Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis

N/AActive Not RecruitingNCT04383951

Indiana University40 enrolled

Overview

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.

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®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

NASH - Nonalcoholic Steatohepatitis Cirrhosis, Liver

Interventions

Dietary consult for participants in the ketogenic diet armOTHER

An initial consultation with the providers of medically supervised weight loss clinic will be arranged. Participants in the ketogenic diet group will be educated on the concepts of the diet and will be provided with recipes to be utilized at home that adhere to this diet. In addition to the initial consultation, participants in this arm receive additional consultations with these providers with a frequency as determined by the provider.

Dietary consult for participants in the standard of care armOTHER

For participants in the standard of care arm, an initial consultation with the providers of medically supervised weight loss clinic will be arranged and the discussion will center around portion control using a balanced diet. Participants will receive only one additional consultation with the provider 16 weeks later just prior to the conclusion of the study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Indiana University School of Medicine

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Blood chemistry to assess for liver de-compensation events

Blood will be drawn serially to assess fasting blood glucose, serum creatinine and fasting lipid profile.

Time frame: Blood chemistry tests will be assessed at the initial visit.

Blood chemistry to assess for liver de-compensation events

Blood will be drawn serially to assess fasting blood glucose, serum creatinine and fasting lipid profile.

Time frame: Blood chemistry tests will be assessed at the study visits between weeks 5 and 14.

Blood chemistry to assess for liver de-compensation events

Blood will be drawn serially to assess fasting blood glucose, serum creatinine and fasting lipid profile.

Time frame: Blood chemistry tests will be assessed at the Week 16 visit.

Adverse events

All participants will be monitored for adverse events and/or serious adverse events throughout the duration of the trial.

Time frame: 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.

Adverse events

All participants will be monitored for adverse events and/or serious adverse events throughout the duration of the trial.

Time frame: 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.

Tolerability of the ketogenic diet

How well the ketogenic diets is tolerated will be assessed by administering a POMS40 questionnaire.

Time frame: The POMS 40 questionnaire is administered at the initial visit.

Data from ClinicalTrials.gov

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Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes