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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 is a NA study that was terminated before completion, run by MaineHealth. The registered enrollment target is 1 participants.

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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.

Interventions

  • OTHER Mediterranean Diet

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2018-12-15
Est. Completion 2023-03-24
Phase NA

Sponsor

MaineHealth

26 total trials

What the Registry Record Tells You About NCT03757845

The ClinicalTrials.gov registry entry for NCT03757845 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MaineHealth, which has 26 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Mediterranean Diet is the first listed.

NCT03757845 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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