A Cluster Randomized Trial to Determine Diagnostic and Clinical Outcomes From Enhanced SCREENing Strategies for NASH in Type 2 Diabetes (SCREEN NASH T2D)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Prevalence of presumed advanced NASH based on biochemical and FibroScan results
研究概览
简要总结
The study is stratified cluster randomized trial. The study population will include adults with T2D and presumed NASH.
详细描述
The study is a multi-centered, stratified cluster randomized controlled, open-labeled two-phase study. Clusters will be independent LMC clinic sites with patients as participants. The use of the stratified cluster randomization design will help prevent the potential for cross-contamination of screening methods.
Study participants who meet eligibility criteria undergo NASH screening. Everything, other than routineness of screening, is maintained the same in both the groups. The screening intervention received is determined by the site of the participant's provider. All participants enrolled will undergo biochemical screening. Regardless of randomization, any participants meeting biochemical cut-offs (FIB-4 index ≥1.3 or NFS >-1.455) will undergo FibroScans. Clinical data and a health-related quality of life assessment will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
The care provider is masked to the primary outcome of the study, but not masked to the intervention.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of T2D
- •Age 18 - 80 years
- •BMI >25 kg/m2 or waist circumference ≥102 cm in men and ≥88 cm in women
- •Informed consent
排除标准
- •Known history of biopsy-proven NAFLD or NASH, hepatitis B, hepatitis C, HIV, liver cirrhosis, hemochromatosis, drug-induced hepatitis, alcohol-related or autoimmune hepatic disease, history of hepatic decompensation, solid organ transplant, or primary liver cancer, based on electronic medical record
- •History of alcohol abuse (≥30 g/day or ≥3 drinks/day for males and ≥20 g/day or ≥2 drinks/day for females)
- •Unstable patients with T2D (e.g. end stage renal disease on dialysis, late stage cancer, acute cardiovascular event or any hospitalization in the past 3 months). Note - Emergency room visit without hospitalization is not exclusionary
- •Pregnancy/lactation
- •Presence of implanted electronic medical device (i.e., pacemaker, as FibroScan cannot be performed)
- •Language barriers (i.e. inability to read the consent form translated in any of the multiple languages)
结局指标
主要结局
Prevalence of presumed advanced NASH based on biochemical and FibroScan results
时间窗: 3 months
Percent of participants identified with presumed advanced NASH. Specific details for calculating the primary outcome of this study are blinded for health care providers, and therefore not disclosed in this description.
次要结局
- Proportion of study participants with a fibrosis-4 index (FIB-4) and/or NAFLD fibrosis score (NFS) above cut-off values(1 day)
- Alcohol consumption by study arm - drinks per day(1 day)
- Proportion of study participants with presumed any NASH(3 months)
- Proportion of study participants with a fibrosis and/or steatosis (stages)(1 day)
- Alcohol consumption by study arm - drinks per week(1 day)
- Health-related quality of life by study arm(1 day)
- Proportion of study participants with presumed high grade fibrosis(3 months)
- Proportion of study participants with presumed F2/F3 NASH(3 months)
- Alcohol consumption by study arm - Alcohol Use Disorders Identification Test (AUDIT) score(1 day)