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)
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Quebec、加拿大、G1V 0A6
- Laval University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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实验性的:n-3 PUFAs
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5 capsules/day in order to provide 3 g/day of n-3 PUFAs.
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安慰剂比较:Corn and soybean oil pill
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5 capsules/day containing corn and soybean oil
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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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
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At the end of the two 8-week interventions
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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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
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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
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At the end of the two 8-week interventions
|
合作者和调查者
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
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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