- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03556410
Sleep, Exercise and Insulin Sensitivity
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Experimental Design: Subjects will have preliminary screening tests. Two conditions (with/without exercise) will be completed in a randomized, crossover design. Subjects will wear an activity monitor (actigraph) and sleep monitor (actiwatch) for 14 days. For the first 7 days this is the lead in period for us to get baseline sleep day. For the following 5 days they will be asked to reduce their sleep with a specified bed time (ie. 11 pm - 5 am) followed by 2 days of ad libitum sleep hours, totaling 14 days for each condition. On one condition we will let them do their usual physical active and on the other condition during the shortened sleep they will be asked to exercise for 45 min each day at a moderate intensity (65% VO2max). Meal tests will be assessed after 7 days of normal habits, after 5 days of sleep deprivation, and after 2 days of ad libitum sleep, totaling 6 meal tolerance tests throughout the entirety of the study. Testing will be conducted at the MU Physical Activity and Wellness (MUPAW) center in Gwynn Hall and in McKee Gymnasium. Sleep logs will be done for 3 days prior to the meal test days and food diaries will be done 4 days prior.
Visit 1: Subjects will be provided a verbal explanation of the study and will sign the informed consent if interested. They will then complete questionnaires assessing health history, sleep, and physical activity habits. A DXA scan and anthropometrics will also be recorded. Participants will also perform a maximal peak oxygen consumption test (VO2max) on a treadmill for calculations during exercise regimen, 65% VO2max. A resting blood pressure will be measured three times with a sphygmomanometer. A mask will be securely fitted to the subject's face, covering the nose and mouth, and connected to the Parvo Medics TrueOne 2400 (Parvo Medics, Sandy, UT) metabolic cart via a flexible hose to monitor carbon dioxide expulsion and oxygen consumption. Heart rate will be monitored through a polar heart rate monitor chest strap (Polar Elctro, Kempele, Finland). Subjects will be sent home with a pulse oximeter to sleep with to ensure the subjects do not have sleep apnea.
Visit 2: Subjects will collect physical activity monitor (actigraph) and sleep monitor (actiwatch) along with surveys to fill out each day about dietary consumption, sleep habits and physical activity, lasting for 14 days.
Visit 3-5: Subjects will have their resting energy expenditure (REE) measured and then do a meal test. Subjects will arrive at MUPAW at ~7 am, following at least a 10 hour fast, abstain from caffeine for >10 hours and alcohol for 24 hours prior to arriving.
REE: A ParvoMedics TrueOne2400 metabolic measurement system (Sandy Lake, UT) will be used to measure REE. The REE measurement will occur in the morning after an overnight fast and after ingestion of the meal during testing. During the REE, participants will lay supine in a recliner for 30 min while all expired air is collected in a canopy that will be placed over the participants head and analyzed for O2 and CO2 content. The participants will be able to breath room air normally during the procedure. Expired air will be collected and the O2 and CO2 values in the expired air will be converted to a REE estimate using the ParvoMedics software.
Meal test: An IV catheter will be placed in a forearm vein (usually the antecubital vein). A mixed meal tolerance test will consist of a commercially available shake (16 ounces) that will be consumed within 10 minutes. Blood samples (~5 mL) will be collected over a 3 hour period from the start of the test meal ingestion.
Visit 6: Repeat of Visit 2.
Visit 7-9: Repeat of Visit 3-5. Exercise Sessions will be at McKee Gymnasium which will last 45 minutes for 5 days. A mask will be used to monitor oxygen consumption for 10 minutes at the start of the session to ensure appropriate work load.
Subjects will be reminded not to do any distance driving during their 5 days of shortened sleep.
2. Blinding, including justification for blinding or not blinding the trial. Describe un-blinding procedures.
Participants will be told at the beginning of the condition if they are going to be in the exercise condition or just being monitored for physical activity.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Missouri
-
Columbia, Missouri, Estados Unidos, 65211
- University of Missouri
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Overweight and obese men and women
- BMI of 25-35 kg/m2
- normally active (>5000 steps per day)
- normal sleeping habits of 7-9 hours per night
Exclusion Criteria:
- type 2 diabetics
- diagnosed with cardiovascular disease
- hypertensive
- smokers
- pregnant
- taking lipid-lowering medications
- have any recent changes in hormonal birth control
- night shift workers or take regular daytime naps
- on any medications known to impact metabolism, appetite, or sleep
- have any allergies to milk and soy
- sleep apnea or other sleep disorders
- if the 7 days of sleep monitoring prior to sleep restriction period shows inconsistent sleep hours outside of 7-9 hours per night.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: sleep
Subject will undergo 5 days of shortened sleep and then 2 days of ad libitum sleep.
|
Shortened sleep will be requested of all subjects.
During this time normal physical activity will be monitored.
|
|
Experimental: sleep+exercise
Subject will undergo 5 days of shortened sleep but also have 45 min of moderate exercise/day and then 2 days of ad libitum sleep
|
Shortened sleep will be requested of all subjects.
During this time normal physical activity will be monitored.
Shortened sleep will be requested of all subjects.
During this time normal physical activity will be monitored and 45 min of exercise will be required during the shortened sleep days .
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
glucose tolerance
Prazo: 3 hour glucose before the shortened sleep, 5 days after the shortened sleep and after 2 days of ad libitum sleep
|
integrated area under the curve
|
3 hour glucose before the shortened sleep, 5 days after the shortened sleep and after 2 days of ad libitum sleep
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
insulin
Prazo: 3 hour insulin before the shortened sleep, 5 days after the shortened sleep and after 2 days of ad libitum sleep
|
integrated area under the curve
|
3 hour insulin before the shortened sleep, 5 days after the shortened sleep and after 2 days of ad libitum sleep
|
|
FFA
Prazo: fasting values at the beginning of the OGTT
|
fasting FFA concentrations
|
fasting values at the beginning of the OGTT
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- Sleep and Exercise
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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