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Dietary Fat and Endothelial Function in Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EVOO supplementation
Butter supplementation
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring Endothelial function, FMD, gastric emptying, post prandial glycemia, dietary fat, EVOO, butter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • University Magna Graecia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

EVOO-Butter

Butter-EVOO

Arm 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.

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

Outcomes

Primary Outcome Measures

Change of Endothelial function from pre meal to post meal period
Flow mediated dilation technique by ultrasound

Secondary Outcome Measures

Serum glucose
glucose-hexokinase method
Gastric emptying rate
Ultrasound antrum measurement

Full Information

First Posted
March 12, 2021
Last Updated
March 20, 2021
Sponsor
University Magna Graecia
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1. Study Identification

Unique Protocol Identification Number
NCT04812782
Brief Title
Dietary Fat and Endothelial Function in Type 1 Diabetes
Official Title
Influence Of Extra Virgin Olive Oil and Butter on Endothelial Function in Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
October 16, 2019 (Actual)
Study Completion Date
October 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Magna Graecia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Endothelial function, FMD, gastric emptying, post prandial glycemia, dietary fat, EVOO, butter

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cross-over, interventional, controlled study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVOO-Butter
Arm Type
Experimental
Arm 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.
Arm Title
Butter-EVOO
Arm Type
Experimental
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
EVOO supplementation
Intervention Description
We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with EVOO
Intervention Type
Dietary Supplement
Intervention Name(s)
Butter supplementation
Intervention Description
We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with butter
Primary Outcome Measure Information:
Title
Change of Endothelial function from pre meal to post meal period
Description
Flow mediated dilation technique by ultrasound
Time Frame
before meal, 1 hour, 3 hour, 5 hour after meal
Secondary Outcome Measure Information:
Title
Serum glucose
Description
glucose-hexokinase method
Time Frame
before meal, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour after meal
Title
Gastric emptying rate
Description
Ultrasound antrum measurement
Time Frame
before meal, 15, 90, 120, 180, 240, 300 minutes after meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University Magna Graecia
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy

12. IPD Sharing Statement

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Dietary Fat and Endothelial Function in Type 1 Diabetes

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