- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Copenhagen, Danmark
- Center og inflammation and metabolism, Rigshospitalet
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Normal physical active
- Healthy
- 18-40 y of age
- Non-smokers
Exclusion Criteria:
- Pregnancy
- Diabetes in family
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: female inactivity and hypercaloric diet
inactivity and hypercaloric diet in women for two weeks
|
female inactivity and hypercaloric diet for 2 weeks
|
Experimentell: inactivity
Inactivity for two weeks
|
inactivity for 2 weeks
|
Experimentell: inactivity and hypercaloric diet
inactivity and hypercaloric diet for two weeks
|
inactivity and hypercaloric diet for 2 weeks
|
Experimentell: normal activity and hypercaloric diet
Normal activity and hypercaloric diet for two weeks
|
normal activity and hypercaloric diet for 2 weeks
|
Aktiv komparator: inactivity and iso-caloric diet
inactivity and iso-caloric diet for two weeks
|
inactivity and iso-caloric diet for 2 weeks
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Insulin sensitivity
Tidsram: 2 weeks
|
Area under the curve of plasma glucose and insulin levels during an oral glucose tolerance test
|
2 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
visceral adiposity
Tidsram: 2 weeks
|
Amount of visceral fat is determined by MRI scans
|
2 weeks
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Cognitive function
Tidsram: 2 weeks
|
Assessed by the Conner's Continuous Performance Test II 2000
|
2 weeks
|
aerobic fitness
Tidsram: 2 weeks
|
maximal oxygen uptake (VO2max) was measured during an incremental exercise test performed on a cycle ergometer
|
2 weeks
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H-4-2009-082
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