Dietary Fat and Endothelial Function in Type 1 Diabetes

Influence Of Extra Virgin Olive Oil and Butter on Endothelial Function in Type 1 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Dietary supplement: EVOO supplementation; Dietary supplement: Butter supplementation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • University Magna Graecia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: EVOO supplementation; We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with EVOO; Dietary supplement: Butter supplementation; We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with butter
Experimental: 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	Dietary supplement: EVOO supplementation; We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with EVOO; Dietary supplement: Butter supplementation; We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with butter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Endothelial function from pre meal to post meal period	Flow mediated dilation technique by ultrasound	before meal, 1 hour, 3 hour, 5 hour after meal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum glucose	glucose-hexokinase method	before meal, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour after meal
Gastric emptying rate	Ultrasound antrum measurement	before meal, 15, 90, 120, 180, 240, 300 minutes after meal

Collaborators and Investigators

• Sponsor: University Magna Graecia

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): October 16, 2019
• Study Completion (Actual): October 16, 2019

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 20, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 20, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: gastric emptying; Endothelial function; dietary fat; FMD; post prandial glycemia; EVOO; butter
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Dietary Fat in Type 1 Diabetes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No