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
  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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • decreased insulin secretion [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: September 2007
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
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00548782

Locations
United States, California
University of California San Francisco
San Franciscco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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: June 20, 2013
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 August 21, 2014