Clinical trial NCT02442024: Metabolic Effects of the Manipulation of Nutrient Sequence in the Main Meals in Type 2 Diabetic Patients
Official title: Metabolic Effects of the Manipulation of Nutrient Sequence in the Main Meals in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
diet
nutrient sensing
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline fructosamine after 1 and 2 months of diet
timeFrame: 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 outcomes:
measure: Change from baseline fasting plasma glucose after 1 and 2 months of diet
timeFrame: 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: Change from baseline glycated hemoglobin after 1 and 2 months of diet
timeFrame: 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: Change from baseline weight after 1 and 2 months of diet adipose tissue location
timeFrame: 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: Change from baseline adipose tissue location after 1 and 2 months of diet
timeFrame: 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: Change from baseline lipid profile after 1 and 2 months of diet
timeFrame: 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)
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: PI
Study officials:
affiliation: Azienda Ospedaliero, Universitaria Pisana
name: Andrea Natali, Professor
role: STUDY_CHAIR
References: