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

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ClinicalTrials.gov Identifier: NCT02442024
Recruitment Status : Unknown
Verified May 2015 by Andrea Natali, Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was:  Recruiting
First Posted : May 13, 2015
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
Andrea Natali, Azienda Ospedaliero, Universitaria Pisana

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Modified Diet Behavioral: Standard Diet Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolic Effects of the Manipulation of Nutrient Sequence in the Main Meals in Type 2 Diabetic Patients
Study Start Date : January 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline fructosamine after 1 and 2 months of diet [ Time Frame: 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 :
  1. Change from baseline fasting plasma glucose after 1 and 2 months of diet [ Time Frame: 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.

  2. Change from baseline glycated hemoglobin after 1 and 2 months of diet [ Time Frame: 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.

  3. Change from baseline weight after 1 and 2 months of diet adipose tissue location [ Time Frame: 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.

  4. Change from baseline adipose tissue location after 1 and 2 months of diet [ Time Frame: 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.

  5. Change from baseline lipid profile after 1 and 2 months of diet [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442024


Contacts
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Contact: Andrea Natali, Professor +39050992814 andrea.natali@med.unipi.it
Contact: Domenico Trico, Dr +39050993640 domenico.trico@for.unipi.it

Locations
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Italy
Azienda Ospedaliero-Universitaria Pisana Recruiting
Pisa, PI, Italy, 56127
Contact: Andrea Natali, Professor    050992814    andrea.natali@med.unipi.it   
Principal Investigator: Andrea Natali, Professor         
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
Investigators
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Study Chair: Andrea Natali, Professor Azienda Ospedaliero, Universitaria Pisana
More Information
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Responsible Party: Andrea Natali, Professor, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier: NCT02442024    
Other Study ID Numbers: CEPPO
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by Andrea Natali, Azienda Ospedaliero, Universitaria Pisana:
diabetes mellitus
diet
nutrient sensing
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases