Investigating Brown Adipose Tissue Activation in Humans
NCT ID: NCT01935791
Last Updated: 2021-05-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2013-07-31
2018-11-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle
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.
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle
Temperature
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon
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.
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon
Hormone
Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative
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.
Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative
Temperature
Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control
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.
Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control
Hormone
Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control
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.
Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control
Hormone
Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon
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.
Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon
hormone
Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control
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.
Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control
hormone
Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control
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.
Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control
hormone
Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon
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
Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon
Hormone
Interventions
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Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle
Temperature
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon
Hormone
Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative
Temperature
Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control
Hormone
Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control
Hormone
Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon
hormone
Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control
hormone
Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control
hormone
Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon
Hormone
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* recreational drug use
* participation in other trials within the preceding 2 months
* blood donation within 3 months of study participation
18 Years
ALL
Yes
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Waljit Dhillo
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Imperial College London
London, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Thermal Imaging Is a Noninvasive Alternative to PET/CT for Measurement of Brown Adipose Tissue Activity in Humans
Other Identifiers
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13HH0688
Identifier Type: -
Identifier Source: org_study_id
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