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

NCT ID: NCT02330939

Last Updated: 2015-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Low fat- Low glycemic index

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

Group Type ACTIVE_COMPARATOR

Low fat- Low glycemic index meal

Intervention Type OTHER

MUFA- Low glycemic index

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

Group Type EXPERIMENTAL

MUFA- Low glycemic index meal

Intervention Type OTHER

SAFA- Low glycemic index

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

Group Type EXPERIMENTAL

SAFA- Low glycemic index meal

Intervention Type OTHER

Low fat- High glycemic index

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

Group Type ACTIVE_COMPARATOR

Low fat- High glycemic index meal

Intervention Type OTHER

MUFA- High glycemic index

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

Group Type EXPERIMENTAL

MUFA- High glycemic index meal

Intervention Type OTHER

SAFA- High glycemic index

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

Group Type EXPERIMENTAL

SAFA- High glycemic index meal

Intervention Type OTHER

Interventions

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Low fat- Low glycemic index meal

Intervention Type OTHER

MUFA- Low glycemic index meal

Intervention Type OTHER

SAFA- Low glycemic index meal

Intervention Type OTHER

Low fat- High glycemic index meal

Intervention Type OTHER

MUFA- High glycemic index meal

Intervention Type OTHER

SAFA- High glycemic index meal

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

-Type 1 diabetes treated by insulin pump

Exclusion Criteria

* Pregnancy
* Celiac disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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rivellese angela

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Clinical Medicine and Surgery

Naples, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 30567626 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26861923 (View on PubMed)

Other Identifiers

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980/14

Identifier Type: -

Identifier Source: org_study_id

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