Type 1 DiabetesNCT04812782
Dietary Fat and Endothelial Function in Type 1 Diabetes
A study testing EVOO supplementation and Butter supplementation in people with Type 1 Diabetes, run by University Magna Graecia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- EVOO supplementation and Butter supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 12 Feb 2018to 16 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy, celiac disease, history of cardiovascular diseases, hypertension, hyperlipidemia, retinopathy, nephropathy, neuropathy, and ongoing treatment with vasoactive drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- EVOO supplementation, Butter supplementation
- Keywords
- Endothelial function, FMD, gastric emptying, post prandial glycemia, dietary fat, EVOO, butter
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| EVOO-Butter | Experimental | 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. Receives: Dietary Supplement: EVOO supplementation; Dietary Supplement: Butter supplementation |
| Butter-EVOO | Experimental | 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 Receives: Dietary Supplement: EVOO supplementation; Dietary Supplement: Butter supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Endothelial function from pre meal to post meal period
Flow mediated dilation technique by ultrasound
Measured: before meal, 1 hour, 3 hour, 5 hour after meal
Secondary outcomes (2)
Serum glucose
glucose-hexokinase method
Measured: before meal, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour after meal
Gastric emptying rate
Ultrasound antrum measurement
Measured: before meal, 15, 90, 120, 180, 240, 300 minutes after meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start12 Feb 2018
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-over, interventional, controlled study.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Concetta Irace, University Magna Graecia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812782
- Sponsor's protocol ID
- Dietary Fat in Type 1 Diabetes
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence Of Extra Virgin Olive Oil and Butter on Endothelial Function in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04812782
- Acronym / sponsor ID
- Dietary Fat in Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Keywords
- Endothelial function, FMD, gastric emptying, post prandial glycemia, dietary fat, EVOO, butter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-over, interventional, controlled study.
| Arm | Type | Receives |
|---|---|---|
| EVOO-Butter | Experimental | Dietary Supplement: EVOO supplementation, Dietary Supplement: Butter supplementationAll 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. |
| Butter-EVOO | Experimental | Dietary Supplement: EVOO supplementation, Dietary Supplement: Butter supplementationAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- pregnancy, celiac disease, history of cardiovascular diseases, hypertension, hyperlipidemia, retinopathy, nephropathy, neuropathy, and ongoing treatment with vasoactive drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVOO supplementationWe will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with EVOO | Dietary supplement | Butter-EVOO, EVOO-Butter |
| Butter supplementationWe will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with butter | Dietary supplement | Butter-EVOO, EVOO-Butter |
Primary outcome
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
2 secondary outcomes
Serum glucose
Time frame: before meal, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour after meal
Gastric emptying rate
Time frame: before meal, 15, 90, 120, 180, 240, 300 minutes after meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVOO supplementation and Butter supplementation in people with Type 1 Diabetes, run by University Magna Graecia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Endothelial function from pre meal to post meal period (time frame: before meal, 1 hour, 3 hour, 5 hour after meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.