NCT01260246终止不适用
Sitagliptin for the Treatment of Non-alcoholic Steatohepatitis in Patients With Type 2 Diabetes.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To demonstrate improvement in liver disease (based on liver biopsy)with sitagliptin.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled trial evaluating the impact of sitagliptin therapy in patients with concomitant type 2 diabetes and non-alcoholic steatohepatitis (NASH) on improving liver disease based on biopsy results. The effect of sitagliptin on other measures such as hormones modifying insulin release and sensitivity (termed adipocytokines), fat distribution, and biomarkers of cardiovascular risk will also be evaluated.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known DM2 (receiving lifestyle management and/or metformin and/or sulfonylurea
- •Stable therapy for DM2 for the past 3 months
- •All other medications and doses stable for past 3 months
- •HbA1c 8.9% or lower (can be done in past 30 days)
- •Known NASH based on the accepted American Gastroenterological Association Criteria:
- •Alcohol consumption (< 10g/day in women and <20g/day in men)
- •Cause of liver disease other than NAFLD (negative investigations for: viral hepatitis, iron overload, a-1 antitrypsin, ceruloplasmin, autoimmune disease)
- •Liver histology demonstrating macrovesicular fatty change of hepatocytes, with evidence of steatohepatitis, manifested by the presence of Mallory Bodies, ballooning degeneration, lobular neutrophilic inflammation and perisinusoidal fibrosis. (If liver biopsy done within 2 years prior to screening for this trial, that biopsy will be reviewed to ensure it meets criteria for diagnosis).
排除标准
- •Any contraindication for undergoing MRI
- •Child class B or C cirrhosis
- •Participation in another clinical trial
- •Use of thiazoledinedione (rosiglitazone or pioglitazone) in past 6 months
- •Current use of plavix
- •Previous exposure to sitagliptin
- •Prior history of pancreatitis
- •History of anaphylaxis to another Canadian-marketed DPP-IV inhibitor (saxagliptin)
- •Creatine clearance <30 ml/min
- •Anaemia (haemoglobin < 110 mg/dL)
- •Platelet count < 50 000 cells/mm3
- •Known heart or kidney failure
- •Comorbid condition that decreases natural life span (e.g. known cancer)
- •Pregnant or breastfeeding or wishing to become pregnant in the next 6 months
- •Current or past treatment with medications that can induce steatohepatitis (e.g. glucocorticoids, methotrexate, amiodarone etc.)
研究组 & 干预措施
sitagliptin
Experimental
sitagliptin 100mg/daily for 6 months
干预措施: sitagliptin (Drug)
placebo
Placebo Comparator
placebo match for 6 months
干预措施: placebo (Drug)
结局指标
主要结局
To demonstrate improvement in liver disease (based on liver biopsy)with sitagliptin.
时间窗: 3 years
次要结局
- In individuals with NASH and DM2: To determine the correlation between changes in histology with changes in hepatic fat demonstrated by MRI and changes in fibrosis by Fibroscan.(3 years)
- In individuals with NASH and DM2: To document the impact of sitagliptin therapy on adipocytokines, inflammatory markers, non-traditional cardiovascular risk factors, adipose distribution, and dyslipidemia.(3 years)
- In individuals with NASH and DM2: To delineate the effect of sitagliptin therapy on platelet aggregation and oxidative stress.(3 years)
研究者
Tisha Joy
Assistant Professor, Division of Endocrinology
Lawson Health Research Institute
研究点 (1)
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