Exercise and Inflammation in the Elderly (IRIS)
2018年3月29日 更新者：VA Office of Research and Development
Exercise, Inflammation and Pro-thrombotic Modulators in the Elderly
Persistent low-grade inflammation and impaired fibrinolysis, are independent predictors of several chronic diseases highly prevalent in the older Veteran population including cardiovascular disease (CVD), stroke, and diabetes.
Inflammation is likely to be a causative underlying mechanism of insulin resistance.
Lifestyle changes such as weight loss and physical activity are advocated for the treatment of these chronic diseases and endpoints, and data are emerging which suggest that these treatments may be beneficial, in part, due to their anti-inflammatory effects.
Identification of effective therapies that reduce chronic inflammation for Veterans is important given the widespread adverse health effects of a chronically elevated inflammatory state.
研究概览
详细说明
This study will compare the effects of 6 month trial of aerobic exercise (AEX) vs. weight loss (WL) in older individuals on:
- adipokine secretion and expression (tumor necrosis factor alpha, adiponectin);
- adipose tissue and skeletal muscle inflammatory proximal receptor expression (adiponectin and tumor necrosis factor alpha expression) and signaling pathways; and
- whether the changes in signal transduction are associated with changes in peripheral whole body insulin sensitivity by a hyperinsulinemic-euglycemic clamp.
The prevention and treatment of insulin resistance, the metabolic syndrome, and their CVD complications through exercise and weight loss could improve Veterans' health and reduce health care costs. Knowledge of their effectiveness has important implications for the cardiovascular health of Veterans given the widespread adverse health effects of chronic inflammation on vascular biology, skeletal muscle function and insulin action.
研究类型
介入性
注册 (实际的)
119
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Maryland
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Baltimore、Maryland、美国、21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
45年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male and Female
- 45-80 yrs of age
- Non-smoking for one year
- Body mass index greater than 20 kg/m2 and less than 50 kg/m2
- Menopause over 1 year
Exclusion Criteria:
- Symptomatic heart disease, coronary artery disease, congestive heart failure, or uncontrolled hypertension (blood pressure over 180/100 mm Hg) unless medically stabilized
- Currently being treated for active cancer
- Type 1 diabetes; Insulin or oral agent treatment for diabetes, poorly controlled diabetes fasting blood glucose over 160 mg/dl
- Allergic to lidocaine
- Untreated dyslipidemia with National Cholesterol Adult Treatment Panel III 10 year cardiac risk score greater than 10%, or receiving triglyceride lowering meds
- Other systemic disorders that are not medically treated and stable
- Taking beta-blockers, oral steroids, warfarin or any other medications interfering with fat/muscle metabolism that may not be safely discontinued temporarily for specific procedures (ie for 72 hours prior)
- Abnormal response to exercise test (ST segment depression greater than 2mm, chest pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising BP above 240/120mm Hg, or other contraindications to exercise) *requires follow up treatment w/ primary MD for continued participation in study
- Abnormal liver function
- Abnormal renal function
- Chronic pulmonary disease
- Anemia hematocrit below 35 mg/dl, platelets below 100,000/cm3
- Mini-mental state exam below 24, dementia or unstable clinical depression by exam
- Aerobically trained with maximal oxygen consumption greater than 2 standard deviations above age-adjusted mean
- Exercise group only: History of cerebrovascular disease (by medical history) with symptoms limiting the ability to exercise
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm 1
6 months of aerobic exercise training
|
6 months of aerobic exercise training
|
|
实验性的：Arm 2
6 months of weight loss
|
6 months of weight loss
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Insulin Sensitivity
大体时间：Baseline and 6 month
|
Insulin resistance is defined as a reduction in glucose utilization rate elicited by a given insulin concentration.
Glucose utilization is measured during a three hour hyperinsulinemic-euglycemic clamp and is presented as a measure of insulin sensitivity.
This is one of the most sophisticated methods to measure insulin sensitivity.
|
Baseline and 6 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body Weight
大体时间：Baseline and 6 month
|
Baseline and 6 month
|
|
|
Fitness
大体时间：Baseline and 6 month
|
Maximal oxygen consumption (VO2max) on a treadmill
|
Baseline and 6 month
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Alice S Ryan, PhD、Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2007年4月1日
初级完成 (实际的)
2012年11月29日
研究完成 (实际的)
2012年11月29日
研究注册日期
首次提交
2008年9月12日
首先提交符合 QC 标准的
2008年9月12日
首次发布 (估计)
2008年9月16日
研究记录更新
最后更新发布 (实际的)
2018年6月26日
上次提交的符合 QC 标准的更新
2018年3月29日
最后验证
2018年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Aerobic Exercise Training的临床试验
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Karolinska InstitutetMinistry of Health and Social Affairs, Sweden完全的
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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Mental Health Services in the Capital Region, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention Research; Center for Clinical Intervention...完全的