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

NCT02442024 | Unknown

• 1 other identifier: CEPPO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus; diet; nutrient sensing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Study Arms (2)

Modified diet

EXPERIMENTAL

This group will follow a modified diet over a period of two months.

Behavioral: Modified Diet

Standard diet

ACTIVE COMPARATOR

This group will follow a standardized diet over a period of two months.

Behavioral: Standard Diet

Interventions

Modified Diet BEHAVIORAL

Two months of a diet in which the ingestion of protein and lipid precedes that of carbohydrates.

Modified diet

Standard Diet BEHAVIORAL

Two months of a diet in which the ingestion of protein and lipid follows that of carbohydrates.

Standard diet

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Autoimmune diseases, neoplasia, heart, kidney, liver or respiratory failure
• Pregnancy
• Bariatric surgery

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56127, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Andrea Natali, Professor

  Azienda Ospedaliero, Universitaria Pisana

  STUDY CHAIR

Central Study Contacts

Andrea Natali, Professor

CONTACT

+39050992814; andrea.natali@med.unipi.it

Domenico Trico, Dr

CONTACT

+39050993640; domenico.trico@for.unipi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 13, 2015
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

IT (1)