Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00548782
First received: October 22, 2007
Last updated: June 20, 2013
Last verified: June 2013

October 22, 2007
June 20, 2013
September 2007
June 2013   (final data collection date for primary outcome measure)
decreased insulin secretion [ Time Frame: 2 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00548782 on ClinicalTrials.gov Archive Site
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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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Other: Paleolithic diet
    diet
  • Other: ADA ( American Diabetes Association) recommended diet
    diet
  • Active Comparator: A
    Subjects will be placed on Paleolithic diet and markers of insulin resistance, lipid profiles and vascular reactivity will be measured.
    Intervention: Other: Paleolithic 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.
    Intervention: Other: ADA ( American Diabetes Association) recommended diet
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
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June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00548782
H84763129001
No
University of California, San Francisco
University of California, San Francisco
Not Provided
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
University of California, San Francisco
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP