Non-Alcoholic Fatty Liver Disease, the Hepatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Summary
Background: In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help. Objective: To find out how the liver in people with NAFLD responds to feeding, and how this relates to their response to the drug semaglutide. Eligibility: People with NAFLD and healthy volunteers ages 18 and older Design: Participants will be screened with: Medical history Physical exam Blood tests Imaging: A machine will take pictures of the participant s body. Within 2-8 weeks of enrollment, participants will stay in the clinic for several days. This includes: Blood, urine, heart, and imaging tests For NAFLD participants only: A needle-like device will remove a small biopsy of the liver and fatty tissue. Participants will be alone in a special room for 5 hours. They will breathe through a tube under the nostrils. They will have blood drawn several times. The baseline visit concludes participation for healthy volunteers but NAFLD participants will contine. About 6 weeks after discharge, participants will stay in the clinic again and repeat the tests. They will get their first semaglutide dose by injection. Participants will have visits weeks 1, 2, 4, 8, 12, 16, 20, and 24 of treatment. Visits include blood tests. Participants will inject semaglutide once a week at home. At week 30, participants will stay in the clinic again and repeat the tests. Participants will have a final visit 12 weeks after stopping treatment. This includes blood and urine tests. ...
Description
Non-alcoholic fatty liver disease (NAFLD) and its progressive form, non-alcoholic steatohepatitis (NASH), are leading causes of liver injury and are tightly associated with obesity, diabetes and the metabolic syndrome. Despite recent advances, there is still a considerable knowledge gap regarding the fundamental pathogenic mechanisms, and especially regarding the transition from benign steatosis to steatohepatitis. Although NAFLD reflects disordered energy metabolism in the liver, little information exists on the response of the human liver to the acute caloric load of a meal. We hypothesize,…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- Yes
* INCLUSION CRITERIA: 1. Male or female Aged \>= 18 years of age. 2. Histological evidence of hepatic steatosis on a liver biopsy within 12 months OR evidence of fatty liver disease, as documented by imaging (ultrasound, CT, MRI, MRI-PDFF, MR spectroscopy, or Fibroscan CAP \>= 285 db/M25) within 12 months. 3. Estimated average alcohol consumption \< 30 g/d for men or \< 20 g/d for women in the 6 months prior to enrollment and no binge-drinking behavior. 4. Ability of subject to understand and the willingness to sign a written informed consent document. Additional Inclusion Criteria f…
Interventions
- DrugSemaglutide
Semaglutide injection once weekly
Location
- National Institutes of Health Clinical CenterBethesda, Maryland