Status:
COMPLETED
Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Nonalcoholic Fatty Liver Disease (NAFLD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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% o...
Eligibility Criteria
Inclusion
- 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
- 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 =\<6.0 on two visits and whose weight has remained stable for six months.
- Contraindications to magnetic resonance imaging (MRI).
- Pregnancy or desire to become pregnant. Participants of reproductive age must agree to use contraception.
- Breastfeeding
- Aspartate and aminotransferase levels \>10x upper limit of normal
Key Trial Info
Start Date :
June 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2021
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT02217345
Start Date
June 2 2017
End Date
September 13 2021
Last Update
November 22 2022
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114