Conseqüências metabólicas e funcionais do envelhecimento na saúde e doença
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Laura Ruebush, PhD
- Número de telefone: 979-422-1789
- E-mail: le.ruebush@ctral.org
Estude backup de contato
- Nome: Marielle Engelen, PhD
- Número de telefone: 979-422-1789
- E-mail: mpkj.engelen@ctral.org
Locais de estudo
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Texas
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College Station, Texas, Estados Unidos, 77845
- Recrutamento
- Human Clinical Research Building
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Contato:
- Laura Ruebush, PhD
- E-mail: le.ruebush@ctral.org
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Age-related changes in whole-body protein and amino acid metabolism
Prazo: 2 hours
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Whole-body production rate measured after stable tracer administration |
2 hours
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Age-related changes in whole-body glucose metabolism
Prazo: 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 whole-body fat metabolism
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: baseline visit
|
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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Age-related changes in hand dexterity
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2021-1413
- 82-Aging (Outro identificador: CTRAL)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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).
Informações sobre medicamentos e dispositivos, documentos de estudo
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