HealthyNCT02285270
Circadian Brown Adipose Tissue Metabolism
A study testing FDG PET/CT in people with Healthy, run by University of Pennsylvania at 1 site in United States.
Trial summary
Brown adipose tissue is poorly understood fat that can metabolize glucose in order to generate heat. Since activated brown fat has a high metabolic rate, it is of great interest as a potential target to combat obesity. However, the signaling and control of brown fat metabolism is poorly understood. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- FDG PET/CT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 18 years of age and less than 45 years of age
- Able and willing to provide informed consent
- Male gender
- Capable of complying with study procedures and able to lie still in the PET/CT scanner for up to 40 minutes continuously
- Normal fasting glucose (less than 100 mg/dl)
- No evidence of significant concurrent illness
- Follow typical sleep/wake cycle of generally asleep at night and awake during the day
Who cannot join
- Prior surgery or radiation to the head, neck, or upper chest (except surgeries such as tonsillectomy/adenoidectomy/tympanostomy that would not be expected, in the judgement of the investigator, to have disrupted the adipose tissue in the neck or the upper chest)
- Active addiction or illicit drug abuse
- BMI greater than 25
- Employment in the night shift/3rd shift
- Unable to remain in the Clinical and Translational Research Center (CTRC) for entire 24 hour period.
- Unable or unwilling to maintain peripheral intravenous access for up to 24 hours
- Abnormal liver or kidney function (serum creatinine or transaminase levels greater than 1.5 ULN)
- Subject has any other condition or personal circumstance that, in the judgement of the investigator, might interfere with the collection of complete, high quality data
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Study to Investigate Circadian Variations in Brown Adipose Tissue Metabolism in Healthy Volunteers.
Brown adipose tissue is poorly understood fat that can metabolize glucose in order to generate heat. Since activated brown fat has a high metabolic rate, it is of great interest as a potential target to combat obesity. However, the signaling and control of brown fat metabolism is poorly understood. Because brown fat uses glucose as its energy source, brown fat metabolism can be imaged with PET/CT using the positron emitting glucose analog F-18 FDG. We have recently shown in mice a striking circadian variation in brown fat metabolism as evidenced by changes in FDG uptake. In this study we endeavor to generate pilot data on a potential circadian variation in brown fat activation in healthy humans.
Read the detailed description
Brown adipose tissue is a form of fat that is able to metabolize glucose in order to generate heat. When active, it can convert a great deal of glucose into thermal energy. Activation of brown fat could potentially help to combat obesity by increasing the basal metabolic rate. However, activation and signaling of brown fat is poorly understood. In a mouse model, we have recently shown that there is significant circadian variation in brown fat activation and have also discovered the gene that is responsible for the circadian changes (Gerhart-Hines et al, Nature 2013). Specifically, we have shown that in wild type mice, brown fat activation is high at night and low during the day. Whether human brown fat activation has a circadian component is currently unknown. Showing that brown fat activation in humans is subject to similar circadian rhythms as in mice would be an important step in understanding the signaling of activation and may help to elucidate potential strategies to control activation. Positron emission tomography/computed tomography (PET/CT) is a hybrid imaging modality that allows imaging positron emitting isotopes such as fluorine-18 (F-18) along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. However, isomerase, the next enzyme in the glycolytic pathway, is inactive on FDG-6P and so it is largely trapped in the cell. Therefore, FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan. Activated brown fat has robust FDG uptake with very intense signal seen. Therefore, FDG PET/CT can be used both to determine whether a person has activated brown fat at the time of the scan as well as to quantify the overall level of metabolism in the fat. Our primary objective is to gather pilot data on the potential presence of circadian variations in brown fat uptake in young, healthy, lean male volunteers. We plan to do this by performing two FDG PET/CT scans 12 hours apart while the patient remains in a temperature and diet controlled environment leading up to both scans. Our primary hypothesis is that brown fat activity will be higher during the day than at night (as human and mouse circadian rhythms are reversed). We will also pair measurement of cortisol with the FDG injections as cortisol levels provide valuable independent information on the circadian rhythm.
- Conditions
- Healthy
- Being tested
- FDG PET/CT
- Keywords
- Circadian rhythm, Adipose tissue, brown, Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PET/CTDevice
PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan.
| Study group | Role | What they receive |
|---|---|---|
| Single group assignment | Other | Diagnostic test/procedure - FDG PET/CT Receives: Device: FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum Standardized Update Value (SUVmax) in Brown Adipose Tissue FDG Uptake in the Neck or Upper Chest on Evening and Imaging Compared to Morning Imaging
Measured: ~12-hours
Secondary outcomes (2)
Correlation Between Cortisol Level and Brown Adipose Tissue FDG Uptake
Measured: ~12-hours
Change in Total Brown Adipose Tissue FDG Uptake as Measured by Total Volume of Segmented Fat Times the Mean Standardized Uptake Value (SUVmean)
Measured: ~12-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Pryma, University of Pennsylvania
- Investigators
- Daniel Pryma, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285270
- Sponsor's protocol ID
- 819607
- Status last verified
- Oct 2016
- First submitted
- 4 Nov 2014
- Last updated
- 7 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate Circadian Variations in Brown Adipose Tissue Metabolism in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02285270
- Acronym / sponsor ID
- 819607
- Conditions
- Healthy
- Keywords
- Circadian rhythm, Adipose tissue, brown, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Posted 17 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brown adipose tissue is poorly understood fat that can metabolize glucose in order to generate heat. Since activated brown fat has a high metabolic rate, it is of great interest as a potential target to combat obesity. However, the signaling and control of brown fat metabolism is poorly understood. Because brown fat uses glucose as its energy source, brown fat metabolism can be imaged with PET/CT using the positron emitting glucose analog F-18 FDG. We have recently shown in mice a striking circadian variation in brown fat metabolism as evidenced by changes in FDG uptake. In this study we endeavor to generate pilot data on a potential circadian variation in brown fat activation in healthy humans.
Detailed description
Brown adipose tissue is a form of fat that is able to metabolize glucose in order to generate heat. When active, it can convert a great deal of glucose into thermal energy. Activation of brown fat could potentially help to combat obesity by increasing the basal metabolic rate. However, activation and signaling of brown fat is poorly understood. In a mouse model, we have recently shown that there is significant circadian variation in brown fat activation and have also discovered the gene that is responsible for the circadian changes (Gerhart-Hines et al, Nature 2013). Specifically, we have shown that in wild type mice, brown fat activation is high at night and low during the day. Whether human brown fat activation has a circadian component is currently unknown. Showing that brown fat activation in humans is subject to similar circadian rhythms as in mice would be an important step in understanding the signaling of activation and may help to elucidate potential strategies to control activation. Positron emission tomography/computed tomography (PET/CT) is a hybrid imaging modality that allows imaging positron emitting isotopes such as fluorine-18 (F-18) along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. However, isomerase, the next enzyme in the glycolytic pathway, is inactive on FDG-6P and so it is largely trapped in the cell. Therefore, FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan. Activated brown fat has robust FDG uptake with very intense signal seen. Therefore, FDG PET/CT can be used both to determine whether a person has activated brown fat at the time of the scan as well as to quantify the overall level of metabolism in the fat. Our primary objective is to gather pilot data on the potential presence of circadian variations in brown fat uptake in young, healthy, lean male volunteers. We plan to do this by performing two FDG PET/CT scans 12 hours apart while the patient remains in a temperature and diet controlled environment leading up to both scans. Our primary hypothesis is that brown fat activity will be higher during the day than at night (as human and mouse circadian rhythms are reversed). We will also pair measurement of cortisol with the FDG injections as cortisol levels provide valuable independent information on the circadian rhythm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group assignment | Other | Device: FDG PET/CTDiagnostic test/procedure - FDG PET/CT |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- At least 18 years of age and less than 45 years of age
- Able and willing to provide informed consent
- Male gender
- Capable of complying with study procedures and able to lie still in the PET/CT scanner for up to 40 minutes continuously
- Normal fasting glucose (less than 100 mg/dl)
Key exclusion criteria (8 listed)
- Prior surgery or radiation to the head, neck, or upper chest (except surgeries such as tonsillectomy/adenoidectomy/tympanostomy that would not be expected, in the judgement of the investigator, to have disrupted the adipose tissue in the neck or the upper chest)
- Active addiction or illicit drug abuse
- BMI greater than 25
- Employment in the night shift/3rd shift
- Unable to remain in the Clinical and Translational Research Center (CTRC) for entire 24 hour period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG PET/CTPET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan. | Device | Single group assignment |
Primary outcome
Change in Maximum Standardized Update Value (SUVmax) in Brown Adipose Tissue FDG Uptake in the Neck or Upper Chest on Evening and Imaging Compared to Morning Imaging
Time frame: ~12-hours
2 secondary outcomes
Correlation Between Cortisol Level and Brown Adipose Tissue FDG Uptake
Time frame: ~12-hours
Change in Total Brown Adipose Tissue FDG Uptake as Measured by Total Volume of Segmented Fat Times the Mean Standardized Uptake Value (SUVmean)
Time frame: ~12-hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The nuclear receptor Rev-erbα controls circadian thermogenic plasticity.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Pryma, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG PET/CT in people with Healthy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximum Standardized Update Value (SUVmax) in Brown Adipose Tissue FDG Uptake in the Neck or Upper Chest on Evening and Imaging Compared to Morning Imaging (time frame: ~12-hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.