Paleolithic Diet in the Treatment of Diabetes Type 2 in Primary Health Care

This study has been completed.
Sponsor:
Information provided by:
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT00435240
First received: February 13, 2007
Last updated: May 13, 2008
Last verified: May 2008
  Purpose

There is uncertainty about the optimal diet in the prevention and treatment of diabetes type 2. Earlier studies have generally focused on intakes of fat, protein, carbohydrate, fiber, fruit and vegetables. This study is based on another approach which compares foods that were available during human evolution with more recently introduced ones. The basic tenet from evolutionary biology is that if human physiology is less adapted to a relatively recently introduced diet based on agriculture, this could cause disturbances to human physiology and ultimately lead to diseases. Epidemiological studies indicates that diabetes mellitus type 2 is absent or near absent in populations eating a Palaeolithic ("Old Stone Age") diet which is free from food items produced in agriculture or the food industry. Our study hypothesis is that a Palaeolithic diet is better than the standard diabetes diet recommended today in treating diabetes type 2.

Fifteen patients with diabetes type 2 have been randomized to

  1. a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts
  2. a standard diabetes diet as recommended by national health authorities.

The patients eat the diet they have been randomized to for three months and then switches to the other diet for another three months. The study is conducted in Primary Health Care stations.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Behavioral: Paleolithic diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Lund University Hospital:

Primary Outcome Measures:
  • area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months
  • area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months
  • HbA1C at baseline, 3 months and 6 months
  • weight at baseline, 3 months and 6 months
  • waist circumference at baseline, 3 months and 6 months

Secondary Outcome Measures:
  • satiation measured on visual semi-analogous scale at food intake during 4 days av 6 weeks and 12 weeks
  • leptin at baseline, 3 months and 6 months
  • fasting plasma glucose at baseline, 3 months and 6 months
  • fasting plasma insulin at baseline, 3 months and 6 months
  • Systolic and diastolic blod pressure at baseline, 3 months and 6 months
  • Blood lipids at baseline, 3 months and 6 months
  • C-reactive protein at baseline, 3 months and 6 months

Enrollment: 13
Study Start Date: January 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with capacity to perform study
  • Diabetes Mellitus Type 2
  • C-peptide > 0
  • HbA1C >5.5
  • Unchanged diabetes treatment during last 3 months
  • Weight and HbA1C varied less than 5% during last 3 months
  • No acute heart disease during last 6 months
  • Unchanged treatment with betablocker last 6 months
  • Unchanged treatment with thyroid hormone substitution last 6 months

Exclusion Criteria:

  • Treatment with insulin
  • Chronic treatment with steroids (not inhaled)
  • Treatment with Waran (anticoagulant cumarin type)
  • Creatinin > 130 micromol/L
  • Elevated liver enzymes (ALAT,ASAT,ALP or GT > 4 X upper reference value)
  • Acute heart disease
  • Changed treatment with betablocker or thyroid hormone substitution
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435240

Locations
Sweden
Lund University Hospital
Lund, Skåne, Sweden, 22185
Sponsors and Collaborators
Lund University Hospital
Investigators
Principal Investigator: Tommy Jönsson, MD Department of Clinical Sciences, Lund University, Lund Sweden
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Tommy Jönsson, Department of Clinical Sciences, Medical Faculty, Lund University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT00435240     History of Changes
Other Study ID Numbers: H4 726/2004
Study First Received: February 13, 2007
Last Updated: May 13, 2008
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014