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临床试验/NCT00829569
NCT00829569已完成不适用

Effects of Marine n-3 Fatty Acid Infusion on Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes

St. Olavs Hospital2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2004年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
2
主要终点
insulin sensitivity

研究概览

简要总结

The purpose of this experimental study is to investigate whether an acute lipid infusion added marine n-3 fatty acids produces effects on insulin sensitivity in subjects with type 2 diabetes, when compared with an acute lipid infusion without marine n-3 fatty acids. Furthermore other effects on intermediary metabolism are tested for.

详细描述

Evidence indicates that n-3 fatty acids exert several beneficial effects. However, the effects of marine n-3 fatty acids on intermediary metabolism have not been completely elucidated. In a previous study of a high intake of marine n-3 fatty acids during 9 wk we demonstrated reduced insulin sensitivity and altered proportion of carbohydrate vs. fat oxidation in subjects with type 2 diabetes. These results question the use of high doses of n-3 supplements in type 2 diabetes. It is not known to what extent such effects in type 2 diabetes can be reproduced by intravenous administration of n-3 fatty acids and/or whether short term intravenous administration has other effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes defined by clinical criteria and by absence of antibodies to glutamic acid decarboxylase.
  • HbA1c 5,5 - 8,5 %
  • Blood pressure ≤ 170 mm Hg systolic and/or ≤ 105 mm Hg diastolic

排除标准

  • insulin treatment
  • hypertriglyceridemia (> 2,1 mmol/l TG)
  • proliferative retinopathy, renal insufficiency (Se-Creatinine > 150 μmol/l)
  • alcoholism, congestive heart failure or other serious diseases affecting the possibility of the subject to participate
  • supplement with fish oil or marine n-3 fatty acids during the last 6 months before baseline
  • Dicumarol treatment
  • allergy to soya, fish or egg
  • pregnancy or lactation

结局指标

主要结局

insulin sensitivity

时间窗: 4 hours

次要结局

  • n-3 fatty acid distribution(4 hours)
  • insulin secretion(4 hours)
  • energy metabolism(4 hours)
  • oxidative stress(4 hours)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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