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临床试验/NCT00371982
NCT00371982终止不适用

Effect of Fish Oil on Adiposity and Atherogenic Factors in Type 2 Diabetic Women

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2002年12月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
2
主要终点
The effect of 2 month treatment on:

研究概览

简要总结

  1. whether the intake of n-3 PUFA has additional effects on insulin sensitivity and adiposity (total fat mass and adipocyte morphology and function) in T2D women.
  2. n-3 PUFA supplementation might influence inflammatory genes expression in the adipose tissue of T2D patients.

详细描述

Thus, the present study was designed to evaluate the effects of n-3 PUFAs dietary supplementation on lipid and glucose homeostasis and to address the impact of this treatment on adiposity and adipose tissue gene expression in T2D women.A total of 27 T2D women (BMI 27-35kg/m², age 40-60 y) were randomly allocated to two months of 3 g/day of either fish oil (1.8 g n-3 PUFA) or placebo (paraffin oil), in a double-blind parallel design.

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

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Type 2 diabetic postmenopausal women
  • glycaemia of 7.87-14.0 mmol/l, HbA1c of 7 to 10.5%
  • plasma triglycerides between 1.72-4.6 mmol/l,
  • aged between 40 -60,
  • BMI: 27-40 kg/m2
  • able to swallow tablets

排除标准

  • patients with abnormal renal, hepatic and thyroid functions as determined by physical examination, blood cell count and standard blood biochemical profile
  • patients with gastrointestinal disorders
  • patients treated with thiazolidinediones or insulin

结局指标

主要结局

The effect of 2 month treatment on:

adiposity (total fat mass, adipocyte morphology), atherogenic markers and insulin sensitivity

次要结局

  • the underlying mechanisms of the observed results and tried to define new targets of fish oil metabolic effects
  • and the impact of fish oil on systemic inflammatory markers and adipose tissue inflammatory genes.

研究者

申办方类型
Other

研究点 (2)

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