NCT02526121已完成不适用
Effect of Therapeutic Phlebotomies on the Triglycerides Concentration in Patients With Hypertriglyceridemia and Hyperferritinemia.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Triglycerides concentration
研究概览
简要总结
The purpose of this study is to evaluate the effect of iron depletion with phlebotomies on blood triglyceride concentration, in subjects with hypertriglyceridemia and iron overload, compared with a dietary intervention alone.
All subjects in this study will follow dietary and lifestyle counseling in a period of 3 months.
A randomized group will receive phlebotomies every 3 weeks in this period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hyperferritinemia: > 300µgr/L for male and >200µgr/L for female.
- •Hypertriglyceridemia: > 200 mg/dL in two determinations after at least ten hours of fasting and lipid-lowering diet.
排除标准
- •Contraindications for phlebotomy: poor venous access, previous intolerance (hypotension or apprehension), heart disease, anemia.
- •Subjects suffering from acute or chronic disease, including liver disease, diabetes, cancer, kidney disease or uncontrolled thyroid disease.
- •Elevated C reactive protein (CRP) as a parameter of inflammation (>10mg/L).
- •Alcohol intake: over 30 gr. per day for men and 25 gr. per day for women.
- •Lipid lowering drugs use.
结局指标
主要结局
Triglycerides concentration
时间窗: Three months before
次要结局
- Iron parameters(Three months before)
研究者
Fernando Civeira
Professor
Instituto Aragones de Ciencias de la Salud
研究点 (2)
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