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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 marca 2016 zaktualizowane przez: 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

Przegląd badań

Status

Zakończony

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

24

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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
Eksperymentalny: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Plasma insulin levels (measured as area under the curve during an oral glucose tolerance test)
Ramy czasowe: 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

Miary wyników drugorzędnych

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Współpracownicy

Śledczy

  • Główny śledczy: Hans H Savelberg, PhD, Maastricht University Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lutego 2015

Zakończenie podstawowe (Rzeczywisty)

1 września 2015

Ukończenie studiów (Rzeczywisty)

1 września 2015

Daty rejestracji na studia

Pierwszy przesłany

19 lutego 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 marca 2015

Pierwszy wysłany (Oszacować)

20 marca 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

16 marca 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 marca 2016

Ostatnia weryfikacja

1 marca 2016

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 143046
  • NL50688.068.14 (Identyfikator rejestru: Medical Ethical Committee Maastricht University Hospital / University of Maastricht)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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