Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatments low fat- low glycemic index meal, mufa- low glycemic index meal, safa- low glycemic index meal, low fat- high glycemic index meal, mufa- high glycemic index meal, safa- high glycemic index meal
Sponsor Federico II University
Start date June 2014
End date December 2014
Trial size 14 participants
Trial identifier NCT02330939, 980/14

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
Participants consumed a meal with low glycemic index and poor in fat
low fat- low glycemic index meal
(Experimental)
Participants consumed a meal with low glycemic index and rich in MUFA
mufa- low glycemic index meal
(Experimental)
Participants consumed a meal with low glycemic index and rich in SAFA
safa- low glycemic index meal
(Active Comparator)
Participants consumed a meal with high glycemic index and low in fat
low fat- high glycemic index meal
(Experimental)
Participants consumed a meal with high glycemic index and rich in MUFA
mufa- high glycemic index meal
(Experimental)
Participants consumed a meal with high glycemic index and rich in SAFA
safa- high glycemic index meal

Primary Outcomes

Measure
postprandial incremental glucose AUC
time frame: 6 hours

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: -Type 1 diabetes treated by insulin pump Exclusion Criteria: - Pregnancy - Celiac disease

Additional Information

Official title Impact of Fats And Carbohydrates Quality on Postprandial glycemIc Response in People With Type 1 diabEtes on Insulin Pump (FACILE Study)
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Federico II University.