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Effects of Mediterranean Diet Intervention in Diabetic Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03757845
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : January 11, 2022
Information provided by (Responsible Party):
Douglas B. Sawyer, MaineHealth

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Complications Cardiovascular Diseases Other: Mediterranean Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized trial of dietary intervention
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Comparison of Mediterranean Diet vs. Standard Diet in CABG Patients on Cardiac Cell Signaling And Composition of Lipid Content
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2024

Arm Intervention/treatment
No Intervention: Control diet
Experimental: Mediterranean diet Other: Mediterranean Diet
subjects will be asked to eat from a sub-menu items compliant with Mediterranean Diet

Primary Outcome Measures :
  1. Quantity of specific lipids in atrial tissue [ Time Frame: at time of surgery, an average of 4 days ]
    Liquid chromatographic/mass spectroscopic lipidomic analysis of atrial tissue

  2. Quantity of ERBB receptors expressed on atrial endothelial cells [ Time Frame: at time of surgery, an average of 4 days ]
    Expression of ERBB receptors in atrial endothelial cells by flow cytometry

Secondary Outcome Measures :
  1. Quantity of specific lipids in plasma [ Time Frame: through study completion, an average of 9 days ]
    Liquid chromatographic/mass spectroscopic lipidomic analysis of plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Over 18 years of age
  2. A diagnosis of TIIDM (defined as current treatment with insulin or oral hypoglycemic medication or fasting glucose >126 mg/dl)
  3. Hemoglobin A1c level greater than 7.5%
  4. Planned coronary artery bypass grafting (CABG) (primary only)
  5. Planned pre-surgical hospital stay
  6. Willingness to adhere to Mediterranean diet while an inpatient at MMC

Exclusion Criteria:

  1. Less than 18 years of age
  2. Unwillingness or inability to provide informed consent
  3. Planned surgery within 48 hours
  4. Active myocarditis
  5. Hypertrophic cardiomyopathy
  6. Constrictive pericarditis
  7. Prior or current pericardial disease requiring surgical intervention
  8. Significant renal impairment (Cr > 2.5 mg/dL)
  9. Food allergies towards tree nuts or other food items included on the Mediterranean menu
  10. Pregnancy
  11. Expected survival less than one year
  12. Non-English speaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03757845

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Contact: Douglas Sawyer, MD, PhD 207-662-2414
Contact: Ivette Emery, PhD 207-396-7623

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United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Douglas Sawyer, MD         
Principal Investigator: Douglas Sawyer, MD         
Sponsors and Collaborators
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Principal Investigator: Douglas B Sawyer, MD, PhD MaineHealth
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Responsible Party: Douglas B. Sawyer, Chief of Cardiovascular Services, MaineHealth Identifier: NCT03757845    
Other Study ID Numbers: 1242439-2
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases