Fats And Carbohydrates Quality on Postprandial glycemIc Response in Type 1 Diabetes
FACILE
Impact of Fats And Carbohydrates Quality on Postprandial glycemIc Response in People With Type 1 diabEtes on Insulin Pump (FACILE Study)
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 1, 2015
CompletedFirst Posted
Study publicly available on registry
January 5, 2015
CompletedJanuary 5, 2015
January 1, 2015
6 months
January 1, 2015
January 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postprandial incremental glucose AUC
6 hours
Study Arms (6)
Low fat- Low glycemic index
ACTIVE COMPARATORParticipants consumed a meal with low glycemic index and poor in fat
MUFA- Low glycemic index
EXPERIMENTALParticipants consumed a meal with low glycemic index and rich in MUFA
SAFA- Low glycemic index
EXPERIMENTALParticipants consumed a meal with low glycemic index and rich in SAFA
Low fat- High glycemic index
ACTIVE COMPARATORParticipants consumed a meal with high glycemic index and low in fat
MUFA- High glycemic index
EXPERIMENTALParticipants consumed a meal with high glycemic index and rich in MUFA
SAFA- High glycemic index
EXPERIMENTALParticipants consumed a meal with high glycemic index and rich in SAFA
Interventions
Eligibility Criteria
You may qualify if:
- Type 1 diabetes treated by insulin pump
You may not qualify if:
- Pregnancy
- Celiac disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Clinical Medicine and Surgery
Naples, 80131, Italy
Related Publications (2)
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.
PMID: 30567626DERIVEDBozzetto 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.
PMID: 26861923DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
January 1, 2015
First Posted
January 5, 2015
Study Start
June 1, 2014
Primary Completion
December 1, 2014
Last Updated
January 5, 2015
Record last verified: 2015-01