- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02394249
SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance (SIT LESS 3)
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
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Maastricht, Pays-Bas, 6200MD
- Human Movement Science, Maastricht University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
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
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 |
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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.
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Information already included in arm descriptions
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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.
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Information already included in arm descriptions
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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
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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)
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one day after each regime
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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
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To assess the effect of LIPA on insulin sensitivity
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one day after each regime
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Plasma C-peptide
Délai: one day after each regime
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To assess the effect of LIPA on plasma C-peptide
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one day after each regime
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Plasma glucose levels
Délai: one day after each regime
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To assess the effect of LIPA on plasma glucose levels
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one day after each regime
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Plasma triglycerides
Délai: one day after each regime
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To assess the effect of LIPA on plasma triglycerides
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one day after each regime
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Plasma total cholesterol
Délai: one day after each regime
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To assess the effect of LIPA on plasma total cholesterol
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one day after each regime
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Plasma non-HDL cholesterol
Délai: one day after each regime
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To assess the effect of LIPA on plasma non-HDL cholesterol
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one day after each regime
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Plasma HDL cholesterol
Délai: one day after each regime
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To assess the effect of LIPA on plasma HDL cholesterol
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one day after each regime
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Plasma LDL cholesterol
Délai: one day after each regime
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To assess the effect of LIPA on plasma LDL cholesterol
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one day after each regime
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Plasma free fatty acids
Délai: one day after each regime
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To assess the effect of LIPA on plasma free fatty acids
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one day after each regime
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Plasma apolipoprotein B
Délai: one day after each regime
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To assess the effect of LIPA on plasma apolipoprotein B
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one day after each regime
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Plasma apolipoprotein A
Délai: one day after each regime
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To assess the effect of LIPA on plasma apolipoprotein A
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one day after each regime
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Mood (measured by the Affect Grid mood scale)
Délai: 2 days: last day of each regime and one day after each regime
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To assess the effect of LIPA on mood
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2 days: last day of each regime and one day after each regime
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Attention (measured by the Attention Network Task)
Délai: one day after each regime before and after the oral glucose tolerance test
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To assess the effect of LIPA on attention
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one day after each regime before and after the oral glucose tolerance test
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Executive Function (measured by the Trail Making Test)
Délai: one day after each regime before and after the oral glucose tolerance test
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To assess the effect of LIPA on executive function
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one day after each regime before and after the oral glucose tolerance test
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Memory (measured by the Rey Auditory Verbal Learning Task)
Délai: one day after each regime before and after the oral glucose tolerance test
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To assess the effect of LIPA on memory
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one day after each regime before and after the oral glucose tolerance test
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Quality of life (measured by the Gill 32-item questionnaire)
Délai: last day of each regime
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To assess the effect of LIPA on quality of life
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last day of each regime
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Sleep (measured by the 10-item Pittsburgh Sleep Quality Index)
Délai: last day of each regime
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To assess the effect of LIPA on sleep
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last day of each regime
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Plasma C-reactive protein
Délai: one day after each regime
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To assess the effect of LIPA on plasma C-reactive protein
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one day after each regime
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Plasma interleukin 1
Délai: one day after each regime
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To assess the effect of LIPA on plasma interleukin 1
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one day after each regime
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Plasma interleukin 6
Délai: one day after each regime
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To assess the effect of LIPA on plasma interleukin 6
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one day after each regime
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Plasma TNF-alpha
Délai: one day after each regime
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To assess the effect of LIPA on plasma TNF-alpha
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one day after each regime
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Plasma interferon gamma
Délai: one day after each regime
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To assess the effect of LIPA on plasma interferon gamma
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one day after each regime
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Plasma ICAM-1
Délai: one day after each regime
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To assess the effect of LIPA on plasma ICAM-1
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one day after each regime
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Plasma VCAM
Délai: one day after each regime
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To assess the effect of LIPA on plasma VCAM
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one day after each regime
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Plasma serum amyloid A (SAA)
Délai: one day after each regime
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To assess the effect of LIPA on plasma SAA
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one day after each regime
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Plasma E-selectine
Délai: one day after each regime
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To assess the effect of LIPA on plasma E-selectine
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one day after each regime
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Plasma von Willebrand factor (vWF)
Délai: one day after each regime
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To assess the effect of LIPA on plasma vWF
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one day after each regime
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Plasma PAI-1
Délai: one day after each regime
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To assess the effect of LIPA on plasma PAI-1
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one day after each regime
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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
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one day after each regime
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Blood pressure
Délai: one day after each regime
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one day after each regime
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Heart rate
Délai: one day after each regime
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one day after each regime
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Hans H Savelberg, PhD, Maastricht University Hospital
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 143046
- NL50688.068.14 (Identificateur de registre: Medical Ethical Committee Maastricht University Hospital / University of Maastricht)
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