Trial Outcomes & Findings for Investigating Brown Adipose Tissue Activation in Humans (NCT NCT01935791)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

2hours

Results posted on

2021-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	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 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, 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 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 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 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 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 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 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 1 STARTED	4	4	3	0	0	0	0	0	0
Period 1 COMPLETED	4	4	3	0	0	0	0	0	0
Period 1 NOT COMPLETED	0	0	0	0	0	0	0	0	0
Period 2 STARTED	0	0	0	2	3	1	1	3	1
Period 2 COMPLETED	0	0	0	2	3	1	1	3	1
Period 2 NOT COMPLETED	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=11 Participants All participants who were randomised
Age, Continuous	26 years n=11 Participants
Sex: Female, Male Female	0 Participants n=11 Participants
Sex: Female, Male Male	11 Participants n=11 Participants
Region of Enrollment United Kingdom	11 Participants n=11 Participants
BMI	22.5 kg/m2 n=11 Participants

PRIMARY outcome

Timeframe: 2hours

Population: 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

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.

Outcome measures

Outcome measures
Measure	Period 1 Cold PET-CT Vehicle n=8 Participants Visit 1. emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine.	Period 1 Warm PET-CT Vehicle n=4 Participants 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 Warm PET(CT) Glucagon n=4 Participants 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.
Brown Adipose Tissue Activation Following Glucagon or Saline Infusion	0.074 MR[gluc] umol/kg/min Standard Deviation 0.007	0.010 MR[gluc] umol/kg/min Standard Deviation 0.003	0.029 MR[gluc] umol/kg/min Standard Deviation 0.008

PRIMARY outcome

Timeframe: 2hours

Population: Period 2 Crossover design

Period 2 Increase in energy expenditure measured using indirect calorimetry for Cold control vs Warm Control vs Warm Glucagon.