Dietary Fat and Endothelial Function in Type 1 Diabetes

University Magna Graecia

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Dietary Supplement: Butter supplementation; Dietary Supplement: EVOO supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT04812782

Dietary Fat in Type 1 Diabetes

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

EVOO-Butter

Experimental group

Description:

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.

Treatment:

Dietary Supplement: EVOO supplementation

Dietary Supplement: Butter supplementation

Butter-EVOO

Experimental group

Description:

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

Treatment:

Dietary Supplement: EVOO supplementation

Dietary Supplement: Butter supplementation