Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis
Lead Sponsor:
Indiana University
Conditions:
NASH - Nonalcoholic Steatohepatitis
Cirrhosis, Liver
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an open-label, randomized study comparing a monitored ketogenic diet intervention using standard ketogenic diet (SKD) and standard of care (SOC) dietary recommendations for 16 weeks. Subjects ...
Detailed Description
The primary aim is to assess the safety of ketogenic diet as compared to standard of care approach for weight loss in patients with compensated cirrhosis due to NASH. The safety endpoints captured in ...
Eligibility Criteria
Inclusion
- NASH cirrhosis (criteria in Appendix 1) with obesity (BMI \>30 kg/m2).
- Age 18 and greater
Exclusion
- Actively participation in investigational drug treatment for non-alcoholic fatty liver disease
- Currently taking medications for weight loss or have joined a supervised weight loss program prior to enrollment
- Have hepatocellular carcinoma and are undergoing therapy
- Women who become pregnant or plan to become pregnant prior to the study date; female subjects who become pregnant during the study will be withdrawn from the study
- Pacemaker or implantable cardioverter devices
- History of hepatic surgery
- Current significant alcohol consumption, defined as more than 20 grams per day in females or 30 grams per day in males
- Presence of ascites or hepatic encephalopathy
- Symptomatic gastroparesis
- Uncontrolled diabetes, as defined by a HgbA1C \>11%
- Uncontrolled congestive heart failure
- Active infections
- Child Turcotte Pugh score \> 6
- MELD score \>12
- Unwilling to undergo an MRI or have contraindications to an MRI
Key Trial Info
Start Date :
August 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04383951
Start Date
August 15 2020
End Date
December 31 2026
Last Update
March 10 2025
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202