An interventional study of Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle and Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon in Metabolic Diseases, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by Imperial College London · Not applicable, Interventional, and Basic science
The purpose of this study is to determine what can activate brown adipose tissue (BAT).
We will investigate different stimuli (i.e. hormones) to determine which can stimulate BAT.
997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.
This study's enrollment of 11 is below the median of 48 across 670 interventional studies indexed under Metabolic Diseases.
Browse Metabolic Diseases studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: 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 Glucagon at a dose of 50ng/kg/min without a cooling vest.
Drug: 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. No brown adipose tissue (BAT) identified on visit 1, therefore no visit 2.
Other: Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative
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.
Drug: 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 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.
Drug: 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 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.
Drug: 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 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.
Drug: 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 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.
Drug: 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 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
Drug: Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon
Temperature
Hormone
Temperature
Hormone
Hormone
hormone
hormone
hormone
Hormone
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.
Time frame: 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.
Time frame: 2hours
| Milestone | 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 | 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 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 4 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 4 | 4 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | 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 | 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 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 2 | 3 | 1 | 1 | 3 | 1 |
| Completed | 0 | 0 | 0 | 2 | 3 | 1 | 1 | 3 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| MR[gluc] umol/kg/min | Period 1 Cold PET-CT Vehicle | Period 1 Warm PET-CT Vehicle | Period 1 Warm PET(CT) Glucagon |
|---|---|---|---|
| Brown Adipose Tissue Activation Following Glucagon or Saline Infusion | 0.074 ± 0.007 | 0.010 ± 0.003 | 0.029 ± 0.008 |
Period 2 Increase in energy expenditure measured using indirect calorimetry for Cold control vs Warm Control vs Warm Glucagon.
| increase in energy expenditure kcal/day | Period 2 - Cold Control | Period 2 - Warm Control | Period 2 -Warm Glucagon |
|---|---|---|---|
| Increase in Energy Expenditure Following Glucagon or Saline Infusion | 193.0 ± 27.2 | 41.1 ± 70 | 230.8 ± 30.1 |
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Period 1 Visit 1 Cold Vehicle | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Period 1 Visit 2 Warm Glucagon | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Period 1 Visit 2 Warm Vehicle | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Period 2 Cold Control | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Period 2 Warm Control | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Period 2 Warm Glucagon | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 26 (20 to 40) |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 0 |
| Male | 11 |
| Race and Ethnicity Not Collected(Participants) | All Participants |
|---|
| Region of Enrollment(Participants) | All Participants |
|---|---|
| United Kingdom | 11 |
| BMI(kg/m2) | All Participants |
|---|---|
| Mean | 22.5 (20.5 to 25.2) |
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Imperial College London