Reduction of Cardiac Steatosis and Improvement of Diastolic Function by Modulating Metabolic Health in Obese Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change From Baseline at 1 Year in Myocardial Lipid Content
研究概览
简要总结
The purpose of this study is to determine whether 1 year of supervised exercise training in obese individuals at high risk for developing HF, incorporating high intensity interval training (HIIT) two to three times per week in conjunction with daily oral administration of omega-3 poly-unsaturated fatty acids will lead to reduction in visceral adiposity, regression of myocardial triglyceride levels and improvements in cardiac diastolic and vascular function.
详细描述
The global objective of this project is to test novel strategies to prevent obesity related abnormalities in diastolic function that may progress to heart failure with preserved ejection fraction (HFpEF). These include: a) identifying high risk individuals by using population derived imaging and blood biomarkers; and b) implementing novel exercise training and "nutri-ceutical" strategies in obese middle aged individuals with high amounts of visceral fat, an important risk factor in the development of heart failure and adverse cardiac remodeling.
Prior work has demonstrated that: a) high levels of myocardial triglyceride content are associated with a smaller and less distensible left ventricle with reduced tissue relaxation rates compared to those with low levels and b) low fitness and high body mass index were the strongest predictors of elevated myocardial content. The consequences of excess visceral adiposity (intra- and retro-peritoneal adipose tissue) on cardiac remodeling suggest individuals with high visceral fat content and low fitness are at particularly high risk for heart failure.
The primary objective of this project is therefore to identify high risk, sedentary, middle aged obese individuals with high visceral fat levels, and initiate an exercise program in conjunction with omega-3 fatty acid supplementation designed to reduce visceral adiposity and regress myocardial triglyceride accumulation. Findings from this aim would have enormous public health significance and establish a novel, practical exercise training program and "nutria-ceutical" strategy to reverse obesity related cardiovascular remodeling.
Hypothesis:
High aerobic exercise training in conjunction with daily omega-3 supplementation will reduce visceral myocardial triglyceride accumulation by reducing visceral adiposity. A reduction of myocardial fat will lead to improved LV structure and diastolic function by an approach that is not necessarily predicated on weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Subjects and investigative team (except for statistician) are blinded to omega-3 vs olive oil placebo. Subjects and investigators are aware of exercise modality. Outcomes assessors are blinded to all aspects of subject randomization.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ejection fraction >0.50
- •>2.0 kg visceral fat (intra- and retro-peritoneal adipose tissue)
- •either a high sensitivity troponin (>0.6pg/ml), or NTBNP (>40 ng/ml)
- •age range 40 -60
- •BMI range 30 - 50 kg/m2
排除标准
- •age < 40 or > 60
- •body mass index > 50, < 30 kg/m2
- •history of insulin dependent diabetes, heart failure, myocarditis, restrictive cardiomyopathy, permanent/persistent atrial fibrillation, severe chronic obstructive pulmonary disease, unstable coronary artery disease or recent (<12 month) acute coronary syndrome, cerebrovascular disease as evidenced by prior transient ischemic attack or stroke and active/recent tobacco use (quit < 5 years).
- •Female patients will be excluded if they are pregnant or plan to become pregnant (expected rare occurrence in the selected age range of 40 - 60).
- •Patients will be excluded if they are taking non-statin lipid lowering agents (fibrates, niacin, or fish oils)
- •Contra-indications to MRI
结局指标
主要结局
Change From Baseline at 1 Year in Myocardial Lipid Content
时间窗: Baseline, 1 year
Myocardial triglyceride (lipid) content will be measured using cardiac nuclear magnetic resonance spectroscopy. We quantified the total myocardial triglyceride (TG) resonance from water-suppressed spectra. Myocardial TG content relative to water (%) as well as relative amounts of myocardial TG was calculated from the available data.
次要结局
- Change From Baseline at 1 Year in Left Ventricular Mass(Baseline, 1 year)
- Change From Baseline at 1 Year in Markers of Arterial Stiffness(Baseline, 1 year)
- Change From Baseline at 1 Year in Peak Volume of Oxygen (VO2)(Baseline,1 year)
研究者
Satyam Sarma
ASSISTANT PROFESSOR
University of Texas Southwestern Medical Center