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

Not Applicable

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Modified Diet; Behavioral: Standard Diet

• Registration Number: NCT02442024
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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 Timeline

• Study Start: 2014-01
• Status Verified: 2015-05
• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-08
• Last Update Submitted: 2015-05-08
• Study First Posted: 2015-05-13
• Last Update Posted: 2015-05-13
• Primary Completion: 2015-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified diet	Modified Diet	This group will follow a modified diet over a period of two months.
Standard diet	Standard Diet	This group will follow a standardized diet over a period of two months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, PI, Italy