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临床试验/NCT00419497
NCT00419497已完成2 期

Paleolithic Diet in the Treatment of Glucose Intolerance

Lund University Hospital2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2003年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
29
试验地点
2
主要终点
change in weight and waist circumference

研究概览

简要总结

The purpose of this study is to determine whether a paleolithic diet improves glucose tolerance and insulin sensitivity in people with coronary heart disease and impaired glucose tolerance.

详细描述

There is uncertainty about the optimal diet in the prevention and treatment of glucose intolerance and diabetes type 2, disorders which are very common in patients with coronary heart disease (CHD). Earlier studies have generally focused on intakes of fat, carbohydrate, fiber, fruit and vegetables. Another approach compares foods that were available during human evolution with more recently introduced ones. Twenty-nine CHD patients with glucose intolerance or diabetes have been randomized to 1) a Paleolithic ("Old Stone Age") diet (n=14) based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts, or 2) a Consensus (Mediterranean-like) diet (n=15) based on whole grains, low-fat dairy products, vegetables, fruit, fish, and oils and margarines generally assumed to be healthy. Primary outcome variables are changes during 12 weeks in weight, waist circumference, and area under the curve for glucose (AUC Glucose0-120) and insulin (AUC Insulin0-120) at the oral glucose tolerance test.

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
None

入排标准

性别
Male
接受健康志愿者

入选标准

  • Hyperglycemia
  • Coronary Heart Disease
  • Increased waist circumference

排除标准

  • Body mass index <20 kg/m2
  • Serum creatinine >130 µmol/L
  • Poor general condition
  • Unwillingness/inability to prepare food at home (by study participant or partner)
  • Participation in another medical trial
  • Chronic inflammatory bowel disease
  • Drug treatment with hypoglycemic agents
  • Drug treatment with warfarin
  • Drug treatment with oral steroid

结局指标

主要结局

change in weight and waist circumference

时间窗: 12 weeks

area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test

时间窗: 12 weeks

area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test

时间窗: 12 weeks

次要结局

  • fasting plasma insulin(12 weeks)
  • 120-min plasma glucose(12 weeks)
  • fasting plasma glucose(12 weeks)
  • 30-min plasma glucose(12 weeks)
  • 30-min plasma insulin(12 weeks)
  • 120-min plasma insulin(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Staffan Lindeberg

Ass prof

Lund University Hospital

研究点 (2)

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