Last updated: March 11, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Primary Biliary Cholangitis
Liver Disease
Treatment
Time-Restricted, Intermittent Fasting
Clinical Study ID
NCT04899102
2020P002672
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Willing and able to provide informed consent
- Age 18 years or older at time of consent
- BMI 23-30kg/m^2 at screening
- Evidence of NAFLD confirmed by historical procedure obtained no more than 6 monthsprior to the screening visit, defined as:
- Grade >=1 steatosis on clinical liver biopsy; OR
- Fatty liver on validated imaging modality (non-contrast CT scan, MR Spectroscopy,MRI proton density fat fraction, ultrasound)
- Liver fat fraction ≥10% on H-MRS performed during the screening period
- Hepatitis C antibody and Hepatitis B surface antigen negative at screening
Exclusion
Exclusion Criteria:
- Heavy alcohol use for at least 3 consecutive months within the past 5 years prior toscreening [heavy alcohol consumption is defined as: > 20g daily for women or > 30mgdaily for men, assessed by the Lifetime Drinking History assessment at screening (23, 24)].
- Evidence of other known forms of chronic liver disease including: • Alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis,Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liverinjury, known or suspected hepatocellular carcinoma (HCC).
- Current or prior history of Type II Diabetes requiring insulin or sulfonylureas due torisk of hypoglycemia with fasting.
- Use of any pharmacological treatments for NAFLD/NASH within the 6 months prior to thescreening visit, except vitamin E. Patients on a stable dose of vitamin E can beenrolled in the study.
- Unstable body weight [defined as: >10% reduction in body weight in the 6 months priorto the screening visit]
- Known cirrhosis, stage 4 fibrosis on prior liver biopsy, or clinical evidence ofcirrhosis or portal hypertension on imaging or exam.
- Current or prior history of Child-Pugh score ≥7.
- History of liver transplant, or current placement on a liver transplant list.
- Known positivity for human immunodeficiency virus infection.
- Prior or planned bariatric surgery, patients on active pharmacological treatment forweight loss, or active involvement in a weight loss program.
- Routine MRI exclusion criteria, such as the presence of a pacemaker or cerebralaneurysm clip.
- Chronic Kidney Disease (CKD) with eGFR < 60.
- For women of child-bearing potential (WOCBP): positive urine hCG, trying to achievepregnancy, or breastfeeding [a negative urine pregnancy test is required at screeningfor women of child-bearing potential].
- Other medical conditions or severe chronic illnesses that, in the opinion of theInvestigator, may present a contraindication to study participation.
- Any other condition that, in the opinion of the Investigator, may hinder studycompliance or completion of the study schedule of assessments.
Study Design
Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Time-Restricted, Intermittent Fasting
Phase:
Study Start date:
February 01, 2022
Estimated Completion Date:
July 31, 2025
Study Description
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting

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