Fats And Carbohydrates Quality on Postprandial glycemIc Response in Type 1 Diabetes (FACILE)

January 2, 2015 updated by: rivellese angela, Federico II University

Impact of Fats And Carbohydrates Quality on Postprandial glycemIc Response in People With Type 1 diabEtes on Insulin Pump (FACILE Study)

The purpose of this study is to determine whether dietary fats may affect postprandial glycemic response differently according to their quality, and these effects may differ whether they are assumed in the context of meals with high or low glycemic index in patients with type 1 diabetes. This interaction between quality of fat and glycemic index of carbohydrates may have clinical implication for the calculation of prandial insulin dose in these patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Department of Clinical Medicine and Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Type 1 diabetes treated by insulin pump

Exclusion Criteria:

  • Pregnancy
  • Celiac disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low fat- Low glycemic index
Participants consumed a meal with low glycemic index and poor in fat
Other: Low fat- Low glycemic index meal
Experimental: MUFA- Low glycemic index
Participants consumed a meal with low glycemic index and rich in MUFA
Other: MUFA- Low glycemic index meal
Experimental: SAFA- Low glycemic index
Participants consumed a meal with low glycemic index and rich in SAFA
Other: SAFA- Low glycemic index meal
Active Comparator: Low fat- High glycemic index
Participants consumed a meal with high glycemic index and low in fat
Other: Low fat- High glycemic index meal
Experimental: MUFA- High glycemic index
Participants consumed a meal with high glycemic index and rich in MUFA
Other: MUFA- High glycemic index meal
Experimental: SAFA- High glycemic index
Participants consumed a meal with high glycemic index and rich in SAFA
Other: SAFA- High glycemic index meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postprandial incremental glucose AUC
Time Frame: 6 hours
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

January 1, 2015

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimate)

January 5, 2015

Study Record Updates

Last Update Posted (Estimate)

January 5, 2015

Last Update Submitted That Met QC Criteria

January 2, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 980/14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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