跳至主要内容
临床试验/NCT01241474
NCT01241474已完成不适用

Chronic Long-chain n-3 PUFA Supplement and Insulin Action in Human Subjects With Impaired Glucose Regulation

University of Aberdeen2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Change in insulin sensitivity assessed by hyperinsulinemic-euglycemic-eu-aminoacidemic clamp

研究概览

简要总结

The purpose of this study is to determine whether a prolonged (9 month) high (6g/d) of marine oil improves insulin sensitivity and glucose control in subjects with impaired glucose regulation.

详细描述

The incidence of Type 2 diabetes is related both to age and obesity. The disease impacts on quality of life and treatments represent a major health cost. Prevention or delayed onset of the disease remains a key target. Animal studies have shown that provision of high amounts of fish oil in the diet improves insulin sensitivity but human trials have proved equivocal. Recent dose-response trials in animals have shown the improved insulin sensitivity only occurs when the proportion of n-3 long chain polyunsaturated fatty acids (n-3 PUFA), docosahexaenoic acid and eicosapentaenoic acid, exceeds 14% of the total phospholipid fraction within tissue cell membranes. To achieve such values in humans would require a high dose of n-3 PUFA supplied over a prolonged period of time. This is tested within the current study where a daily dose of 6 g day of fish oil (containing a total of 3g docosahexaenoic acid plus eicosapentaenoic acid) is supplied for 9 months. As well as improving control of glycemia increased insulin sensitivity may also enhance protein metabolism and reduce the impact of frailty in older subjects.

研究设计

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

入排标准

年龄范围
40 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and post-menopausal women aged 40-65 years
  • Recruited from the surrounding community of Aberdeen
  • Insulin resistance with either
  • venous plasma fasting glucose > 5.0, < 7.0 mmo/l,
  • venous plasma 2-h 75-g OGTT > 5.0, < 11.1 mmol/l
  • newly diagnosed with type 2 diabetes; must be asymptomatic and detected during our screenings and not require oral hypoglycemic or insulin therapy, HbA1c < 7.0%

排除标准

  • Diabetes requiring oral hypoglycemic therapy or insulin
  • Treatment with anticoagulants, regular steroids or non-steroidal anti-inflammatory drug treatment, tricyclic antidepressants, anti-arrhythmics
  • Hepatic failure
  • Renal failure
  • Significant respiratory disease
  • Cardiovascular disease
  • Malignancy
  • Thromboembolic or coagulation disorders
  • Alcoholism or other substance misuse
  • Eating disorders or significant psychiatric disorders

结局指标

主要结局

Change in insulin sensitivity assessed by hyperinsulinemic-euglycemic-eu-aminoacidemic clamp

时间窗: 0 months and 9 months

次要结局

  • Change in amount of docosahexaenoic acid and eicosapentaenoic acid incorporated into phospholipid fraction of red blood cell membranes(at monthly intervals between 0 and 9 months)
  • Change in plasma inflammatory markers(0, 4 and 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Effect of Fish Oil on Insulin Sensitivity | 临床试验