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

Federico II University

Status: Unknown

Conditions: Type 1 Diabetes

Treatments: Other: SAFA- Low glycemic index meal; Other: SAFA- High glycemic index meal; Other: MUFA- High glycemic index meal; Other: Low fat- Low glycemic index meal; Other: MUFA- Low glycemic index meal; Other: Low fat- High glycemic index meal

Study type: Interventional

Funder types: Other

Identifiers

NCT02330939

980/14

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Type 1 diabetes treated by insulin pump

Exclusion criteria

• Pregnancy
• Celiac disease

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 6 patient groups

Low fat- Low glycemic index

Active Comparator group

Description:

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

Treatment:

Other: Low fat- Low glycemic index meal

MUFA- Low glycemic index

Experimental group

Description:

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

Treatment:

Other: MUFA- Low glycemic index meal

SAFA- Low glycemic index

Experimental group

Description:

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

Treatment:

Other: SAFA- Low glycemic index meal

Low fat- High glycemic index

Active Comparator group

Description:

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

Treatment:

Other: Low fat- High glycemic index meal

MUFA- High glycemic index

Experimental group

Description:

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

Treatment:

Other: MUFA- High glycemic index meal

SAFA- High glycemic index

Experimental group

Description:

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

Treatment:

Other: SAFA- High glycemic index meal