Alimentation and Diabetes in Lanzarote - ADILAN: a Pilot Trial

Study Overview
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Brief Summary
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The purpose of this study is to compare two healthy diets (according to official Spanish guidelines) that have been shown to be effective in the treatment of type 2 diabetes in order to see if one is better than the other. Another goal is to test the hypothesis that food choice has metabolic effects that are independent of macro/micronutrient composition, fiber content, glycemic load and weight loss in the treatment of type 2 diabetes.

Detailed Description
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There is some uncertainty with respect to the optimal dietary treatment of type 2 diabetes. In addition to energy balance, macronutrient composition, dietary fiber and glycemic load, increasing evidence suggests that the direct endocrine effects of food may be important. In this trial, the intervention is based on two diets. The healthy diet with grains and dairy is based on whole grains, low-fat dairy, fish, shellfish, fruit, vegetables, legumes, eggs, nuts and refined vegetable oils rich in monounsaturated fatty acids (this is called healthy diet A). The healthy diet without grains and dairy is based on fish, shellfish, lean meat, fruit, vegetables, root vegetables, eggs and nuts, but excludes grains, legumes, refined vegetable oils, dairy products and salt (this is called healthy diet B). Both diets were classified as very healthy using validated nutritional software, and are considered healthy regarding macronutrient composition, fiber, mineral and vitamin intake according to the official Spanish dietary guidelines. The macro and micronutrient ratios, fiber content and glycemic load in healthy diet A and healthy diet B have been set to be equal. The goal is to include 15 patients (>18 years) with medical diagnosis of type 2 diabetes, with or without medication, and increased waist circumference (≥80 cm for women and ≥94 cm for men), to a cross-over trial during two periods of 4-weeks separated by a 6-week washout period. Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of meals will be eaten at home according to specific directions. The working hypothesis of this study is that food choice has beneficial effects on the control of glucose beyond macro/micronutrient composition, fiber content, glycemic load and weight loss. This study will provide information on whether food choice and diet quality has greater impact than macro/micronutrient composition, fiber content, glycemic load and weight loss in glucose control in patients with type 2 diabetes, and the need to conduct a long-term trial testing our hypothesis.

Official Title
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Alimentation and Diabetes in Lanzarote - ADILAN: a Randomized Cross-over Pilot Trial Comparing a Healthy Diet With Grains and Dairy to a Healthy Diet Without Grains and Dairy in Patients With Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Healthy diet A
* Behavioral: Healthy diet B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical diagnosis of type 2 diabetes Increased waist circumference (≥80 cm for women and ≥94 cm for men) Unaltered medical diabetes treatment since three months before start of study Stable weight (varied less than 5%) since three months before start of study HbA1c ≥6.0% Exclusion Criteria: Creatinine >130 μmol/L Change of treatment with betablocker last 3 months Change of treatment with thyroid hormone substitution last 3 months Treatment with anticoagulant medication Oral or injected steroid treatment Elevated liver enzymes (AST, ALT, ALP, GPT > 4 times their respective upper reference value) Physical or psychical illness, or changes in personal circumstances that make it impossible for the patient to continue in the study

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet A<br>Healthy diet with grains and dairy | Behavioral: Healthy diet A<br>* Healthy diet A will include fruit, vegetables, fish, shellfish, lean meat, nuts, eggs and olive oil. Macro/micronutrient composition, fiber intake and glycemic load will not differ from healthy diet B. Healthy diet A will include substantial amounts of whole grains, low-fat dairy and legumes (this is called healthy diet with grains and dairy). This diet is classified as very healthy using validated nutritional software. It is in accordance with official Spanish dietary recommendations for people with diabetes type 2 regarding macronutrient composition, dietary fiber, minerals and vitamins.<br>|
| Active Comparator: Diet B<br>Healthy diet without grains and dairy | Behavioral: Healthy diet B<br>* Healthy diet B will include fruit, vegetables, fish, shellfish, lean meat, nuts, eggs and olive oil. Macro/micronutrient composition, fiber intake and glycemic load will not differ from healthy diet A. Healthy diet B will exclude grains, legumes and dairy, which will largely be replaced by root vegetables, vegetables and fruit, and slightly more lean meat, fish and nuts (this is called healthy diet without grains and dairy). Salt intake will be lower in healthy diet B. This diet is classified as very healthy using validated nutritional software. It is in accordance with official Spanish dietary recommendations for people with diabetes type 2 regarding macronutrient composition, dietary fiber, minerals and vitamins.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting fructosamine |  | Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks | 
| Fasting glucagon |  | Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve for glucose (AUC glucose0-120) at the oral glucose tolerance test |  | Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks | 
| Area under the curve for glucagon (AUC glucagon0-120) at the oral glucose tolerance test |  | Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks | 
| Fasting plasma glucose |  | Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks | 
| Total cholesterol |  | Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks | 
| Low-density lipoprotein (LDL) cholesterol |  | Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks | 
| High-density lipoprotein (HDL) cholesterol |  | Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks | 
| Triglycerides |  | Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks | 
| Systolic and diastolic blood pressure |  | To be assessed at baseline and after 4, 10 and 14 weeks | 
| High-sensitive C-reactive protein |  | Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks | 
| Waist circumference |  | To be assessed at baseline and after 4, 10 and 14 weeks | 
| Hip circumference |  | To be assessed at baseline and after 4, 10 and 14 weeks | 
| Sagittal abdominal diameter |  | To be assessed at baseline and after 4, 10 and 14 weeks | 
| Tricipital, bicipital, suprailiac and subscapular skinfold thickness |  | To be assessed at baseline and after 4, 10 and 14 weeks | 
| Satiation measured on a likert scale at food intake during 4 consecutive days |  | To be assessed at baseline and after 4, 10 and 14 weeks | 
| Quality of life using a validated spanish version of the SF-36 questionnaire |  | To be assessed at baseline and after 4, 10 and 14 weeks | 
| Change in medication |  | To be assessed at baseline and after 4, 10 and 14 weeks | 
| Body weight |  | To be assessed at baseline and after 4, 10 and 14 weeks | 
| Fasting HbA1c |  | Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus type 2, Cereals, Dairy, Dietary carbohydrates, Dietary fiber, Food, Metabolic syndrome, Satiety