Effects of Mediterranean Diet Intervention in Diabetic Heart Disease
Public ClinicalTrials.gov record NCT03757845. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Comparison of Mediterranean Diet vs. Standard Diet in CABG Patients on Cardiac Cell Signaling And Composition of Lipid Content
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Diabetes Mellitus (DM) is a global epidemic associated with inflammation, aggressive atherosclerosis and increased risk for, and severity of, coronary artery disease. Strategies to improve glycemic control with insulin and/or oral hypoglycemic agents have not impacted cardiovascular morbidity and mortality in type II DM patients with known heart disease. The Investigators have found that the typical "Western" diet, which is high in saturated fats, such as the lipid palmitate, but low in unsaturated fats, such as the lipid oleate, results in changes to cell membrane lipid content and disruptions to membrane functional domains -called caveolae- that are associated with insulin resistance and metabolic dysfunction. In mice, the investigators found that palmitate induces both systolic and diastolic contractile dysfunction. They have demonstrated, in cell cultures, that oleate prevents palmitate-induced cell dysfunction. This may explain how a diet rich in unsaturated fats and plant-derived flavonoids, such as the "Mediterranean" diet, can counter the adverse cardiovascular effects of DM. This study builds in these prior findings and its central hypothesis is that, in DM, a Mediterranean diet can induce rapid changes in cardiac cell membrane lipid composition and signaling. This is a randomized dietary intervention in DM subjects scheduled for coronary artery bypass grafting (CABG) surgery, to examine the effects of a short-term modified Mediterranean diet (ModMeD), compared to the standard cardiac DM diet (SCaDMD), on receptor tyrosine kinase signaling, serum and cellular lipid content, and membrane/caveolae function.
Study identification
- NCT ID
- NCT03757845
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1 participant
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 14, 2018
- Primary completion
- Mar 23, 2023
- Completion
- Mar 23, 2023
- Last update posted
- Mar 27, 2023
2018 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Maine Medical Center | Portland | Maine | 04102 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03757845, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 27, 2023 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03757845 live on ClinicalTrials.gov.