Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus |
Other: Paleolithic diet Other: ADA ( American Diabetes Association) recommended diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Paleolithic Diets and Metabolic Control in Type 2 Diabetes Mellitus |
- decreased insulin secretion [ Time Frame: 2 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Subjects will be placed on Paleolithic diet and markers of insulin resistance, lipid profiles and vascular reactivity will be measured.
|
Other: Paleolithic diet
diet
|
|
Active Comparator: 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.
|
Other: ADA ( American Diabetes Association) recommended diet
diet
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Shelley McCoy | 4153539087 | shmccoy@medicine.ucsf.edu |
| Contact: Lynda Frassetto, MD | 4154766143 | frassett@gcrc.ucsf.edu |
| United States, California | |
| University of California San Francisco | Recruiting |
| San Franciscco, California, United States, 94143 | |
| Contact: Umesh Masharani, MD 415-353-2664 Umesh.Masharani@ucsf.edu | |
| Contact: Lynda Frassetto, MD 415 476-6143 frassett@gcrc.ucsf.edu | |
| Principal Investigator: Umesh Masharani, MD | |
| Principal Investigator: | Franca Angeli, MD | University of California, San Francisco |
| Principal Investigator: | Umesh Masharani, MRCP | University of California, San Francisco |
| Principal Investigator: | Lynda Frassetto, MD | University of California, San Francisco |
| Study Director: | Shelley MCCoy | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00548782 History of Changes |
| Other Study ID Numbers: | H84763129001 |
| Study First Received: | October 22, 2007 |
| Last Updated: | October 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013