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SIT LESS 2: Effect of Sitting Less on Glucose Regulation in People With Diabetes Mellitus Type 2 (SIT LESS 2)

15. mars 2016 oppdatert av: Maastricht University Medical Center

Introduction: Changes in lifestyle are responsible for an important part of the type 2 diabetes epidemic of the last decennia. Current guidelines for physical activity focus mainly on high energy expenditure advising 30 minutes per day moderate to vigorous physical activity (most often physical exercise). Recent studies suggest that sitting has negative metabolic effects independent of the time spent exercising (Duvivier et al. PLOS ONE 2013).

Low intensity physical activity (LIPA) -such as walking and standing- has been suggested to be an alternative to decrease the hyperglycaemic effect of sitting. Compared to exercise, LIPA might be a more feasible strategy. But, it remains to be determined whether reducing sitting time by replacing it by LIPA, results in lower 24 hour blood glucose levels and less blood glucose fluctuations (glycaemic variability) in type 2 diabetes patients and whether these effects are independent of the increase in energy expenditure

Methods: The study population will involve 19 people with type 2 diabetes (BMI: 25-35 kg/m2) who perform no, or only little, exercise and who are treated with diet only or with oral blood glucose lowering medication. They will perform three regimes of each four days: 1) a sitting regime, 2) an exercise regime and a 3) sit less regime. Daily energy expenditure of the exercise regime will be identical to that of the sit less regime. Sitting, walking and standing will be objectively measured by a 24 hour physical activity monitor. The energy spent during exercise will be standardised and quantified by using a bicycle ergometer; energy intake will be standardised as well. During each regime blood glucose will be measured with a 24 hour continuous glucose sensor.

Studieoversikt

Status

Fullført

Forhold

Studietype

Intervensjonell

Registrering (Faktiske)

19

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Limburg
      • Maastricht, Limburg, Nederland, 6200 MD
        • Human Movement Science, Maastricht University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Signed informed consent
  • Men and women: 40-75 years old
  • Diabetes mellitus type 2, developed after the age of 40 years old
  • Treatment with diet or oral blood glucose lowering medication (metformin and/or SU-derivatives and/or DPP-IV inhibitors)
  • HbA1c: < 10%
  • BMI: 25.0 - 35.0 kg/m2
  • Maximum 2.5 hours of MVPA per week (during last 3 months)
  • Internet availability on a daily basis

Exclusion Criteria:

  • Pregnancy or intention of becoming pregnant
  • Alcohol use: > 2 units per day (during the last 3 months)
  • Experimental drug use (during the last 3 months)
  • Use of insulin, corticosteroids, vitamin K antagonists and immunosuppressive drugs in the last 3 months
  • Triglyceride level > 10.0 mmol/L
  • Fasting plasma glucose level > 10 mmol/L
  • Heart failure NYHA 3 or higher
  • Angina pectoris or signs of cardiac ischemia during exercise testing
  • COPD Gold 3 or higher
  • Glomerular filtration rate (GFR) < 30 ml/min
  • Diagnosis of active cancer (not cancer in the past that is cured)
  • Diabetes mellitus type 1
  • Intermittent claudication with a walking distance < 500 meter
  • Not able to cycle for ± 45 minutes, as judged from the incremental exhaustive exercise bicycle-ergometer test at Visit 1
  • Based on historical information not able to walk for 3 hours per day and stand for 4 hours per day
  • Mental or physical disability which makes physical activity not possible
  • Participation in a clinical trial with medication use (in the last 3 months)
  • Severe loss of vision
  • Active foot ulcer or venous leg ulcer

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Sitting regime
The subjects will follow the sitting regime during four days. Each day: 14 hours sitting, 1 hour walking and 1 hour standing for daily care and 8 hours sleeping or lying.
Eksperimentell: Sit Less regime
Subjects will follow the sit less regime during four days. Each day will consist of 3 hours walking, 4 hours standing, 9 hours sitting and 8 hours sleeping or lying. The additional 2 hours of walking and 3 hours of standing, compared to the sitting regime, will be done in a minimum of four 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.
Eksperimentell: Exercise regime
Subjects will follow the exercise regime during four days. Each day will consist of 13 hours and 15 minutes sitting, ± 45 minutes supervised cycling on an ergometer, 1 hour walking and 1 hour standing for daily care and 8 hours sleeping or lying.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Mean 24 hour glucose concentration
Tidsramme: during the last 24 hours of an activity regime
during the last 24 hours of an activity regime

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total duration (minutes) of hyperglycaemia (glucose > 10 mmol/L)
Tidsramme: during the last 24 hours of an activity regime
during the last 24 hours of an activity regime
Mean 24 hour glucose concentration
Tidsramme: during a whole activity regime
during a whole activity regime
Total duration of hyperglycaemia (glucose > 10 mmol/L)
Tidsramme: during a whole activity regime
during a whole activity regime
Area under the curve of hyperglycaemia (glucose > 10 mmol/L)
Tidsramme: during the last 24 hours of an activity regime
during the last 24 hours of an activity regime
Glucose variability measured as SD divided by mean
Tidsramme: the last 24 hours of each regime
the last 24 hours of each regime
Total duration of hypoglycaemia (glucose ≤ 3.9 mmol/L)
Tidsramme: during a whole activity regime
during a whole activity regime
Fasting total cholesterol
Tidsramme: one day after each activity regime
one day after each activity regime
Non-HDL cholesterol
Tidsramme: one day after each activity regime
one day after each activity regime
HDL cholesterol
Tidsramme: one day after each activity regime
one day after each activity regime
LDL cholesterol
Tidsramme: one day after each activity regime
one day after each activity regime
Triglycerides
Tidsramme: one day after each activity regime
one day after each activity regime
Apolipoprotein B
Tidsramme: one day after each activity regime
one day after each activity regime
Apolipoprotein A
Tidsramme: one day after each activity regime
one day after each activity regime
Free fatty acids
Tidsramme: one day after each activity regime
one day after each activity regime
Fasting glucose
Tidsramme: one day after each activity regime
one day after each activity regime
Fasting insulin
Tidsramme: one day after each activity regime
one day after each activity regime
Fasting C-peptide
Tidsramme: one day after each activity regime
one day after each activity regime
Fasting CRP
Tidsramme: one day after each activity regime
one day after each activity regime
Fasting IL-6
Tidsramme: one day after each activity regime
one day after each activity regime
Fasting IL-1
Tidsramme: one day after each activity regime
one day after each activity regime
Homeostatic model assessment 2 (HOMA2)
Tidsramme: one day after each activity regime
to assess insulin sensitivity
one day after each activity regime

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Nicolaas C Schaper, MD PhD, Maastricht University Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2015

Primær fullføring (Faktiske)

1. mai 2015

Studiet fullført (Faktiske)

1. mai 2015

Datoer for studieregistrering

Først innsendt

22. januar 2015

Først innsendt som oppfylte QC-kriteriene

19. februar 2015

Først lagt ut (Anslag)

25. februar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

16. mars 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. mars 2016

Sist bekreftet

1. mars 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 13-2-050
  • NL45498.068.13 (Registeridentifikator: Medical Ethical Committee Maastricht University Hospital / University of Maastricht)

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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