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

Type 1 Diabetes Clinical Trial

— FACILE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02330939
• Other study ID #: 980/14
• Status: Active, not recruiting
• Phase: N/A
• First received: January 1, 2015
• Last updated: January 2, 2015
• Start date: June 2014

Study information

• Verified date: January 2015
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

-Type 1 diabetes treated by insulin pump

Exclusion Criteria:

• Pregnancy

• Celiac disease

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• 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

Locations

Country	Name	City	State
Italy	Department of Clinical Medicine and Surgery	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postprandial incremental glucose AUC		6 hours	No