Dietary Fat and Endothelial Function in Type 1 Diabetes

University Magna Graecia16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

EVOO supplementationDIETARY_SUPPLEMENT

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

Butter supplementationDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University Magna Graecia

Catanzaro, Italy

Outcomes

Primary Outcomes

Change of Endothelial function from pre meal to post meal period

Flow mediated dilation technique by ultrasound

Time frame: before meal, 1 hour, 3 hour, 5 hour after meal

Secondary Outcomes

Serum glucose

glucose-hexokinase method

Time frame: before meal, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour after meal

Gastric emptying rate

Ultrasound antrum measurement

Time frame: before meal, 15, 90, 120, 180, 240, 300 minutes after meal

Data from ClinicalTrials.gov

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