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SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance (SIT LESS 3)

15 de março de 2016 atualizado por: Maastricht University Medical Center

Background of the study:

A sedentary lifestyle and obesity are well known risk factors of type 2 diabetes. The major focus of current guidelines for type 2 diabetes prevention is on energy balance. Physical activity guidelines recommend at least 30 minutes/day of moderate to vigorous physical activity (MVPA). However, no advice is given how the other 23.5 hours of the day should be spent. Several recent epidemiologic studies suggest that excessive sitting, independent of moderate to vigorous physical activity, has detrimental health effects. Another possibility to sit less is by increasing low intensity physical activities as slowly walking and standing. A recent published study of Duvivier and colleagues suggests that sitting less and replacing it by slowly walking and standing has a better effect on insulin action and cardiovascular risk factors than the combination of one hour MVPA per day and sitting the rest of the day in healthy subjects (Duvivier et al. PLOS ONE 2013). Until now this research is not performed in subjects with overweight/obesity.

Objective of the study:

To assess the effect of low intensity physical activity on plasma insulin levels, cognition and mood in subjects with overweight/obesity

Study population:

21 subjects between 40-80 years old with overweight/obesity

Intervention:

2 activity regimes of 4 days: a sitting regime and a "sit less" regime

Visão geral do estudo

Status

Concluído

Tipo de estudo

Intervencional

Inscrição (Real)

24

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Maastricht, Holanda, 6200MD
        • Human Movement Science, Maastricht University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Signed informed consent
  • Men and postmenopausal women: 40-80 years old
  • BMI: 25.0 - 35.0 kg/m2
  • Maximum 2.5 hours of MVPA per week (during last 3 months)
  • Having a general practitioner
  • Agreeing to be informed about medically relevant personal test-results by a physician
  • Accessible veins on arms as determined by examination at screening

Exclusion Criteria:

  • Reported participation in another biomedical trial which may have an effect on insulin sensitivity one month before the pre-study examination or during the study
  • Blood donation in the past three months
  • Reported participation in night shift work 2 weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM.
  • Consumption of >14 (women) or > 21 (men) alcoholic units per week
  • Reported dietary habits: medically prescribed diet, slimming diet;
  • Reported weight loss (>2kg) in the last three months prior to the screening;
  • Not being able to execute at least three (out of four) cognition tests in the training session
  • Not being able to execute the sit less try-out day
  • Being an employee of Unilever or the collaborating research departments in Maastricht University Medical Centre
  • Experimental drug use (during the last 3 months)
  • Use of insulin, oral blood glucose lowering medication (metformin and/or SU-derivatives and/or DPP-IV inhibitors), corticosteroids or vitamin K antagonists in the last 3 months
  • Fasting plasma glucose level > 6.9 mmol/L
  • Medical conditions which make participation in the study not responsible which will be decided by a medical doctor during screening
  • Other clinically relevant abnormalities in clinical chemistry at screening (to be judged by a medical doctor)
  • Mental or physical disability which interferes with physical activity

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Sitting regime
The subjects will follow the sitting regime during four days. Each day: 14 hours sitting, 1 hour walking and 1 hour standing and 8 hours sleeping.
Information already included in arm descriptions
Experimental: Sit Less regime
Subjects will follow the sit less regime during four days. Each day will consist of 9 hours sitting, 4 hours walking, 3 hours standing and 8 hours sleeping. The walking and standing will be done in a minimum of eight bouts with a time interval of >1 hour. The subjects will be instructed to walk on a slow pace, i.e. 2-3 km/h, which is comparable to walking during shopping, walking to the office etc.
Information already included in arm descriptions

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Plasma insulin levels (measured as area under the curve during an oral glucose tolerance test)
Prazo: one day after each regime
To assess the effect of low intensity physical activity (LIPA) on plasma insulin levels (as measured as area under the curve during an oral glucose tolerance test)
one day after each regime

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Insulin sensitivity (measured as Matsuda combined insulin sensitivity index during an oral glucose tolerance test)
Prazo: one day after each regime
To assess the effect of LIPA on insulin sensitivity
one day after each regime
Plasma C-peptide
Prazo: one day after each regime
To assess the effect of LIPA on plasma C-peptide
one day after each regime
Plasma glucose levels
Prazo: one day after each regime
To assess the effect of LIPA on plasma glucose levels
one day after each regime
Plasma triglycerides
Prazo: one day after each regime
To assess the effect of LIPA on plasma triglycerides
one day after each regime
Plasma total cholesterol
Prazo: one day after each regime
To assess the effect of LIPA on plasma total cholesterol
one day after each regime
Plasma non-HDL cholesterol
Prazo: one day after each regime
To assess the effect of LIPA on plasma non-HDL cholesterol
one day after each regime
Plasma HDL cholesterol
Prazo: one day after each regime
To assess the effect of LIPA on plasma HDL cholesterol
one day after each regime
Plasma LDL cholesterol
Prazo: one day after each regime
To assess the effect of LIPA on plasma LDL cholesterol
one day after each regime
Plasma free fatty acids
Prazo: one day after each regime
To assess the effect of LIPA on plasma free fatty acids
one day after each regime
Plasma apolipoprotein B
Prazo: one day after each regime
To assess the effect of LIPA on plasma apolipoprotein B
one day after each regime
Plasma apolipoprotein A
Prazo: one day after each regime
To assess the effect of LIPA on plasma apolipoprotein A
one day after each regime
Mood (measured by the Affect Grid mood scale)
Prazo: 2 days: last day of each regime and one day after each regime
To assess the effect of LIPA on mood
2 days: last day of each regime and one day after each regime
Attention (measured by the Attention Network Task)
Prazo: one day after each regime before and after the oral glucose tolerance test
To assess the effect of LIPA on attention
one day after each regime before and after the oral glucose tolerance test
Executive Function (measured by the Trail Making Test)
Prazo: one day after each regime before and after the oral glucose tolerance test
To assess the effect of LIPA on executive function
one day after each regime before and after the oral glucose tolerance test
Memory (measured by the Rey Auditory Verbal Learning Task)
Prazo: one day after each regime before and after the oral glucose tolerance test
To assess the effect of LIPA on memory
one day after each regime before and after the oral glucose tolerance test
Quality of life (measured by the Gill 32-item questionnaire)
Prazo: last day of each regime
To assess the effect of LIPA on quality of life
last day of each regime
Sleep (measured by the 10-item Pittsburgh Sleep Quality Index)
Prazo: last day of each regime
To assess the effect of LIPA on sleep
last day of each regime
Plasma C-reactive protein
Prazo: one day after each regime
To assess the effect of LIPA on plasma C-reactive protein
one day after each regime
Plasma interleukin 1
Prazo: one day after each regime
To assess the effect of LIPA on plasma interleukin 1
one day after each regime
Plasma interleukin 6
Prazo: one day after each regime
To assess the effect of LIPA on plasma interleukin 6
one day after each regime
Plasma TNF-alpha
Prazo: one day after each regime
To assess the effect of LIPA on plasma TNF-alpha
one day after each regime
Plasma interferon gamma
Prazo: one day after each regime
To assess the effect of LIPA on plasma interferon gamma
one day after each regime
Plasma ICAM-1
Prazo: one day after each regime
To assess the effect of LIPA on plasma ICAM-1
one day after each regime
Plasma VCAM
Prazo: one day after each regime
To assess the effect of LIPA on plasma VCAM
one day after each regime
Plasma serum amyloid A (SAA)
Prazo: one day after each regime
To assess the effect of LIPA on plasma SAA
one day after each regime
Plasma E-selectine
Prazo: one day after each regime
To assess the effect of LIPA on plasma E-selectine
one day after each regime
Plasma von Willebrand factor (vWF)
Prazo: one day after each regime
To assess the effect of LIPA on plasma vWF
one day after each regime
Plasma PAI-1
Prazo: one day after each regime
To assess the effect of LIPA on plasma PAI-1
one day after each regime
To explore the association between plasma glucose, plasma insulin, insulin sensitivity and mood, cognitive performance, quality of life and sleep
Prazo: one day after each regime
one day after each regime
Blood pressure
Prazo: one day after each regime
one day after each regime
Heart rate
Prazo: one day after each regime
one day after each regime

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Colaboradores

Investigadores

  • Investigador principal: Hans H Savelberg, PhD, Maastricht University Hospital

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de fevereiro de 2015

Conclusão Primária (Real)

1 de setembro de 2015

Conclusão do estudo (Real)

1 de setembro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

19 de fevereiro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de março de 2015

Primeira postagem (Estimativa)

20 de março de 2015

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

16 de março de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de março de 2016

Última verificação

1 de março de 2016

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 143046
  • NL50688.068.14 (Identificador de registro: Medical Ethical Committee Maastricht University Hospital / University of Maastricht)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Physical activity regime

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