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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02442024
• Other study ID #: CEPPO
• Status: Recruiting
• Phase: N/A
• First received: May 7, 2015
• Last updated: May 8, 2015
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: Andrea Natali, Professor
• Phone: +39050992814
• Email: andrea.natali[@]med.unipi.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Modified Diet
Two months of a diet in which the ingestion of protein and lipid precedes that of carbohydrates.
• Standard Diet
Two months of a diet in which the ingestion of protein and lipid follows that of carbohydrates.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa	PI

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	Change from baseline glycated hemoglobin after 1 and 2 months of diet	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No