Reducing Cardiovascular Risks: The Role of Alcohol Use
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Change in in-laboratory central and peripheral blood pressure
研究概览
简要总结
The purpose of this study is to learn whether avoiding alcohol can improve heart and blood vessel health in adults who regularly drink alcohol and have high blood pressure. High blood pressure is a major risk factor for cardiovascular disease (CVD), including heart attack and stroke.
In this randomized, controlled trial, men and women aged 26 to 49 years who regularly consume alcohol and have high blood pressure will be assigned by chance to either stop drinking alcohol or continue their usual drinking habits for 8 weeks. Researchers will compare changes in blood pressure and other cardiovascular disease risk factors between the two groups.
The information gained from this study may help researchers and health care providers better understand the effects of alcohol consumption on cardiovascular health and whether alcohol abstinence can reduce heart disease risk, especially in adults with high blood pressure.
详细描述
The overarching objective is to determine the effect of alcohol abstinence on cardiovascular disease risks in individuals who consume alcoholic beverages over the recommended limits. After baseline assessment, participants will be randomly assigned to receive one of the interventions: either continue their usual drinking habits or to abstain from alcohol drinking. Before and after the 8-week intervention, blood pressure and sub-clinical cardiovascular disease risk factors (including arterial stiffness, endothelial function, and sympathetic nerve activity) will be measured. A longitudinal assessment of objective sleep will be performed throughout the study participation. Participants will be asked to maintain their diet and physical activity throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 26 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 26 to 49 years
- •At-risk drinkers who drink over the recommended limits, defined as those with PEth (≥20 ng/dL) or those with a U.S. Alcohol Use Disorders Identification Test (USAUDIT) score ≥8/7 for men/women
- •Elevated blood pressure or hypertension (systolic blood pressure: 120-160 mmHg and/or diastolic blood pressure 80-100 mmHg)
排除标准
- •History of CVD or cardiovascular events (e.g., stroke, myocardial infarction)
- •The presence of myocardial ischemia or arrhythmias with abnormal ECG and blood pressure during a clinically-supervised maximal graded exercise test
- •Hypertension (systolic >160 mmHg and diastolic >100 mmHg)
- •On more than one anti-hypertensive medication, or on other physician-prescribed medications (but not including oral contraceptives)
- •Major psychiatric disorders, including autism, ADHD, bipolar disorder, major depression, schizophrenia, and substance use disorders
- •Alcohol use disorder, PEth ≥400 ng/mL, or USAUDIT score ≥ 25
- •Current or history of any tobacco use in the past 6 months (including, but not limited to, cigarettes, e-cigarettes, hookah, Nicorette, snus and chewing tobacco)
- •Current or history of illicit and recreational drug use (more than 3 times in the past month and more than 15 times in their lifetime)
- •Diabetes type 1 & type 2 with fasting blood glucose ≥126 mg/dL
- •Presence of renal disease with a creatinine > 1.5 mg/dL
- •Presence of liver disease with liver enzymes > 3x the upper limits of normal
- •Anemia with a hemoglobin < 8 g/dL
- •Diagnosis of chronic inflammatory disease such as, but not limited to, cancer
- •Diagnosis of chronic autoimmune diseases such as, but not limited to lupus, multiple sclerosis, rheumatoid arthritis
- •Diagnosis of chronic obstructive pulmonary disease, pulmonary fibrosis, pneumonia, lung cancer, and cystic fibrosis
- •Diagnosis of neurological diseases, including seizure disorders, Alzheimer's disease, Parkinson's disease, multiple sclerosis, stroke, traumatic brain injury, and peripheral neuropathies
- •Body mass index <18.5 or ≥40 kg/m2
- •Unstable body weight (>5% change during the past 6 months)
- •Obstructive sleep apnea
- •Night-shift work
- •Women who are pregnant (or intend to become pregnant while participating in study), breastfeeding, or postmenopausal
结局指标
主要结局
Change in in-laboratory central and peripheral blood pressure
时间窗: Baseline and after the 8-week intervention
In-laboratory central blood pressure will be measured after a 10-min rest in supine position, while in-laboratory peripheral blood pressure will be measured after a 10-min rest in seated position.
Change in nighttime central and peripheral blood pressure
时间窗: Baseline and after the 8-week intervention
Blood pressure during nighttime (or sleep) will be measured by using a portable blood pressure monitor.
次要结局
- Change in arterial stiffness(Baseline and after the 8-week intervention)
- Change in endothelial function as measured by brachial artery flow-mediated dilation (FMD)(Baseline and after the 8-week intervention)
- Change in muscle sympathetic nerve activity (MSNA)(Baseline and after the 8-week intervention)