Dietary Fat and Endothelial Function in Type 1 Diabetes

NCT ID: NCT04812782

Last Updated: 2021-03-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2019-10-16

Brief Summary

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The purpose of this study is to evaluate the effects of the add-on of extra vergin olive oil or butter to a high glycemic index meal on endothelial function in subjects with type 1 Diabetes and healthy subjects.

Detailed Description

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Impaired endothelial function is an early manifestation of atherosclerosis and predictor of incident cardiovascular events. Diabetes affects arterial vasodilation by reducing the bioavailability of NO and more in general affecting the balance between the atheroprotective and atherothrombotic properties of the endothelium. A consistent number of studies has so far documented that Mediterranean-style diet associates with reduced risk of cardiovascular diseases and diabetes. Intake of extra virgin olive oil (EVOO), that is a common but not necessary ingredient of the Mediterranean diet, seems to further enhance the beneficial cardiovascular effect and reduce the incidence of diabetes. We have designed the present study to test whether EVOO supplementation acutely influences endothelial function in T1DM. EVOO supplementation wil be compared to butter supplementation in the context of a high glycemic index (GI) meal that is known to increase PP glycemic burden.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Cross-over, interventional, controlled study.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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EVOO-Butter

All patients and control subjects who met inclusion and exclusion criteria, and signed the Informed Consent, were scheduled for the two study visits, one week apart, during which each participant received two types of high GI meal: the first enriched with EVOO and the second with butter.

Group Type EXPERIMENTAL

EVOO supplementation

Intervention Type DIETARY_SUPPLEMENT

We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with EVOO

Butter supplementation

Intervention Type DIETARY_SUPPLEMENT

We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with butter

Butter-EVOO

All patients and control subjects who met inclusion and exclusion criteria, and signed the Informed Consent, were scheduled for the two study visits, one week apart, during which each participant received two types of high GI meal: the first enriched with Butter and the second with EVOO

Group Type EXPERIMENTAL

EVOO supplementation

Intervention Type DIETARY_SUPPLEMENT

We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with EVOO

Butter supplementation

Intervention Type DIETARY_SUPPLEMENT

We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with butter

Interventions

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EVOO supplementation

We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with EVOO

Intervention Type DIETARY_SUPPLEMENT

Butter supplementation

We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with butter

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years,
* diagnosis of type 1 diabetes since at least 1 year,
* HbA1c \<8.5% (69 mmol/mol),
* stable insulin therapy for at least 3 months before the enrolment into the study

Exclusion Criteria

* pregnancy, celiac disease, history of cardiovascular diseases, hypertension, hyperlipidemia, retinopathy, nephropathy, neuropathy, and ongoing treatment with vasoactive drugs.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Magna Graecia

OTHER

Sponsor Role lead

Responsible Party

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Concetta Irace

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Magna Graecia

Catanzaro, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Dietary Fat in Type 1 Diabetes

Identifier Type: -

Identifier Source: org_study_id

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