NCT02130154

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
Last Updated

May 5, 2014

Status Verified

April 1, 2014

Enrollment Period

10 months

First QC Date

March 20, 2014

Last Update Submit

April 30, 2014

Conditions

Keywords

Brown adipose TissueAgeingSympathetic Nervous StimulationObesity

Outcome Measures

Primary Outcomes (1)

  • 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.

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 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.

Study Arms (2)

Young males

Healthy, Lean, Caucasian, Young males

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

Old males

Healthy, Lean, Caucasian, Older males

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

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy Caucasian Males

You may qualify if:

  • Male
  • Caucasian origin
  • Subjects should be able and willing to give informed consent
  • years old
  • BMI range of 19-27 kg/m2

You may not qualify if:

  • Renal failure (creatinine\>135mmol/l)
  • Daily use of prescription medication
  • Prior participation in a research protocol involving radiation exposure in the last 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 20, 2014

First Posted

May 5, 2014

Study Start

May 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 5, 2014

Record last verified: 2014-04

Locations