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New treatment option for Fatty Liver
Official title Intermittent Fasting for NAFLD in Adults
ClinicalTrials.gov ID: NCT04899102
What this study is testing
- What it's testing
- NAFLD is a growing threat to public health. Currently, there is a significant need for highly effective treatments for NAFLD.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 months prior to the screening visit, defined as:
- Grade \>=1 steatosis on clinical liver biopsy; OR
You likely can't join if
- Heavy alcohol use for at least 3 consecutive months within the past 5 years prior to screening [heavy alcohol consumption is defined as: \> 20g daily...
- 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...
- Current or prior history of Type II Diabetes requiring insulin or sulfonylureas due to risk of hypoglycemia with fasting.
- Use of any pharmacological treatments for NAFLD/NASH within the 6 months prior to the screening visit, except vitamin E. Patients on a stable dose of...
- Unstable body weight [defined as: \>10% reduction in body weight in the 6 months prior to the screening visit]
See the full eligibility 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 months prior 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
- Heavy alcohol use for at least 3 consecutive months within the past 5 years prior to screening [heavy alcohol consumption is defined as: \> 20g daily for women or \> 30mg daily for men, assessed by the Lifetime Drinking...
- 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 liver injury, known or suspected hepatocellular carcinoma...
- Current or prior history of Type II Diabetes requiring insulin or sulfonylureas due to risk of hypoglycemia with fasting.
- Use of any pharmacological treatments for NAFLD/NASH within the 6 months prior to the screening visit, except vitamin E. Patients on a stable dose of vitamin E can be enrolled in the study.
- Unstable body weight [defined as: \>10% reduction in body weight in the 6 months prior to the screening visit]
- Known cirrhosis, stage 4 fibrosis on prior liver biopsy, or clinical evidence of cirrhosis 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 for weight loss, or active involvement in a weight loss program.
- Routine MRI exclusion criteria, such as the presence of a pacemaker or cerebral aneurysm clip.
- Chronic Kidney Disease (CKD) with eGFR \< 60.
- For women of child-bearing potential (WOCBP): positive urine hCG, trying to achieve pregnancy, or breastfeeding [a negative urine pregnancy test is required at screening for women of child-bearing potential].
- Other medical conditions or severe chronic illnesses that, in the opinion of the Investigator, may present a contraindication to study participation.
- Any other condition that, in the opinion of the Investigator, may hinder study compliance or completion of the study schedule of assessments.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.