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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 mars 2016 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

Type d'étude

Interventionnel

Inscription (Réel)

24

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Maastricht, Pays-Bas, 6200MD
        • Human Movement Science, Maastricht University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Expérimental: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Plasma insulin levels (measured as area under the curve during an oral glucose tolerance test)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Insulin sensitivity (measured as Matsuda combined insulin sensitivity index during an oral glucose tolerance test)
Délai: one day after each regime
To assess the effect of LIPA on insulin sensitivity
one day after each regime
Plasma C-peptide
Délai: one day after each regime
To assess the effect of LIPA on plasma C-peptide
one day after each regime
Plasma glucose levels
Délai: one day after each regime
To assess the effect of LIPA on plasma glucose levels
one day after each regime
Plasma triglycerides
Délai: one day after each regime
To assess the effect of LIPA on plasma triglycerides
one day after each regime
Plasma total cholesterol
Délai: one day after each regime
To assess the effect of LIPA on plasma total cholesterol
one day after each regime
Plasma non-HDL cholesterol
Délai: one day after each regime
To assess the effect of LIPA on plasma non-HDL cholesterol
one day after each regime
Plasma HDL cholesterol
Délai: one day after each regime
To assess the effect of LIPA on plasma HDL cholesterol
one day after each regime
Plasma LDL cholesterol
Délai: one day after each regime
To assess the effect of LIPA on plasma LDL cholesterol
one day after each regime
Plasma free fatty acids
Délai: one day after each regime
To assess the effect of LIPA on plasma free fatty acids
one day after each regime
Plasma apolipoprotein B
Délai: one day after each regime
To assess the effect of LIPA on plasma apolipoprotein B
one day after each regime
Plasma apolipoprotein A
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: last day of each regime
To assess the effect of LIPA on sleep
last day of each regime
Plasma C-reactive protein
Délai: one day after each regime
To assess the effect of LIPA on plasma C-reactive protein
one day after each regime
Plasma interleukin 1
Délai: one day after each regime
To assess the effect of LIPA on plasma interleukin 1
one day after each regime
Plasma interleukin 6
Délai: one day after each regime
To assess the effect of LIPA on plasma interleukin 6
one day after each regime
Plasma TNF-alpha
Délai: one day after each regime
To assess the effect of LIPA on plasma TNF-alpha
one day after each regime
Plasma interferon gamma
Délai: one day after each regime
To assess the effect of LIPA on plasma interferon gamma
one day after each regime
Plasma ICAM-1
Délai: one day after each regime
To assess the effect of LIPA on plasma ICAM-1
one day after each regime
Plasma VCAM
Délai: one day after each regime
To assess the effect of LIPA on plasma VCAM
one day after each regime
Plasma serum amyloid A (SAA)
Délai: one day after each regime
To assess the effect of LIPA on plasma SAA
one day after each regime
Plasma E-selectine
Délai: 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)
Délai: one day after each regime
To assess the effect of LIPA on plasma vWF
one day after each regime
Plasma PAI-1
Délai: 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
Délai: one day after each regime
one day after each regime
Blood pressure
Délai: one day after each regime
one day after each regime
Heart rate
Délai: one day after each regime
one day after each regime

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2015

Achèvement primaire (Réel)

1 septembre 2015

Achèvement de l'étude (Réel)

1 septembre 2015

Dates d'inscription aux études

Première soumission

19 février 2015

Première soumission répondant aux critères de contrôle qualité

16 mars 2015

Première publication (Estimation)

20 mars 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

16 mars 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 mars 2016

Dernière vérification

1 mars 2016

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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