TrialX
Image

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

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

Recruiting
18 years and older
All
Phase N/A

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.

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

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or plan to become pregnant prior to the study date; female subjects who become pregnant during the study will be withdrawn from the study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

Study details
    Cirrhosis
    NASH - Nonalcoholic Steatohepatitis

NCT04383951

Indiana University

16 February 2024

Step 1 Get in touch with the nearest study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.