- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Amsterdam, Olanda, 1105AZ
- Academic Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: Lean subjects
Lean, young, healthy, Caucasian, male subjects
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Altro: Obese subjects
Obese, Young, Healthy, Caucasian, male subjects
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Difference in sympathetic stimulation to BAT between lean and obese individuals
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NL41577.018.12 METC 2012.214
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su 18F- fluorodeoxyglucose-positron emission tomography Computed Tomography scan and 123I-metaiodobenzylguanidine-single-photon emission computed tomography scan
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National Cancer Institute (NCI)Attivo, non reclutanteLinfoma da versamento primario | Neoplasia a cellule BStati Uniti