- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02173834
Brown Adipose Tissue and Body Mass Index
Activation of Brown Adipose Tissue in Lean and Obese Men
In this study the investigators aim to investigate whether the sympathetic stimulation of BAT, as assessed with a 123I-metaiodobenzylguanidine single-photon emission computed tomography computed tomography scan, differs between lean and obese individuals, as an explanation for the diminished metabolic brown adipose tissue activity in obese subjects.
The investigators hypothesis is that sympathetic nervous system activity in the obese is diminished as compared to their leaner counterparts as an explanation for the diminished metabolic brown adipose tissue activity in the obese.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
The sympathetic nervous system is the primary activator of Brown Adipose Tissue.
Obese humans are known to have less metabolically active brown adipose tissue as compared to their leaner counterparts.
The reason for this diminished metabolic brown adipose tissue activity is unknown.
However, a lower sympathetic nervous system activation to brown adipose tissue in the obese might explain a diminished metabolic brown adipose tissue.
Therefore, in this study, both the sympathetic nervous system activation to brown adipose tissue and the metabolic activity will be measured in lean and obese subjects.
sympathetic nervous system activity will be measured using 123I-metaiodobenzylguanidine single-photon emission computed tomography scans, metabolic activity will be measured using 18F- fluorodeoxyglucose positron emission tomography CT scans.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Amsterdam, Nederland, 1105AZ
- Academic Medical Center
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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:
- Male
- Caucasian origin
- Subjects should be able and willing to give informed consent
- 18-40 years old
- BMI range of 19-25 kg/m2 (lean study subjects) or 28-40 kg/m2 (obese study subjects)
Exclusion Criteria:
- Renal failure (creatinine>135mmol/l)
- Daily use of prescription medication
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: Lean subjects
Lean, young, healthy, Caucasian, male subjects
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Annen: Obese subjects
Obese, Young, Healthy, Caucasian, male subjects
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Difference in sympathetic stimulation to BAT between lean and obese individuals
Tidsramme: Participants will be followed for a mean duration of 2 weeks (the maximal time period between the two scans) The outcome measurements will be assessed when the last subject has been scanned approximately one year after starting the trial
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Participants will be followed for a mean duration of 2 weeks (the maximal time period between the two scans) The outcome measurements will be assessed when the last subject has been scanned approximately one year after starting the trial
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Difference in correlation between sympathetic stimulation of BAT as assessed with 123I-MIBG SPECT scans and metabolic BAT activity as assessed with 18F-Fluorodeoxyglucose(FDG)- positron emission tomography(PET)-CT scan in lean and obese individuals
Tidsramme: Participants will be followed for a mean duration of 2 weeks (the maximal time period between the two scans) The outcome measurements will be assessed when the last subject has been scanned approximately one year after starting the trial.
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The difference in correlation between sympathetic stimulation of BAT and metabolic BAT activity between lean and obese individuals.
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Participants will be followed for a mean duration of 2 weeks (the maximal time period between the two scans) The outcome measurements will be assessed when the last subject has been scanned approximately one year after starting the trial.
|
Samarbeidspartnere og etterforskere
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
- NL41577.018.12 METC 2012.214
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