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临床试验/NCT00622960
NCT00622960已完成1 期

Comparison of High Monounsaturated Fat and High Carbohydrate Diets on Glycemic Control and Cardiovascular Risk Factors in Type 2 Diabetes

University of Cincinnati2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2004年4月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
124
试验地点
2
主要终点
body weight

研究概览

简要总结

The purpose of this proposed randomized, controlled trial is to compare the effects of high monounsaturated fat diets and high carbohydrate diets on body weight, body composition, glycemic control, plasma lipids, and other cardiovascular risk factors over a period of one year. At present, no such studies of free-living subjects have been performed. The specific aims of the proposed project are to test the hypotheses that (1) a high monounsaturated fat diet will produce greater weight loss/body fat loss and more successful weight maintenance than a high carbohydrate diet and (2) a high monounsaturated fat diet will result in an improved lipid profile and better glycemic control than a high carbohydrate diet.

详细描述

The incidence of type 2 diabetes has increased steadily over the last three decades. Although medical nutrition therapy is an integral component of diabetes management, nutrition recommendations for diabetes have often been based on clinical experience and expert consensus, rather than on carefully controlled clinical trials. The expert consensus on medical nutrition therapy is that carbohydrate and monounsaturated fat together should provide approximately 60-70% of total energy intake. This recommendation accommodates parties on both sides of a debate over what constitutes the optimal macronutrient composition of a diet for type 2 diabetic patients. On one side are proponents of high carbohydrate, low fat diets who contend that this regimen promotes the lowering of total- and LDL-cholesterol and is less calorically dense than diets containing a higher percentage of fat. On the other side are advocates of high monounsaturated fat, Mediterranean-type diets who cite data from short-term studies indicating that this approach decreases postprandial levels of plasma glucose, insulin, and triglycerides, and increases HDL-cholesterol more than isocaloric high carbohydrate diets. However, there is concern about the potential for high fat diets to increase energy intake and weight gain among free-living subjects. To make definitive, scientifically-based diet recommendations, it is essential that controlled long-term trials be conducted to demonstrate the health effects of specific percentages of monounsaturated fats and carbohydrates in the diets of persons with type 2 diabetes.

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
Single (Outcomes Assessor)

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

  • BMI of 27-40 kg/m2
  • 30-75 years of age
  • Stable body weight for the preceding 6 months
  • Diagnosis of type 2 diabetes for at least 6 months prior to enrollment
  • HbA1c of 6.5 to 9.0
  • Treatment by diet or oral agents only

排除标准

  • Pregnancy or lactation
  • Active cardiac, pulmonary, renal, liver, or gastrointestinal disease
  • Untreated thyroid disease or hypertension
  • Hypertriglyceridemia with levels of TG > 500 mg/dl
  • Use of insulin
  • Use of specific medications that may alter lipid or glucose metabolism (other than the statins)
  • Use of medications that commonly cause significant alterations in body weight (e.g., corticosteroids).

结局指标

主要结局

body weight

时间窗: prior to and after 4, 8, and 12 months of dieting

次要结局

  • blood lipid profile(prior to and after 4, 8, and 12 months of dieting)
  • glycemic control (glucose, insulin, and HbA1c)(prior to and after 4, 8, and 12 months of dieting)
  • body fat(prior to and after 4, 8, and 12 months of dieting)
  • blood pressure(prior to and after 4, 8, and 12 months of dieting)

研究者

申办方类型
Other

研究点 (2)

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