TrialGlobe

Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04383951

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionNASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver

Full registry 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or plan to become pregnant prior to the study date; female subjects who become pregnant during the study will be withdrawn from the study 5.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

Treatments and study arms

Dietary consult for participants in the ketogenic diet arm

Other

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 arm

Other

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.

Primary outcomes

Blood chemistry to assess for liver de-compensation eventsBlood chemistry tests will be assessed at the initial visit.

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

Blood chemistry to assess for liver de-compensation eventsBlood chemistry tests will be assessed at the study visits between weeks 5 and 14.

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

Blood chemistry to assess for liver de-compensation eventsBlood chemistry tests will be assessed at the Week 16 visit.

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

Adverse eventsAll 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.

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

Adverse eventsAll 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.

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

Tolerability of the ketogenic dietThe POMS 40 questionnaire is administered at the initial visit.

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

Tolerability of the ketogenic dietThe POMS 40 questionnaire is administered at the study visits between weeks 1 and 4.

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

Tolerability of the ketogenic dietThe POMS 40 questionnaire is administered at the Week 16 visit.

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Indiana University School of Medicine🇺🇸 Indianapolis, Indiana, United States
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