The University of Michigan Wellness Education for Liver Health Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction
研究概览
简要总结
The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for adults with Non-alcoholic Fatty Liver Disease (NAFLD).
详细描述
As there are no medications that effectively treat nonalcoholic fatty liver disease (NAFLD), effective diet and lifestyle treatments are imperative to curb this disease's impact. Our data suggests that insulin resistance is the strongest modifiable risk factor for having NAFLD. Additionally, genetic factors can interact with insulin resistance to multiplicatively increase risk of NAFLD. The investigators hypothesize that a very low-carbohydrate diet and behavioral support program may be able to achieve NAFLD reversal in adults with steatosis and/or mild fibrosis, especially in a subpopulation of rs738409-GG individuals. To prepare to test this, the investigators will conduct a pilot feasibility and acceptability trial of a 4-month online very low-carbohydrate, ketogenic (or keto) program in adults with NAFLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •have regular access to the internet
- •MRI with liver steatosis but nor cirrhosis
- •Able to consent and follow directions
- •No physical limitations
- •Physician approval to participate
- •Able to attend in-person appointments in Ann Arbor
- •Be identified based on information from the Michigan Genomics Initiative (MGI) database
- •have elevated liver function tests
排除标准
- •non-English speaking
- •inability to complete baseline measurements
- •a substance abuse, mental health, or medical condition that would interfere with participation (such as current chemotherapy, heart failure, kidney failure, Cushing's syndrome, etc.)
- •pregnant or planning to get pregnant in the next 6 months
- •type 1 diabetes
- •non-NAFLD causes of elevated liver function tests
- •planned or history of weight loss surgery
- •vegan or vegetarian
- •currently enrolled in a weight loss program or other investigative study that might conflict with this research
- •taking medications known to cause weight gain or loss
- •recent decompensation/hospitalization
- •metal implants/inability to receive MRI
结局指标
主要结局
Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction
时间窗: 4 months
Measured with pre and post MRIs
次要结局
- Change in Liver Stiffness(4 months)
- Body Weight Change(4 months)
研究者
Laura Saslow
Assistant Professor
University of Michigan