Brown Adipose Tissue and Body Mass Index
Primary Purpose
Obesity, Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
18F- fluorodeoxyglucose-positron emission tomography Computed Tomography scan and 123I-metaiodobenzylguanidine-single-photon emission computed tomography scan
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Brown Adipose Tissue, Weight, Sympathetic Nervous System
Eligibility Criteria
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
Sites / Locations
- Academic Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Lean subjects
Obese subjects
Arm Description
Lean, young, healthy, Caucasian, male subjects
Obese, Young, Healthy, Caucasian, male subjects
Outcomes
Primary Outcome Measures
Difference in sympathetic stimulation to BAT between lean and obese individuals
Secondary Outcome Measures
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
The difference in correlation between sympathetic stimulation of BAT and metabolic BAT activity between lean and obese individuals.
Full Information
NCT ID
NCT02173834
First Posted
March 20, 2014
Last Updated
June 24, 2014
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT02173834
Brief Title
Brown Adipose Tissue and Body Mass Index
Official Title
Activation of Brown Adipose Tissue in Lean and Obese Men
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes Mellitus
Keywords
Brown Adipose Tissue, Weight, Sympathetic Nervous System
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lean subjects
Arm Type
Other
Arm Description
Lean, young, healthy, Caucasian, male subjects
Arm Title
Obese subjects
Arm Type
Other
Arm Description
Obese, Young, Healthy, Caucasian, male subjects
Intervention Type
Other
Intervention Name(s)
18F- fluorodeoxyglucose-positron emission tomography Computed Tomography scan and 123I-metaiodobenzylguanidine-single-photon emission computed tomography scan
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Description
The difference in correlation between sympathetic stimulation of BAT and metabolic BAT activity 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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
12. IPD Sharing Statement
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Brown Adipose Tissue and Body Mass Index
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