Diabetes Mellitus
Conditions
Keywords
diabetes mellitus, diet, nutrient sensing
Brief summary
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
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.
Interventions
BEHAVIORALModified Diet
Two months of a diet in which the ingestion of protein and lipid precedes that of carbohydrates.
BEHAVIORALStandard Diet
Two months of a diet in which the ingestion of protein and lipid follows that of carbohydrates.
Sponsors
Azienda Ospedaliero, Universitaria Pisana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline fructosamine after 1 and 2 months of diet | 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) | Fructosamine will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline fasting plasma glucose after 1 and 2 months of diet | 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) | Fasting plasma glucose will be measured. |
| Change from baseline glycated hemoglobin after 1 and 2 months of diet | 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) | Glycated hemoglobin will be measured. |
| Change from baseline weight after 1 and 2 months of diet adipose tissue location | 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) | Waist circumference and hip circumference will be measured. |
| Change from baseline adipose tissue location after 1 and 2 months of diet | 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) | Weight, waist circumference and hip circumference will be measured. |
| Change from baseline lipid profile after 1 and 2 months of diet | 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) | Lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) will be measured. |
Countries
Italy
Contacts
Primary ContactAndrea Natali, Professor
Backup ContactDomenico Trico, Dr
Outcome results
None listed