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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Modified Diet; Behavioral: Standard Diet

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Natali, Professor; Phone Number: +39050992814; Email: andrea.natali@med.unipi.it
• Study Contact Backup: Name: Domenico Trico, Dr; Phone Number: +39050993640; Email: domenico.trico@for.unipi.it

Study Locations

• Italy
  • PI
    • Pisa, PI, Italy, 56127
      • Recruiting
      • Azienda Ospedaliero-Universitaria Pisana
      • Contact: Andrea Natali, Professor; Phone Number: 050992814; Email: andrea.natali@med.unipi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified diet; This group will follow a modified diet over a period of two months.	Behavioral: Modified Diet; Two months of a diet in which the ingestion of protein and lipid precedes that of carbohydrates.
Active Comparator: Standard diet; This group will follow a standardized diet over a period of two months.	Behavioral: Standard Diet; Two months of a diet in which the ingestion of protein and lipid follows that of carbohydrates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero, Universitaria Pisana
• Investigators: Study Chair: Andrea Natali, Professor, Azienda Ospedaliero, Universitaria Pisana

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 8, 2015
• First Posted (Estimate): May 13, 2015

Study Record Updates

• Last Update Posted (Estimate): May 13, 2015
• Last Update Submitted That Met QC Criteria: May 8, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: diet; diabetes mellitus; nutrient sensing
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: CEPPO