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Effects of N-3 Polyunsaturated Fatty Acids On Chylomicron Secretion And Expression Of Genes That Regulate Intestinal Lipid Metabolism In Men With Type 2 Diabetes (DBB48)

2013年2月28日 更新者:Patrick Couture、Laval University

The overaccumulation of apoB-48-containing lipoproteins of intestinal origin seen in patients with type 2 diabetes are now thought to be attributable to elevated intestinal production and reduced clearance. Substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease risk. Therefore, reduction of atherogenic plasma triglyceride-rich lipoproteins (TRL) levels of intestinal origin appears to be crucial to improve CVD risk associated with type 2 diabetes. In this regard, n-3 PUFAs have been shown to exert beneficial effects on diabetic dyslipidemia. However, the investigators understanding of the physiological changes that occur with n-3 PUFA supplementation is suboptimal, thereby limiting the investigators appreciation of its impact on CVD risk associated with type 2 diabetes. The effects of n-3 PUFAs on the intestinal production of TRLs and the expression of genes regulating intestinal lipid absorption and chylomicron synthesis have not yet been examined in humans. The general objective of the proposed research is to investigate the mechanisms by which n-3 PUFAs beneficially modify intestinal lipoprotein metabolism in patients with type 2 diabetes. The investigators hypothesize that n-3 PUFA supplementation in men with type 2 diabetes will:

  • reduce TRL apoB-48 production rate and increase fractional catabolic rate of these lipoproteins,
  • decrease the expression of genes that regulate intestinal lipid absorption and synthesis as well as synthesis of apoB-48-containing lipoproteins,
  • decrease both plasma surrogates of cholesterol absorption and cholesterol synthesis.

研究概览

研究类型

介入性

注册 (实际的)

12

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Quebec、加拿大、G1V 0A6
        • Laval University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 55年 (成人)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  • age between 18 and 55 years,
  • plasma TG levels above the 50th percentile for age,
  • non-smoker,
  • BMI between 25.0 and 40.0 kg/m2,
  • stable body weight for at least 6 months prior to the study baseline,
  • HbA1c between 6.5 and 8.5%,
  • baseline fasting plasma glucose < 15.0 mmol/L
  • patients with de novo type 2 diabetes not taking oral hypoglycemic agents -- - or patients having received stable doses of metformin for at least 3 months before randomization.

Exclusion Criteria:

  • extreme dyslipidemias such as familial hypercholesterolemia,
  • patients with secondary form of diabetes or acute metabolic diabetic complications,
  • patients having received or being treated with insulin or a thiazolidinedione within the past 6 months,
  • subjects having CVD (CHD, cerebrovascular disease or peripheral arterial disease)
  • subjects taking medications known to affect lipoprotein metabolism (e.g. steroids, beta blockers, thiazide diuretics, lipid lowering agents,
  • significant alcohol intake

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:n-3 PUFAs
5 capsules/day in order to provide 3 g/day of n-3 PUFAs.
安慰剂比较:Corn and soybean oil pill
5 capsules/day containing corn and soybean oil

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change in the in vivo kinetics of intestinally derived apoB-48-containing lipoproteins between the two 8-week interventions
大体时间:At the end of the two 8-week interventions
At the end of the two 8-week interventions

次要结果测量

结果测量
大体时间
Change in the expression of genes that regulate intestinal lipid absorption (NPC1L1, ABCG5/8, FABP, SREBP-1c) and synthesis (DGAT, ACAT2, HMG CoA reductase) as well as synthesis of apoB-48-containing lipoproteins (MTP)between the two 8-week interventions
大体时间:At the end of the two 8-week interventions
At the end of the two 8-week interventions
Change in the plasma surrogates of cholesterol absorption (campesterol, beta-sitosterol) and synthesis (lathosterol) between the two 8-week interventions
大体时间:At the end of the two 8-week interventions
At the end of the two 8-week interventions

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Patrick Couture, MD, PhD, FRCP、Laval University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年4月1日

初级完成 (实际的)

2009年10月1日

研究完成 (实际的)

2013年1月1日

研究注册日期

首次提交

2011年10月6日

首先提交符合 QC 标准的

2011年10月7日

首次发布 (估计)

2011年10月10日

研究记录更新

最后更新发布 (估计)

2013年3月4日

上次提交的符合 QC 标准的更新

2013年2月28日

最后验证

2013年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • INAF-117.05.01

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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