NCT03011931已完成早期 1 期
Simvastatin Metabolism as a Test for Celiac Disease Activity
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Compare simvastatin metabolism with intestinal biopsies
研究概览
简要总结
To study the correlation between simvastatin metabolism by the enterocyte and the histologic state of the intestine in treated celiac disease.
详细描述
A cross sectional design incorporating subjects with active celiac disease and healed celiac disease (based on clinically-obtained biopsies); and healthy individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Gluten-free diet for at least 1 year
- •Clinical endoscopy within the past month
- •Biopsies must show no villous atrophy or villous blunting
- •Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater
排除标准
- •1st degree relative with Celiac Disease
- •Positive tTG IgA, already on simvastatin or statin agent
- •Unable to stop non-steroidal or anti-inflammatory drugs
- •Prior history of GI surgery other than appendectomy or cholecystectomy
- •Taking drugs know to inhibit or activate CYP3A4
- •Unable to avoid food known to inhibit CYP3A4
- •History of a reaction to statin drugs in the past
- •Pregnant or nursing women
研究组 & 干预措施
Simvastatin
Experimental
Simvastatin tablet, 20 mg, one time by mouth
干预措施: Simvastatin (Drug)
结局指标
主要结局
Compare simvastatin metabolism with intestinal biopsies
时间窗: Within one month of visit
次要结局
- DNA sampling(Prior to administration of simvastatin)
- Villous height and crypt depth(Within 1 month of visit)
- Dietary interview(At initial visit)
- Urinalysis(Prior to administration of simvastatin and at the 3-hour mark)
- Serologic testing(Prior to administration of simvastatin)
研究者
研究点 (1)
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