The YMCA's Diabetes Prevention Program (YMCA's DPP) for the Treatment of Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Effect of the YMCA's Diabetes Prevention Program on NAFLD
研究概览
简要总结
This study is for men and women have been diagnosed with non-alcoholic fatty liver disease (NAFLD) and will consequently participate in the YMCA's Diabetes Prevention Program.
详细描述
This study is for men and women who participate in the YMCA's Diabetes Prevention Program (YMCA's DPP) and have been diagnosed with non-alcoholic fatty liver disease (NAFLD). There will be no administration of study drug. The purpose of this study is to see if participation in the YMCA's DPP will result in weight loss and improvement in the liver in patients with fatty liver disease.
Eligible participants will visit Weill Cornell Medical College's Gastroenterology and Hepatology clinic to review their medical history, physical examination, complete a survey, and conduct imaging tests (FibroScan, ultrasound, DEXA scan) for their baseline visit. Blood will be collected as part of standard practice. An additional blood sample will be collected for storage. Subjects will complete 9 out of 16 weekly sessions. The YMCA's program will be conducted at Weill Cornell Medical College Gastroenterology and Hepatology Division.
Participants will be in the YMCA program for about 1 year and an additional 1 year in the long-term follow-up for data collection.
Participants will be compensated for their time.
Key eligibility criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Must provide signed written informed consent and agree to comply with the study protocol
- •BMI >25 kg/m²
- •Hepatic steatosis by imaging or histology
- •Baseline Fibroscan CAP score > 238 dB/m
- •ALT >19IU/mL in females, ALT >30IU/mL in males
排除标准
- •Unclear etiology of liver disease
- •Competing etiologies for hepatic steatosis
- •Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to:
- •Positive hepatitis B surface antigen
- •Positive hepatitis C virus RNA
- •Suspicion of drug-induced liver disease
- •Alcoholic liver disease
- •Autoimmune hepatitis
- •Wilson's disease
- •Hemochromatosis
- •Primary biliary cholangitis or primary sclerosing cholangitis
- •Known or suspected hepatocellular carcinoma
- •Current or recent history (<5 years) of significant alcohol consumption. For men, significant consumption is defined as >30g of alcohol per day. For women, it is defined as >20g of alcohol per day.
- •Compensated and decompensated cirrhosis (clinical and/or histologic evidence of cirrhosis). NASH patients with fibrosis stage = 4 according to the NASH CRN fibrosis staging system are excluded.
- •Pregnant females
- •Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain
- •Inability to perform Fibroscan and/or invalid study
结局指标
主要结局
Effect of the YMCA's Diabetes Prevention Program on NAFLD
时间窗: 104 weeks from the start of the study
Determine the effect of the YMCA's Diabetes Prevention Program on NAFLD as determined by comparison of liver enzymes pre- and post- program - we'll look at the changes of ALT levels to determine the aforementioned. We will perform these diagnostic tests in order to determine the effectiveness of the 16 weeks of sessions.
Determine if Liver Fat via Fibroscan Controlled Attentuation Pattern score has decreased as a result of YMCA program
时间窗: 104 weeks from the start of the study
Evaluate the amount of liver fat as determined by Fibroscan Controlled Attenuation Pattern (CAP) score in patients with NAFLD pre- and post- participation in the diabetes prevention program with the YMCA. The CAP range should be 100-400, without any sub-scales reported. Lower values in the range represent less 'fat', making it a better score.
次要结局
- Measuring the effectiveness of the YMCA Program, as per SF-36 patient-reported questionnaires(104 weeks from the start of the study)
- Measuring the effectiveness of the YMCA Program, as per the DEXA scan(104 weeks from the start of the study)
- Measuring the effectiveness of the YMCA Program, as per each patient's BMI(104 weeks from the start of the study)
- Measuring the effectiveness of the YMCA Program, as per metabolic blood work that's analyzed(104 weeks from the start of the study)