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临床试验/NCT03757845
NCT03757845终止不适用

A Comparison of Mediterranean Diet vs. Standard Diet in CABG Patients on Cardiac Cell Signaling And Composition of Lipid Content

MaineHealth2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
MaineHealth
入组人数
1
试验地点
2
主要终点
Quantity of specific lipids in atrial tissue

研究概览

简要总结

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.

详细描述

Study Design: The study is a prospective, un-blinded, randomized interventional clinical trial comparing ModMeD to standard cardiac diet in 48 (24 per arm) inpatients with type II DM scheduled for CABG at MMC and who are scheduled to stay in the hospital for four (4) or more days prior to surgery.

While it is not feasible to blind the subjects or clinicians, laboratory investigators processing specimens and analyzing biological responses to the intervention will be blinded. Specifically, tissue samples will be de-identified and coded before transferring to the laboratory.

Primary Objective: To determine if a Mediterranean diet causes rapid changes in lipid content (as determined by mass spectrometry) and in cardiac cell activity (as determined by ERBB2 expression level) among patients with TIIDM undergoing CABG surgery at MMC.

Study Arms:

  1. Standard Cardiac DM Diet (SCaDMD) during the inpatient stay (before and after CABG surgery)
  2. Mediterranean Diet (MedD) during the inpatient stay (before and after CABG surgery)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Expected survival less than one year
  • Non-English speaker

结局指标

主要结局

Quantity of specific lipids in atrial tissue

时间窗: at time of surgery, an average of 4 days

Liquid chromatographic/mass spectroscopic lipidomic analysis of atrial tissue

Quantity of ERBB receptors expressed on atrial endothelial cells

时间窗: at time of surgery, an average of 4 days

Expression of ERBB receptors in atrial endothelial cells by flow cytometry

次要结局

  • Quantity of specific lipids in plasma(through study completion, an average of 9 days)

研究者

发起方
MaineHealth
申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas B. Sawyer

Chief of Cardiovascular Services

MaineHealth

研究点 (2)

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