Investigating Brown Adipose Tissue Activation in Humans
1 other identifier
interventional
11
1 country
1
Brief Summary
The purpose of this study is to determine what can activate brown adipose tissue (BAT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
1 active site
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
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 25, 2013
CompletedFirst Posted
Study publicly available on registry
September 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2018
CompletedResults Posted
Study results publicly available
May 18, 2021
CompletedMay 18, 2021
May 1, 2021
5.4 years
July 25, 2013
June 6, 2019
May 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
2hours
Study Arms (9)
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle
ACTIVE COMPARATORVisit 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
EXPERIMENTALVisit 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 COMPARATORVisit 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
EXPERIMENTALVisit 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
EXPERIMENTALVisit 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
EXPERIMENTALVisit 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
EXPERIMENTALVisit 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
EXPERIMENTALVisit 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
EXPERIMENTALVisit 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
Interventions
Temperature
Hormone
Temperature
Hormone
Hormone
hormone
hormone
hormone
Hormone
Eligibility Criteria
You may qualify if:
- aged \>18 years
You may not qualify if:
- medical conditions
- recreational drug use
- participation in other trials within the preceding 2 months
- blood donation within 3 months of study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College London
London, United Kingdom
Related Publications (1)
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.
PMID: 26434748RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Chioma Izzi-Engbeaya
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Waljit Dhillo
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2013
First Posted
September 5, 2013
Study Start
July 1, 2013
Primary Completion
November 5, 2018
Study Completion
November 5, 2018
Last Updated
May 18, 2021
Results First Posted
May 18, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share