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

Study Overview
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Brief Summary
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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 a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts 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.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Paleolithic diet


Participation Criteria
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Eligibility Criteria
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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

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Paleolithic diet|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |