Trial · Interventional

CompletedNot applicableResults postedRegistry data

Investigating Brown Adipose Tissue Activation in Humans

NCTNCT01935791Other id13HH0688

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 11 participants (actual)
Sponsor: Imperial College London · Other
Design: Randomized · Single masking
Countries: 1 country
United Kingdom
Start: Jul 2013
Primary completion: 5 Nov 2018
Completion: 5 Nov 2018
First posted: 5 Sept 2013 (estimated)
Last update posted: 18 May 2021
Conditions: Metabolic Diseases

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2013201420152016201720182019

N/A
Investigating Brown Adipose Tissue Activation in Humans
NCT01935791
Jul 2013 to 5 Nov 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine what can activate brown adipose tissue (BAT).

Interventions

Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT VehicleOther
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT GlucagonDrug
Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negativeOther
Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold controlDrug
Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm controlDrug
Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagonDrug
Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm controlDrug
Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold controlDrug
Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagonDrug

Arms9

Active comparator
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.
Experimental
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.
Active comparator
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.
Experimental
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.
Experimental
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.
Experimental
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.
Experimental
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.
Experimental
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.
Experimental
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

Primary outcomes2

Outcomes the sponsor listed as primary.

Brown Adipose Tissue Activation Following Glucagon or Saline Infusion
Time frame · 2hours
Registry description
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.
Increase in Energy Expenditure Following Glucagon or Saline Infusion
Time frame · 2hours
Registry description
Period 2 Increase in energy expenditure measured using indirect calorimetry for Cold control vs Warm Control vs Warm Glucagon.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 2hours

Brown Adipose Tissue Activation Following Glucagon or Saline Infusion

Group	Value (MR[gluc] umol/kg/min)	Spread
Period 1 Cold PET-CT Vehicle	0.074	0.007
Period 1 Warm PET-CT Vehicle	0.010	0.003
Period 1 Warm PET(CT) Glucagon	0.029	0.008

Primary outcomeMean· 2hours

Increase in Energy Expenditure Following Glucagon or Saline Infusion

Group	Value (increase in energy expenditure kcal/day)	Spread
Period 2 - Cold Control	193.0	27.2
Period 2 - Warm Control	41.1	70
Period 2 -Warm Glucagon	230.8	30.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Period 1 Visit 1 Cold VehicleParticipants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine.	0 / 11	0 / 11	0 / 11
Period 1 Visit 2 Warm GlucagonParticipants 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.	0 / 4	0 / 4	0 / 4
Period 1 Visit 2 Warm VehicleParticipants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst receiving an infusion of gelofusine without a cooling vest.	0 / 4	0 / 4	0 / 4
Period 2 Cold ControlEach participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest.	0 / 11	0 / 11	0 / 11
Period 2 Warm ControlEach 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.	0 / 11	0 / 11	0 / 11
Period 2 Warm GlucagonEach 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.	0 / 11	0 / 11	0 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2016

4 results

Glucagon increases energy expenditure independently of brown adipose tissue activation in humans.

Salem et al. 2016Diabetes, obesity & metabolismcited by 152

PMID 26434748PMC4710848DOI 10.1111/dom.12585PUB-26434748

CC BY4 results

Download PDF See results (4)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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