Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blood chemistry to assess for liver de-compensation events
研究概览
简要总结
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.
详细描述
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®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
While this is an open label study, the principal investigator will be blinded to the results of efficacy outcomes such as MRI-PDFF, Body composition data, VCTE by FibroScan® and study questionnaires.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NASH cirrhosis (criteria in Appendix 1) with obesity (BMI >30 kg/m2).
- •Age 18 and greater
排除标准
- •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or plan to become pregnant prior to the study date; female subjects who become pregnant during the study will be withdrawn from the study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
研究组 & 干预措施
Ketogenic diet
For participants randomized to the ketogenic diet arm, a consultation with the providers of medically supervised weight loss clinic of Indiana University Health will be arranged. Subjects will be educated on the concepts of ketosis, symptoms associated with it, and dietary manipulation to achieve ketosis. Participants in this arm will use the suggested recipes in combination with strict carbohydrate monitoring though checking for urine ketone bodies. These recipes were gathered and vetted by the dietitian at the medically supervised weight loss clinic. We anticipate that this approach will allow for more calorie intake and easier carbohydrate restriction. The follow up visits will be determined by the providers of the medically supervised weight loss clinic based on the symptoms reported and subject's compliance with carbohydrate restriction.
干预措施: Dietary consult for participants in the ketogenic diet arm (Other)
Standard of Care
For participants randomized to this arm, a consultation with the providers of medically supervised weight loss clinic will be arranged. The discussion will focus on portion control using a balanced diet. A follow up visit will be at 16 weeks. This is the extent of interventions received for participants in this arm.
干预措施: Dietary consult for participants in the standard of care arm (Other)
结局指标
主要结局
Blood chemistry to assess for liver de-compensation events
时间窗: Blood 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 events
时间窗: Blood 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.
Adverse events
时间窗: 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.
All participants will be monitored for adverse events and/or serious adverse events throughout the duration of the trial.
Tolerability of the ketogenic diet
时间窗: The 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 diet
时间窗: The 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.
Blood chemistry to assess for liver de-compensation events
时间窗: Blood 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 events
时间窗: 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.
All participants will be monitored for adverse events and/or serious adverse events throughout the duration of the trial.
Tolerability of the ketogenic diet
时间窗: The 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.
次要结局
- Weight loss and change in body composition(Performed at initial visit and at week 16 visit)
- MRI with proton density fat fraction (PDFF)(Performed at initial visit and at week 16 visit)
- Changes in liver stiffness and steatosis(Performed at initial visit and at week 16 visit)
研究者
Raj Vuppalanchi
Professor of Medicine
Indiana University