Brown Adipose Tissue and Body Mass Index
Activation of Brown Adipose Tissue in Lean and Obese Men
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Mar 2013
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 20, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedJune 25, 2014
June 1, 2014
8 months
March 20, 2014
June 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in sympathetic stimulation to BAT between lean and obese individuals
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
Secondary Outcomes (1)
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
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.
Study Arms (2)
Lean subjects
OTHERLean, young, healthy, Caucasian, male subjects
Obese subjects
OTHERObese, Young, Healthy, Caucasian, male subjects
Interventions
Eligibility Criteria
You may qualify if:
- Male
- Caucasian origin
- Subjects should be able and willing to give informed consent
- years old
- BMI range of 19-25 kg/m2 (lean study subjects) or 28-40 kg/m2 (obese study subjects)
You may not qualify if:
- Renal failure (creatinine\>135mmol/l)
- Daily use of prescription medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic Medical Center
Amsterdam, 1105AZ, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
March 20, 2014
First Posted
June 25, 2014
Study Start
March 1, 2013
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
June 25, 2014
Record last verified: 2014-06