Clinical trial NCT04383951: Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis
Official title: Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: NASH - Nonalcoholic Steatohepatitis
Cirrhosis, Liver
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomization will be utilized to ensure balancing of treatment groups throughout enrollment. 30 participants will be assigned to the ketogenic diet arm and 10 will be assigned to standard of care.
Primary purpose: TREATMENT

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 enrolled in the standard of care group will receive a voucher to Weight Watchers after study completion.

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 the study include liver decompensation events, measured through several questionnaires, fasting blood glucose, serum creatinine, fasting lipid profile and other adverse events. The tolerability of the ketogenic diet will be assessed by study compliance and by administering a questionnaire.

Secondary aims include weight loss, changes in body composition via serial use of bioelectrical impedance via an Inbody Machine, changes in liver fat and liver stiffness using MRI and proton density fat fraction (MRI-PDFF), liver biochemistries, changes in Child-Turcotte-Pugh and MELD scores measured via labs and changes in liver steatosis and stiffness via serial measures of VCTE by FibroScan®.

Eligibility criteria: Inclusion Criteria:

1. NASH cirrhosis (criteria in Appendix 1) with obesity (BMI \>30 kg/m2).
2. Age 18 and greater

Exclusion Criteria:

1. Actively participation in investigational drug treatment for non-alcoholic fatty liver disease
2. Currently taking medications for weight loss or have joined a supervised weight loss program prior to enrollment
3. Have hepatocellular carcinoma and are undergoing therapy
4. 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
5. Pacemaker or implantable cardioverter devices
6. History of hepatic surgery
7. Current significant alcohol consumption, defined as more than 20 grams per day in females or 30 grams per day in males
8. Presence of ascites or hepatic encephalopathy
9. Symptomatic gastroparesis
10. Uncontrolled diabetes, as defined by a HgbA1C \>11%
11. Uncontrolled congestive heart failure
12. Active infections
13. Child Turcotte Pugh score \> 6
14. MELD score \>12
15. Unwilling to undergo an MRI or have contraindications to an MRI

Primary outcomes:
measure: Blood chemistry to assess for liver de-compensation events
timeFrame: Blood chemistry tests will be assessed at the initial visit.
measure: Blood chemistry to assess for liver de-compensation events
timeFrame: Blood chemistry tests will be assessed at the study visits between weeks 5 and 14.
measure: Blood chemistry to assess for liver de-compensation events
timeFrame: Blood chemistry tests will be assessed at the Week 16 visit.
measure: Adverse events
timeFrame: All participants will be monitored at the study visits between weeks 5 and 14 and all participants will be instructed to alert the study team for additional information if such an event occurs.
measure: Adverse events
timeFrame: All participants will be monitored at the week 16 visit and all participants will be instructed to alert the study team for additional information if such an event occurs.
measure: Tolerability of the ketogenic diet
timeFrame: The POMS 40 questionnaire is administered at the initial visit.
measure: Tolerability of the ketogenic diet
timeFrame: The POMS 40 questionnaire is administered at the study visits between weeks 1 and 4.
measure: Tolerability of the ketogenic diet
timeFrame: The POMS 40 questionnaire is administered at the Week 16 visit.
Secondary outcomes:
measure: MRI with proton density fat fraction (PDFF)
timeFrame: Performed at initial visit and at week 16 visit
measure: Weight loss and change in body composition
timeFrame: Performed at initial visit and at week 16 visit
measure: Changes in liver stiffness and steatosis
timeFrame: Performed at initial visit and at week 16 visit
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University
name: Raj Vuppalanchi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: