Brown Adipose Tissue Activity and Age

Obesity Clinical Trial

Official title:

Brown Adipose Tissue Activity Young and Older Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130154
• Other study ID #: NL 42422.018.12 METC 2012.319
• 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

• Ageing
• Obesity

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