- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01828229
Consequences of Human Inactivity
Epidemiological studies as well as both longitudinal animal and human inactivity studies indicate that low physical activity is associated with the pathophysiology of type 2 diabetes mellitus (T2DM) and obesity, and recently it has been estimated that physical inactivity (worldwide) causes 7% of the burden of disease related to e.g. T2DM. Physical inactivity, a high energy dietary intake, and T2DM are also associated with dementia, depression, and impaired cognitive function. It is critical that we understand how inactivity alters body composition, glucose and lipid metabolism, and cognitive function, if normal physical activity can prevent these changes, and if there are any differences between sexes.
The present protocol is divided in several in several sub-studies:
- To test whether and how a physically inactive lifestyle will influence body composition, glucose and lipid metabolism, and cognitive function.
- To test whether normal physical activity can prevent the deleterious effect of a physically inactive lifestyle despite a high-caloric intake.
- To test whether the influence of a physically inactive lifestyle combined with a high-caloric intake differs between sexes.
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Copenhagen, Danmark
- Center og inflammation and metabolism, Rigshospitalet
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Normal physical active
- Healthy
- 18-40 y of age
- Non-smokers
Exclusion Criteria:
- Pregnancy
- Diabetes in family
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: female inactivity and hypercaloric diet
inactivity and hypercaloric diet in women for two weeks
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female inactivity and hypercaloric diet for 2 weeks
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Eksperimentell: inactivity
Inactivity for two weeks
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inactivity for 2 weeks
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Eksperimentell: inactivity and hypercaloric diet
inactivity and hypercaloric diet for two weeks
|
inactivity and hypercaloric diet for 2 weeks
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Eksperimentell: normal activity and hypercaloric diet
Normal activity and hypercaloric diet for two weeks
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normal activity and hypercaloric diet for 2 weeks
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Aktiv komparator: inactivity and iso-caloric diet
inactivity and iso-caloric diet for two weeks
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inactivity and iso-caloric diet for 2 weeks
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Insulin sensitivity
Tidsramme: 2 weeks
|
Area under the curve of plasma glucose and insulin levels during an oral glucose tolerance test
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2 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
visceral adiposity
Tidsramme: 2 weeks
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Amount of visceral fat is determined by MRI scans
|
2 weeks
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Cognitive function
Tidsramme: 2 weeks
|
Assessed by the Conner's Continuous Performance Test II 2000
|
2 weeks
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aerobic fitness
Tidsramme: 2 weeks
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maximal oxygen uptake (VO2max) was measured during an incremental exercise test performed on a cycle ergometer
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2 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Olsen RH, Krogh-Madsen R, Thomsen C, Booth FW, Pedersen BK. Metabolic responses to reduced daily steps in healthy nonexercising men. JAMA. 2008 Mar 19;299(11):1261-3. doi: 10.1001/jama.299.11.1259. No abstract available.
- Krogh-Madsen R, Thyfault JP, Broholm C, Mortensen OH, Olsen RH, Mounier R, Plomgaard P, van Hall G, Booth FW, Pedersen BK. A 2-wk reduction of ambulatory activity attenuates peripheral insulin sensitivity. J Appl Physiol (1985). 2010 May;108(5):1034-40. doi: 10.1152/japplphysiol.00977.2009. Epub 2009 Dec 31. Erratum In: J Appl Physiol. 2010 May;108(5):1034.
- Knudsen SH, Hansen LS, Pedersen M, Dejgaard T, Hansen J, Hall GV, Thomsen C, Solomon TP, Pedersen BK, Krogh-Madsen R. Changes in insulin sensitivity precede changes in body composition during 14 days of step reduction combined with overfeeding in healthy young men. J Appl Physiol (1985). 2012 Jul;113(1):7-15. doi: 10.1152/japplphysiol.00189.2011. Epub 2012 May 3. Erratum In: J Appl Physiol (1985). 2015 Feb 15;118(4):504.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H-4-2009-082
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Kliniske studier på female inactivity and hypercaloric diet
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University of HawaiiNational Cancer Institute (NCI); National Institutes of Health (NIH); University...Rekruttering