Metabolic Effects of the Manipulation of Nutrient Sequence in the Main Meals in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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The investigators aimed at evaluating the metabolic effects of the inversion of the typical Italian sequence of food ingestion at the main meals in type 2 diabetic patients.

Detailed Description
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An intervention group follows a modified diet over a period of two months in which the ingestion of protein and lipid happens before that of carbohydrates. A control group follows a standardized diet in which the ingestion of carbohydrates happens before that of protein and lipid. Both diets contain a reduced intake of high-glycemic index meals, saturated fatty acids, trans fatty acids and alcohol. On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet) we measure clinical and metabolic parameters (weight, waist and hip circumferences, glucose, glycated hemoglobin, fructosamine, lipid profile) to compare the effects of the two diets.

Official Title
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Metabolic Effects of the Manipulation of Nutrient Sequence in the Main Meals in Type 2 Diabetic Patients

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Modified Diet
* Behavioral: Standard Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Well-controlled type 2 diabetes HbA1c 48-58 mmol/mol (6.5-7.5%) Treatment with metformin or diet only BMI: < 35 kg/m^2 Exclusion Criteria: Autoimmune diseases, neoplasia, heart, kidney, liver or respiratory failure Pregnancy Bariatric surgery

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified diet<br>This group will follow a modified diet over a period of two months. | Behavioral: Modified Diet<br>* Two months of a diet in which the ingestion of protein and lipid precedes that of carbohydrates.<br>|
| Active Comparator: Standard diet<br>This group will follow a standardized diet over a period of two months. | Behavioral: Standard Diet<br>* Two months of a diet in which the ingestion of protein and lipid follows that of carbohydrates.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline fructosamine after 1 and 2 months of diet | Fructosamine will be measured. | On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline fasting plasma glucose after 1 and 2 months of diet | Fasting plasma glucose will be measured. | On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet) | 
| Change from baseline glycated hemoglobin after 1 and 2 months of diet | Glycated hemoglobin will be measured. | On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet) | 
| Change from baseline weight after 1 and 2 months of diet adipose tissue location | Waist circumference and hip circumference will be measured. | On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet) | 
| Change from baseline adipose tissue location after 1 and 2 months of diet | Weight, waist circumference and hip circumference will be measured. | On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet) | 
| Change from baseline lipid profile after 1 and 2 months of diet | Lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) will be measured. | On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, diet, nutrient sensing