Date: | January 2021 |
| Contact: | Laura Dichtel |
| Email: | ldichtel@partners.org |
| Phone: | 617-724-3614 |
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).
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).
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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Karen K Miller, MD
Phone: 617-726-3870
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