Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Paleolithic Diets and Metabolic Control in Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Paleolithic diet
* Other: ADA ( American Diabetes Association) recommended diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>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. | Other: Paleolithic diet<br>* diet<br>|
| Active Comparator: B<br>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. | Other: ADA ( American Diabetes Association) recommended diet<br>* diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreased insulin secretion |  | 2 months |