Metabolic Effects of the Manipulation of Nutrient Sequence in the Main Meals in Type 2 Diabetic Patients
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change from baseline fructosamine after 1 and 2 months of diet
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Change from baseline fructosamine after 1 and 2 months of diet
Time Frame: 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 Outcomes
- 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))
- 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))
- 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))
- 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))
- 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))
Investigators
Andrea Natali
Professor
Azienda Ospedaliero, Universitaria Pisana