NCT00760760已完成2 期
Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Adipose tissue inflammation
研究概览
简要总结
Inflammation in the adipose (fat) tissue is an important condition leading to metabolic derangements and cardiovascular disease in obese patients. n-3 polyunsaturated fatty acids exert anti-inflammatory effects and prevent adipose tissue inflammation in rodent obesity. This study tests the hypothesis that n-3 polyunsaturated fatty acids ameliorate adipose tissue inflammation in morbidly obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-diabetic morbidly obese patients (BMI > 40 kg/m2) supposed to undergo bariatric surgery
- •Age 20-65 yrs
排除标准
- •Acute illness within the last two week
- •Known diabetes mellitus or current anti-diabetic medication
- •Acquired immunodeficiency (HIV infection)
- •Hepatitis or other significant liver disease
- •Severe or untreated cardiovascular, renal, pulmonary disease
- •Untreated or inadequately treated clinically significant thyroid disease
- •Active malignant disease
- •Inborn or acquired bleeding disorder including warfarin treatment
- •Pregnancy or breast feeding
- •Drug intolerability that prohibits the use of the study drug
研究组 & 干预措施
n-3 PUFA
Experimental
干预措施: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA) (Drug)
Control
Placebo Comparator
干预措施: control (Drug)
结局指标
主要结局
Adipose tissue inflammation
时间窗: Eight weeks of treatment
次要结局
- Metabolic control(Eight weeks of treatment)
- Dependence of effects on Pparg polymorphisms(Eight weeks of treatment)
研究者
Thomas M Stulnig
Associate Professor
Medical University of Vienna
研究点 (1)
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