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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: Low fat- Low glycemic index meal
* Other: MUFA- Low glycemic index meal
* Other: SAFA- Low glycemic index meal
* Other: Low fat- High glycemic index meal
* Other: MUFA- High glycemic index meal
* Other: SAFA- High glycemic index meal


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postprandial incremental glucose AUC |  | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postprandial glycemia, Momounsaturated fatty acids, Saturated fatty acids, Glycemic index, Glycemic load, Sensor augmented pump system