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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified diet | Experimental | This group will follow a modified diet over a period of two months. |
|
| Standard diet | Active Comparator | This group will follow a standardized diet over a period of two months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Diet | Behavioral | Two months of a diet in which the ingestion of protein and lipid precedes that of carbohydrates. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Natali, Professor | Contact | +39050992814 | andrea.natali@med.unipi.it | |
| Domenico Trico, Dr | Contact | +39050993640 | domenico.trico@for.unipi.it |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Natali, Professor | Azienda Ospedaliero, Universitaria Pisana | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Pisana | Recruiting | Pisa | PI | 56127 | Italy |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Standard Diet | Behavioral | Two months of a diet in which the ingestion of protein and lipid follows that of carbohydrates. |
|
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) |