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

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ClinicalTrials.gov Identifier: NCT02330939
Recruitment Status : Unknown
Verified January 2015 by rivellese angela, Federico II University.
Recruitment status was:  Active, not recruiting
First Posted : January 5, 2015
Last Update Posted : January 5, 2015
Sponsor:
Information provided by (Responsible Party):
rivellese angela, Federico II University

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of Fats And Carbohydrates Quality on Postprandial glycemIc Response in People With Type 1 diabEtes on Insulin Pump (FACILE Study)
Study Start Date : June 2014
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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



Primary Outcome Measures :
  1. postprandial incremental glucose AUC [ Time Frame: 6 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Type 1 diabetes treated by insulin pump

Exclusion Criteria:

  • Pregnancy
  • Celiac disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330939


Locations
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Italy
Department of Clinical Medicine and Surgery
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: rivellese angela, professor, Federico II University
ClinicalTrials.gov Identifier: NCT02330939    
Other Study ID Numbers: 980/14
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: January 2015
Keywords provided by rivellese angela, Federico II University:
Postprandial glycemia
Momounsaturated fatty acids
Saturated fatty acids
Glycemic index
Glycemic load
Sensor augmented pump system
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases