Brown Adipose Tissue and Body Mass Index

June 24, 2014 updated by: F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • Academic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lean subjects
Lean, young, healthy, Caucasian, male subjects
Other: 18F- fluorodeoxyglucose-positron emission tomography Computed Tomography scan and 123I-metaiodobenzylguanidine-single-photon emission computed tomography scan
Other: Obese subjects
Obese, Young, Healthy, Caucasian, male subjects
Other: 18F- fluorodeoxyglucose-positron emission tomography Computed Tomography scan and 123I-metaiodobenzylguanidine-single-photon emission computed tomography scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in sympathetic stimulation to BAT between lean and obese individuals
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
The difference in correlation between sympathetic stimulation of BAT and metabolic BAT activity 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

June 25, 2014

Last Update Submitted That Met QC Criteria

June 24, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL41577.018.12 METC 2012.214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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