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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02130154
Other study ID # NL 42422.018.12 METC 2012.319
Secondary ID
Status Completed
Phase N/A
First received March 20, 2014
Last updated April 30, 2014
Start date May 2013
Est. completion date March 2014

Study information

Verified date April 2014
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial 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 young and elderly subjects, as an explanation for the diminished metabolic brown adipose tissue activity in the elderly.

The investigators hypothesis is that sympathetic nervous system activity in the elderly is diminished as compared to their younger counterparts as an explanation for the diminished metabolic brown adipose tissue activity in the elderly.


Description:

The sympathetic nervous system is the primary activator of Brown Adipose Tissue.

Elderly are known to have less metabolically active brown adipose tissue as compared to their younger 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 elderly 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 young and older subjects.

sympathetic nervous system activity will be measured using 123I-metaiodobenzylguanidine single-photon emission computed tomography computed tomography scans, metabolic activity will be measured using 18F- fluorodeoxyglucose positron emission tomography CT scans.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Male

- Caucasian origin

- Subjects should be able and willing to give informed consent

- 18-65 years old

- BMI range of 19-27 kg/m2

Exclusion Criteria:

- Renal failure (creatinine>135mmol/l)

- Daily use of prescription medication

- Prior participation in a research protocol involving radiation exposure in the last 2 years

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
18-FDG PET CT scan and 123I-MIBG SPECT scan


Locations

Country Name City State
Netherlands Academic Medical Center Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in sympathetic stimulation to BAT between young and older 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. No
Secondary 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 young and older individuals The difference in correlation between sympathetic stimulation of BAT as assessed with a MIBG SPECT-CT scan, and BAT activity itself as assessed with 18F-FDG-PET-CT, between young and elderly subjects 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. No
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