- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Amsterdam, Niederlande, 1105AZ
- Academic Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Sonstiges: Lean subjects
Lean, young, healthy, Caucasian, male subjects
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Sonstiges: Obese subjects
Obese, Young, Healthy, Caucasian, male subjects
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Difference in sympathetic stimulation to BAT between lean and obese individuals
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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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
Zeitfenster: 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.
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NL41577.018.12 METC 2012.214
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