Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome
Paleolithic Diets and Metabolic Control in Type 2 Diabetes Mellitus
This study proposes to evaluate the physiological effects of eating Paleolithic type diet ("hunter-gatherer's diet") on Type 2 diabetic patients. The diet essentially consists of fruits, vegetables, nuts, lean meats, excludes dairy products and grains.Subjects will be randomized into taking either ADA (American Diabetic Association) recommended diet or Paleolithic diet for 21 days. The research kitchen will provide all food items and total calories in both groups will be adjusted to maintain baseline weight. Blood and urine test will be done in the first 3 days, last 3 days and 1 month after the study period to study and compare the effects of the two diets on subjects glucose control, lipid profile and other parameters of cardiovascular physiology.
We hypothesize that a palaeolithic diet in subjects with Type 2 diabetes mellitis, will result in improvement in above parameters and lead to improvement in glucose control with less need for diabetes medicines (either lower doses or fewer medications) to a greater extent than in subjects fed with ADA diet, without any change in weight. We also expect a beneficial effect on blood vessel function, lipid profiles and blood pressure.
研究概览
详细说明
This study proposes to evaluate the physiological effects of eating Paleolithic type diet ("hunter-gatherer's diet") on Type 2 diabetic patients. The diet essentially consists of fruits, vegetables, nuts, lean meats, excludes dairy products and grains.Subjects will be randomized into taking either ADA (American Diabetic Association) recommended diet or Paleolithic diet for 21 days. The research kitchen will provide all food items and total calories in both groups will be adjusted to maintain baseline weight. Blood and urine test will be done in the first 3 days, last 3 days and 1 month after the study period to study and compare the effects of the two diets on subjects glucose control, lipid profile and other parameters of cardiovascular physiology.
We hypothesize that a palaeolithic diet in subjects with Type 2 diabetes mellitis, will result in improvement in above parameters and lead to improvement in glucose control with less need for diabetes medicines (either lower doses or fewer medications) to a greater extent than in subjects fed with ADA diet, without any change in weight. We also expect a beneficial effect on blood vessel function, lipid profiles and blood pressure.
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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California
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San Francisco、California、美国、94143
- University of California San Francisco
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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:
- Type 2 diabetic patients
- Age >= 18 yrs
- BMI < 40 kg/m2
- Normal cardiac, renal and hepatic function
Exclusion Criteria:
- Subjects on thiazolidinediones ( Avandia, Actos) or other medications that interfere with the testing procedures
- Subjects unwilling or unable to follow the diet specified
- Pregnant women
- Subjects who are unable to understand the consent form
- Hematocrit less than 30
- Patients with defibrillators
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:A
Subjects will be placed on Paleolithic diet and markers of insulin resistance, lipid profiles and vascular reactivity will be measured.
a paleolithic diet excludes dairy, grains, legumes and processed foods.
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diet
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有源比较器:B
Subjects will be placed on ADA ( American Diabetes Association) recommended diet and markers of insulin resistance, lipid profiles and vascular reactivity will be measured.
An ADA diet is lower fat and more whole grains.
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diet
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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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decreased insulin secretion
大体时间:2 months
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2 months
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合作者和调查者
调查人员
- 首席研究员:lynda frassetto, md、University of California, San Francisco
- 首席研究员:Franca Angeli, MD、University of California, San Francisco
- 首席研究员:Umesh Masharani, MRCP、University of California, San Francisco
- 研究主任:Shelley MCCoy、University of California, San Francisco
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 (实际的)
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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