衰老在健康和疾病中的代谢和功能后果
Considerable heterogeneity in the aging population has been observed. The exceptional longevity of individuals reaching 100 years old, so-called centenarians may be an example of life-long healthy aging, or added years may be spent in poor health with decreased physical and cognitive functioning. Current knowledge of the aging experience and the trajectories of physical and cognitive decline across various age groups are not well-understood, yet crucial to prevent spending added years in disease. Hence, the study objective is to develop the metabolic profile associated with aging-related disorders measured as the incidence of impaired functional capacity, cognitive function, and/or well-being.
研究概览
详细说明
Our lab developed a pulse method combining multiple stable tracers to study multiple metabolic pathways in the same individual simultaneously. By measuring whole-body metabolism in a large group of older adults, we may be able to unravel age-related deterioration in protein turnover (synthesis and breakdown) that contributes to impaired functional capacity. Metabolic profiles could explain differences in pathways in the aging process with a special interest in the metabolism of amino acids as they have been associated with aging-related disorders. Studies on the effect of aging on metabolism might serve as potential therapeutic targets.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Laura Ruebush, PhD
- 电话号码：979-422-1789
- 邮箱：le.ruebush@ctral.org
研究联系人备份
- 姓名：Marielle Engelen, PhD
- 电话号码：979-422-1789
- 邮箱：mpkj.engelen@ctral.org
学习地点
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Texas
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College Station、Texas、美国、77845
- 招聘中
- Human Clinical Research Building
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接触：
- Laura Ruebush, PhD
- 邮箱：le.ruebush@ctral.org
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
We will screen 400 subjects (to complete n=320). This number includes screen failures and drop-outs. We expect some dropout between screening and enrollment. Subjects who drop out prior to the successful completion of the study will be replaced. Data will be used up to the point of withdrawal. Age range: 50 years or older, inclusive; Ethnicity: all races and ethnicities.
描述
Inclusion Criteria:
- Stable body-weight (± 5%) for the past 3 months
- Subject is judged to be in satisfactory health based on medical history, physical examination, and laboratory screening evaluations.
- Ability to walk, sit down and stand up independently or with walking mobility aids
- Ability to lie in a supine or elevated position for up to 3 hours
- Discharged within 30 days after a hospital admittance for >48-hours (recently hospitalized group only)
- Diagnosis of heart failure (stages 2-4 heart failure based on the New York Heart Association Functional Class; heart failure group only)
- Willingness and ability to comply with the protocol
Exclusion Criteria:
- Insulin dependent diabetes mellitus
- Established diagnosis of malignancy
- History of untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Presence of fever within the last 3 days
- Use of short course of oral corticosteroids within 4 weeks preceding study day
- Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- (Possible) pregnancy
- Already enrolled in another clinical trial and that clinical trial interferes with participating in this study
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Controls
Study subjects that are eligible based on inclusion/exclusion criteria Screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Study day(s): may include combinations of stable tracer infusions and with blood draws, cognitive and muscle performance testing |
Multiple stable-labeled tracers of amino acids, ketoacids, glycerol, short-chain fatty acids
其他名称：
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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 |
|---|---|---|
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Age-related changes in whole-body protein and amino acid metabolism
大体时间：2 hours
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Whole-body production rate measured after stable tracer administration |
2 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Age-related changes in whole-body glucose metabolism
大体时间：2 hours
|
Whole-body production rate measured after stable tracer administration |
2 hours
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Age-related changes in whole-body fat metabolism
大体时间：2 hours
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Whole-body production rate measured after stable tracer administration |
2 hours
|
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Age-related changes in depression as measured by the Hospital Anxiety and Depression Scale (HADS) and Geriatric Depression Scale (if applicable)
大体时间：baseline visit
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Self-reported depression measured by a validated questionnaire related to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms). A higher score indicates a worse outcome (greater self-reported depression symptoms). |
baseline visit
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Age-related changes in anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)
大体时间：baseline visit
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Anxiety measured by a validated questionnaire related to anxiety-related symptoms. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) related to anxiety. A higher score indicates a worse outcome (greater self-reported anxiety symptoms). |
baseline visit
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Age-related changes in mood as measured by the Profile of Mood State (POMS)
大体时间：baseline visit
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A psychological distress scale to measure the mood disturbance in 6 domains - fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment in the past week. Each item on the questionnaire is awarded a score from 0 ("not at all") to 4 ("extremely"), except "Relaxed" and "Efficient" scored 4 ("not at all") and 0 ("extremely"), based on the intensity of the assessed feeling in the past week. |
baseline visit
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Age-related changes in health status
大体时间：baseline visit
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Health status assessed by Health-Related Quality of Life Scale (HR-QoL) |
baseline visit
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Age-related changes in physical activity
大体时间：baseline visit
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Physical activity assessed by Physical Activity Scale for the Elderly (PASE) |
baseline visit
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Age-related changes in sleep quality
大体时间：baseline visit
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Sleep quality assessed by Pittsburgh Sleep Quality Index |
baseline visit
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Age-related changes in nutritional status
大体时间：baseline visit
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Nutritional status assessed by Mini-Nutritional Assessment |
baseline visit
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Age-related changes in attention and executive functions as measured by Trail Making Test (TMT)
大体时间：baseline visit
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In Part A, the examinee is instructed to connect a set of 25 circles with numbers as quickly as possible while maintaining accuracy. In Part B, the examinee is instructed to connect a set of 25 circles, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and mental flexibility. The total time in seconds was reported for each measure. |
baseline visit
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Age-related changes in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
大体时间：baseline visit
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MoCa assesses several cognitive domains and is used for the screening of mild cognitive impairment. Total scores range from 0-30 with lower scores indicating decreased functioning. |
baseline visit
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Age-related changes in exercise capacity
大体时间：baseline visit
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Functional exercise capacity assessed by 6-minute walk test |
baseline visit
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Age-related changes in physical weakness (frailty)
大体时间：baseline visit
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Physical weakness assessed by Short Physical Performance Battery |
baseline visit
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Age-related changes in skeletal muscle strength of the upper extremity
大体时间：baseline visit
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Skeletal muscle strength measured by handgrip test |
baseline visit
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Age-related changes in skeletal muscle strength of the lower extremity
大体时间：baseline visit
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Skeletal muscle strength measured by one-leg test |
baseline visit
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Age-related changes in respiratory muscle strength
大体时间：baseline visit
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Respiratory muscle strength measured by a hand-held mouth pressure device (Micro RPM) |
baseline visit
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Age-related changes in balance
大体时间：baseline visit
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Skeletal muscle strength measured by Berg Balance Scale and balance platform |
baseline visit
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Age-related changes in gut microbiota
大体时间：baseline visit
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The amount and types of microbiota assessed in collected stool sample |
baseline visit
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Age-related changes in gut function
大体时间：baseline visit
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Gut function assessed by Gastrointestinal Symptom Rating Scale, a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. A higher score indicates worse outcomes (more discomfort). |
baseline visit
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Age-related changes in hand dexterity
大体时间：baseline visit
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Hand dexterity assessed by the Nine-Hole Peg Test (9-HPT), a standardized, quantitative assessment in which the subject is asked to take pegs from a container, one by one, and place them into the holes on the board. Time upon completion will be recorded using both left and right hand, separately. |
baseline visit
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Data may be shared upon request for up to 6 years beyond completion of the trial based on methods/proposal approved by both parties' institutional review committees. Individual participant data that underlie the results of the trial may be shared after de-identification (text, tables, figures, and appendices). Additional documents available per request include: study protocol, statistical analysis plan, and informed consent. Requests should be directed to Dr. Marielle Engelen (mpkj.engelen@ctral.org).
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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