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NCT04025281 · ClinicalTrials.gov registry record · NA
Post-prandial Effects of Extra Virgin Olive Oil on Endothelial Function in Adults at Risk for Type 2 Diabetes
A NA study of Type 2 Diabetes, sponsored by Griffin Hospital.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04025281: Completed NA study of Type 2 Diabetes, sponsored by Griffin Hospital.
NCT04025281 is a NA study of Type 2 Diabetes that has completed, run by Griffin Hospital. The registered enrollment target is 20 participants, below the 3,924-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04025281, a NA study of Type 2 Diabetes, has completed, sponsored by Griffin Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose: The number of cases of adults with Type 2 diabetes has quadrupled since 1980. This increase in the number of cases of diabetes is attributed to changes in dietary patterns, which include an increase in the consumption of obesogenic foods such as sugary foods and beverages. Patients with diabetes or at risk for diabetes are more likely to develop a cardiovascular event. Though glycemic control remains the basis of diabetes care, the co-management of atherosclerosis, hypertension and cardiovascular risk reduction, and prevention of long-term consequences are also important predictable measures to improve survival. The progression from prediabetes to Type 2 diabetes and complications of diabetes could be prevented. Lifestyle interventions (i.e., nutrition and physical activity) are the cornerstone for the primary prevention of Type 2 diabetes. Healthful eating can also improve cardio-metabolic risk factors associated with those at risk for or Type 2 diabetes. Foods that are low in fat and calories and high in fiber, with a focus on fruit, vegetables, whole grains, and the inclusion of healthful oils in their diets are typically recommended to prevent the progression from prediabetes to diabetes and complications of diabetes. Diets rich in mono- and polyunsaturated fatty acids have been shown to improve cardio-metabolic health in those at risk for or with Type 2 diabetes patients. However, the effect of olive oils on endothelial function (a surrogate marker of cardiovascular risk) in adults at risk for Type 2 diabetes is controversial. Refined olive oils lack important antioxidants and anti-inflammatory properties. Extra virgin olive oils have relatively higher levels of some minor phenolic compounds, and more naturally-occurring minerals and vitamins found in olives, that are essential to improve cardio-metabolic risk factors in those at risk for or with Type 2 diabetes. We propose a prospective, randomized, controlled crossover study to assess the post-prand
Primary Outcome
Endothelial function will be measured as Flow-mediated dilatation (FMD), that is the percent change in brachial artery diameter from pre-cuff inflation to 60-seconds post-cuff release. In addition to brachial diameter at 60 seconds post-cuff release, flow after cuff deflation within the first 15 seconds will be used as an indicator of stimulus strength, hyperemic flow being the stimulus for endothelial reactivity. To account for potential variability in stimulus strength, a secondary analysis wi
Conditions Studied
Interventions
- OTHER Extra Virgin Olive Oil
- OTHER Refined Olive Oil
Study Locations (1)
Connecticut
- Yale-Griffin Prevention Research Center - Derby
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-07-09 |
| Est. Completion | 2019-08-22 |
| Phase | NA |
What the finished NCT04025281 record still lists
NCT04025281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 3,924-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Extra Virgin Olive Oil is the first listed.
NCT04025281 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04025281 about?
NCT04025281 is a clinical study titled "Post-prandial Effects of Extra Virgin Olive Oil on Endothelial Function in Adults at Risk for Type 2 Diabetes". Purpose: The number of cases of adults with Type 2 diabetes has quadrupled since 1980. This increase in the number of cases of diabetes is attributed to changes in dietary patterns, which include an increase in the consumption of obesogenic foods such as sugary foods and beverages. Patients with di...
What is the current status of trial NCT04025281?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2019-07-09. Estimated completion is 2019-08-22.
What conditions does trial NCT04025281 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT04025281?
The interventions under investigation include: Extra Virgin Olive Oil (OTHER), Refined Olive Oil (OTHER).
Who is sponsoring clinical trial NCT04025281?
This trial is sponsored by Griffin Hospital, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04025281 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04025281's enrollment target sits among peer trials
20 290th of 327 higher than 23 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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