Metabolic DiseasesNCT01935791

Investigating Brown Adipose Tissue Activation in Humans

A study of Metabolic Diseases, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine what can activate brown adipose tissue (BAT). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Metabolic Diseases
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited Kingdom
Study dates: Jul 2013to 5 Nov 2018
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

aged >18 years

Who cannot join

medical conditions
recreational drug use
participation in other trials within the preceding 2 months
blood donation within 3 months of study participation

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Imperial College London
London

Other trials in United Kingdom

About this study

The purpose of this study is to determine what can activate brown adipose tissue (BAT).

Read the detailed description

We will investigate different stimuli (i.e. hormones) to determine which can stimulate BAT.

Conditions: Metabolic Diseases
Being tested: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle, Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon, Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative, Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control, Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control
Keywords: Metabolic Diseases
Medical subject headings: Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT VehicleOther
Temperature
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT GlucagonDrug
Hormone
Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negativeOther
Temperature
Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold controlDrug
Hormone
Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm controlDrug
Hormone
Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagonDrug
hormone
Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm controlDrug
hormone
Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold controlDrug
hormone
Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagonDrug
Hormone

Study groups in NCT01935791
Study group	Role	What they receive
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle	Active comparator	Visit 1. Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine. Visit 2 Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst receiving an infusion of gelofusine without a cooling vest. Receives: Other: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon	Experimental	Visit 1. Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine Visit 2 Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min without a cooling vest. Receives: Drug: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon
Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative	Active comparator	Visit 1. Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine. No brown adipose tissue (BAT) identified on visit 1, therefore no visit 2. Receives: Other: Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative
Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control	Experimental	Visit 1- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius. Visit 2 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius. Visit 3 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Receives: Drug: Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control
Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control	Experimental	Visit 1- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius. Visit 2 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Visit 3 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius. Receives: Drug: Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control
Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon	Experimental	Visit 1 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Visit 2 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius. Visit 3 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius. Receives: Drug: Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon
Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control	Experimental	Visit 1 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Visit 2- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees Celsius. Visit 3 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees Celsius. Receives: Drug: Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control
Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control	Experimental	Visit 1- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees Celsius. Visit 2 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees Celsius. Visit 3- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Receives: Drug: Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control
Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon	Experimental	Visit 1 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees Celsius. Visit 2- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Visit 3 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees Celsius Receives: Drug: Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon

What is being measured

The primary outcome is the main question the study is designed to answer.

Brown Adipose Tissue Activation Following Glucagon or Saline Infusion
Period 1 Brown Adipose Tissue (BAT) activation measured using metabolic rate of glucose (MR[gluc]) during F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET-CT) for Cold PET-CT Vehicle vs Warm PET-CT Vehicle vs warm PET-CT Glucagon.
Measured: 2hours
Increase in Energy Expenditure Following Glucagon or Saline Infusion
Period 2 Increase in energy expenditure measured using indirect calorimetry for Cold control vs Warm Control vs Warm Glucagon.
Measured: 2hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 20135 Nov 2018

First posted5 Sep 2013 (estimated)
Study startJul 2013
Primary completion5 Nov 2018
Study completion5 Nov 2018

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01935791
Sponsor's protocol ID: 13HH0688
Status last verified: May 2021
First submitted: 25 Jul 2013
Last updated: 18 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Salem V, Izzi-Engbeaya C, Coello C, Thomas DB, Chambers ES, Comninos AN, Buckley A, Win Z, Al-Nahhas A, Rabiner EA, Gunn RN, Budge H, Symonds ME, Bloom SR, Tan TM, Dhillo WS. Glucagon increases energy expenditure independently of brown adipose tissue activation in humans. Diabetes Obes Metab. 2016 Jan;18(1):72-81. doi: 10.1111/dom.12585. Epub 2015 Nov 20.
PubMed 26434748

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigating Brown Adipose Tissue Activation in Humans
ClinicalTrials.gov ID: NCT01935791
Acronym / sponsor ID: 13HH0688
Conditions: Metabolic Diseases
Keywords: Metabolic Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Study start: Jul 2013
Primary completion: 5 Nov 2018 (actual)
Study completion: 5 Nov 2018 (actual)
First posted: 5 Sep 2013 (estimated)
Results: Posted 18 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine what can activate brown adipose tissue (BAT).

Detailed description

We will investigate different stimuli (i.e. hormones) to determine which can stimulate BAT.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 9

Arm	Type	Receives
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle	Active comparator	Other: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT VehicleVisit 1. Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine. Visit 2 Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst receiving an infusion of gelofusine without a cooling vest.
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon	Experimental	Drug: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT GlucagonVisit 1. Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine Visit 2 Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min without a cooling vest.
Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative	Active comparator	Other: Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negativeVisit 1. Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine. No brown adipose tissue (BAT) identified on visit 1, therefore no visit 2.
Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control	Experimental	Drug: Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold controlVisit 1- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius. Visit 2 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius. Visit 3 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest.
Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control	Experimental	Drug: Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm controlVisit 1- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius. Visit 2 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Visit 3 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius.
Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon	Experimental	Drug: Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagonVisit 1 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Visit 2 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius. Visit 3 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius.
Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control	Experimental	Drug: Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm controlVisit 1 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Visit 2- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees Celsius. Visit 3 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees Celsius.
Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control	Experimental	Drug: Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold controlVisit 1- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees Celsius. Visit 2 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees Celsius. Visit 3- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest.
Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon	Experimental	Drug: Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagonVisit 1 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees Celsius. Visit 2- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Visit 3 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees Celsius

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

aged >18 years

Key exclusion criteria (4 listed)

medical conditions
recreational drug use
participation in other trials within the preceding 2 months
blood donation within 3 months of study participation

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
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT VehicleTemperature	Other	Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT GlucagonHormone	Drug	Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon
Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negativeTemperature	Other	Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative
Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold controlHormone	Drug	Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control
Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm controlHormone	Drug	Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control
Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagonhormone	Drug	Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon
Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm controlhormone	Drug	Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control
Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold controlhormone	Drug	Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control
Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagonHormone	Drug	Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon

Primary outcome

Brown Adipose Tissue Activation Following Glucagon or Saline Infusion
Time frame: 2hours
Period 1 Brown Adipose Tissue (BAT) activation measured using metabolic rate of glucose (MR[gluc]) during F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET-CT) for Cold PET-CT Vehicle vs Warm PET-CT Vehicle vs warm PET-CT Glucagon.
Increase in Energy Expenditure Following Glucagon or Saline Infusion
Time frame: 2hours
Period 2 Increase in energy expenditure measured using indirect calorimetry for Cold control vs Warm Control vs Warm Glucagon.

Results and safety

Results posted to the registry on 18 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle	4	4
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon	4	4
Period 1 Visit 1 - Cold PET-CT Vehicle, no Visit 2 as BAT Negative	3	3
Period 2 - Visit 1 Warm Control Vehicle, Visit 2 Warm Glucagon, Visit 3 Cold Control	0	0
Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold Control , Visit 3 Warm Control	0	0
Period 2 -Visit 1 Cold Control, Visit 2 Warm Control, Visit 3 Warm Glucagon	0	0
Period 2 -Visit 1 Cold Control, Visit 2 Warm Glucagon, Visit 3 Warm Control	0	0
Period 2- Visit 1 Warm Glucagon, Visit 2 Warm Control, Visit 3 Cold Control	0	0
Period 2 -Visit 1 Warm Control, Visit 2 Cold Control, Visit 3 Warm Glucagon	0	0

Primary outcome: Brown Adipose Tissue Activation Following Glucagon or Saline Infusion

Time frame: 2hours. Mean (Standard Deviation). Unit: MR[gluc] umol/kg/min

Measure	Period 1 Cold PET-CT Vehicle n = 8	Period 1 Warm PET-CT Vehicle n = 4	Period 1 Warm PET(CT) Glucagon n = 4
Value	0.074 (0.007)	0.010 (0.003)	0.029 (0.008)

Period 1 Cold PET-CT Vehicle vs Period 1 Warm PET-CT Vehicle vs Period 1 Warm PET(CT) Glucagon: p <0.01, ANOVA

Population analysed: Period 1 Parallel design (3 out of 11 participants did not have BAT activation and therefore they were not included in the analysis). Period 2 Crossover design

Primary outcome: Increase in Energy Expenditure Following Glucagon or Saline Infusion

Time frame: 2hours. Mean (Standard Deviation). Unit: increase in energy expenditure kcal/day

Measure	Period 2 - Cold Control n = 11	Period 2 - Warm Control n = 11	Period 2 -Warm Glucagon n = 11
Value	193.0 (27.2)	41.1 (70)	230.8 (30.1)

Period 2 - Cold Control vs Period 2 - Warm Control vs Period 2 -Warm Glucagon: p <0.001, ANOVA

Population analysed: Period 2 Crossover design

Adverse events

Time frame: 3 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period 1 Visit 1 Cold Vehicle	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Period 1 Visit 2 Warm Glucagon	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Period 1 Visit 2 Warm Vehicle	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Period 2 Cold Control	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Period 2 Warm Control	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Period 2 Warm Glucagon	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26434748Salem V, Izzi-Engbeaya C, Coello C, Thomas DB, Chambers ES, Comninos AN, Buckley A, Win Z, Al-Nahhas A, Rabiner EA, Gunn RN, Budge H, Symonds ME, Bloom SR, Tan TM, Dhillo WS. Glucagon increases energy expenditure independently of brown adipose tissue activation in humans. Diabetes Obes Metab. 2016 Jan;18(1):72-81. doi: 10.1111/dom.12585. Epub 2015 Nov 20.
Thermal Imaging Is a Noninvasive Alternative to PET/CT for Measurement of Brown Adipose Tissue Activity in HumansLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Waljit Dhillo principal investigator

Imperial College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Metabolic Diseases, run by Imperial College London at 1 site in United Kingdom.

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 1 inclusion and 4 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 18 May 2021. 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 Kingdom. 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 18 May 2021). 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?

Brown Adipose Tissue Activation Following Glucagon or Saline Infusion (time frame: 2hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01935791, which also lists 1 linked publication.

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 18 May 2021.