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

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
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
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type 1 Diabetes focused on measuring Postprandial glycemia, Momounsaturated fatty acids, Saturated fatty acids, Glycemic index, Glycemic load, Sensor augmented pump system

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Type 1 diabetes treated by insulin pump

Exclusion Criteria:

  • Pregnancy
  • Celiac disease

Sites / Locations

  • Department of Clinical Medicine and Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Low fat- Low glycemic index

MUFA- Low glycemic index

SAFA- Low glycemic index

Low fat- High glycemic index

MUFA- High glycemic index

SAFA- High glycemic index

Arm Description

Participants consumed a meal with low glycemic index and poor in fat

Participants consumed a meal with low glycemic index and rich in MUFA

Participants consumed a meal with low glycemic index and rich in SAFA

Participants consumed a meal with high glycemic index and low in fat

Participants consumed a meal with high glycemic index and rich in MUFA

Participants consumed a meal with high glycemic index and rich in SAFA

Outcomes

Primary Outcome Measures

postprandial incremental glucose AUC

Secondary Outcome Measures

Full Information

First Posted
January 1, 2015
Last Updated
January 2, 2015
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT02330939
Brief Title
Fats And Carbohydrates Quality on Postprandial glycemIc Response in Type 1 Diabetes
Acronym
FACILE
Official Title
Impact of Fats And Carbohydrates Quality on Postprandial glycemIc Response in People With Type 1 diabEtes on Insulin Pump (FACILE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Postprandial glycemia, Momounsaturated fatty acids, Saturated fatty acids, Glycemic index, Glycemic load, Sensor augmented pump system

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low fat- Low glycemic index
Arm Type
Active Comparator
Arm Description
Participants consumed a meal with low glycemic index and poor in fat
Arm Title
MUFA- Low glycemic index
Arm Type
Experimental
Arm Description
Participants consumed a meal with low glycemic index and rich in MUFA
Arm Title
SAFA- Low glycemic index
Arm Type
Experimental
Arm Description
Participants consumed a meal with low glycemic index and rich in SAFA
Arm Title
Low fat- High glycemic index
Arm Type
Active Comparator
Arm Description
Participants consumed a meal with high glycemic index and low in fat
Arm Title
MUFA- High glycemic index
Arm Type
Experimental
Arm Description
Participants consumed a meal with high glycemic index and rich in MUFA
Arm Title
SAFA- High glycemic index
Arm Type
Experimental
Arm Description
Participants consumed a meal with high glycemic index and rich in SAFA
Intervention Type
Other
Intervention Name(s)
Low fat- Low glycemic index meal
Intervention Type
Other
Intervention Name(s)
MUFA- Low glycemic index meal
Intervention Type
Other
Intervention Name(s)
SAFA- Low glycemic index meal
Intervention Type
Other
Intervention Name(s)
Low fat- High glycemic index meal
Intervention Type
Other
Intervention Name(s)
MUFA- High glycemic index meal
Intervention Type
Other
Intervention Name(s)
SAFA- High glycemic index meal
Primary Outcome Measure Information:
Title
postprandial incremental glucose AUC
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Type 1 diabetes treated by insulin pump Exclusion Criteria: Pregnancy Celiac disease
Facility Information:
Facility Name
Department of Clinical Medicine and Surgery
City
Naples
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
30567626
Citation
Bozzetto L, Alderisio A, Clemente G, Giorgini M, Barone F, Griffo E, Costabile G, Vetrani C, Cipriano P, Giacco A, Riccardi G, Rivellese AA, Annuzzi G. Gastrointestinal effects of extra-virgin olive oil associated with lower postprandial glycemia in type 1 diabetes. Clin Nutr. 2019 Dec;38(6):2645-2651. doi: 10.1016/j.clnu.2018.11.015. Epub 2018 Dec 4.
Results Reference
derived
PubMed Identifier
26861923
Citation
Bozzetto L, Alderisio A, Giorgini M, Barone F, Giacco A, Riccardi G, Rivellese AA, Annuzzi G. Extra-Virgin Olive Oil Reduces Glycemic Response to a High-Glycemic Index Meal in Patients With Type 1 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2016 Apr;39(4):518-24. doi: 10.2337/dc15-2189. Epub 2016 Feb 9.
Results Reference
derived

Learn more about this trial

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

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