Investigating Brown Adipose Tissue Activation in Humans
Status
Completed
Conditions
Metabolic Diseases
Treatments
Drug: Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon
Drug: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon
Other: Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative
Drug: Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control
Drug: Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon
Other: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle
Drug: Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control
Drug: Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control
Drug: Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control
Details and patient eligibility
About
The purpose of this study is to determine what can activate brown adipose tissue (BAT).
Full description
We will investigate different stimuli (i.e. hormones) to determine which can stimulate BAT.
Enrollment
11 patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- aged >18 years
Exclusion criteria
- medical conditions
- recreational drug use
- participation in other trials within the preceding 2 months
- blood donation within 3 months of study participation
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Single Blind
11 participants in 9 patient groups
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle
Active Comparator group
Description:
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.
Treatment:
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 group
Description:
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.
Treatment:
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 group
Description:
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.
Treatment:
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 group
Description:
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.
Treatment:
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 group
Description:
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.
Treatment:
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 group
Description:
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.
Treatment:
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 group
Description:
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.
Treatment:
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 group
Description:
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.
Treatment:
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 group
Description:
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
Treatment:
Drug: Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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