Skip to main content
OpenTrials
Completed

NCT Number: NCT04812782

Dietary Fat and 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Magna Graecia

Catanzaro, 88100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EVOO supplementation

Dietary Supplement

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

Butter supplementation

Dietary Supplement

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

Primary outcomes

  1. Change of Endothelial function from pre meal to post meal period

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

    Flow mediated dilation technique by ultrasound

Secondary outcomes

  1. Serum glucose

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

    glucose-hexokinase method

  2. Gastric emptying rate

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

    Ultrasound antrum measurement

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 24, 2021
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.