Effects of Mediterranean Diet Intervention in Diabetic Heart Disease

NCT03757845 | Terminated DMC

• 1 other identifier: 1242439-2
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Complications; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• Quantity of specific lipids in atrial tissue

  Liquid chromatographic/mass spectroscopic lipidomic analysis of atrial tissue

  at time of surgery, an average of 4 days

• Quantity of ERBB receptors expressed on atrial endothelial cells

  Expression of ERBB receptors in atrial endothelial cells by flow cytometry

  at time of surgery, an average of 4 days

Secondary Outcomes (1)

• Quantity of specific lipids in plasma

  through study completion, an average of 9 days

Study Arms (2)

Control diet

NO INTERVENTION

Mediterranean diet

EXPERIMENTAL

Other: Mediterranean Diet

Interventions

Mediterranean Diet OTHER

subjects will be asked to eat from a sub-menu items compliant with Mediterranean Diet

Mediterranean diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MaineHealth: lead

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

MeSH Terms

Conditions

Diabetes Complications; Cardiovascular Diseases

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Douglas B Sawyer, MD, PhD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Cardiovascular Services

Model Details: Randomized trial of dietary intervention

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 29, 2018
• Study Start: December 15, 2018
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)