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NCT03757845 · ClinicalTrials.gov registry record · NA
Effects of Mediterranean Diet Intervention in Diabetic Heart Disease
A NA study, sponsored by MaineHealth.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT03757845: Clinical Trial NA study, sponsored by MaineHealth.
NCT03757845 is a NA study that was terminated before completion, run by MaineHealth. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03757845, a NA study, was terminated before completion, sponsored by MaineHealth.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Liquid chromatographic/mass spectroscopic lipidomic analysis of atrial tissue
Interventions
- OTHER Mediterranean Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-12-15 |
| Est. Completion | 2023-03-24 |
| Phase | NA |
Why NCT03757845 stopped before completion
NCT03757845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Mediterranean Diet is the first listed.
NCT03757845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03757845 about?
NCT03757845 is a clinical study titled "Effects of Mediterranean Diet Intervention in Diabetic Heart Disease". 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 mo...
What is the current status of trial NCT03757845?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2018-12-15. Estimated completion is 2023-03-24.
What interventions are being tested in trial NCT03757845?
The interventions under investigation include: Mediterranean Diet (OTHER).
Who is sponsoring clinical trial NCT03757845?
This trial is sponsored by MaineHealth, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03757845's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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