Investigating Brown Adipose Tissue Activation in Humans

Not Applicable

Completed

• Conditions: Metabolic Diseases
• Interventions: Drug: Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon; Other: Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative; Other: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle; Drug: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon; Drug: Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control; Drug: Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control; Drug: Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control; Drug: Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon; Drug: Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control

• Registration Number: NCT01935791
• Lead Sponsor: Imperial College London

Brief Summary

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

Detailed Description

We will investigate different stimuli (i.e. hormones) to determine which can stimulate BAT.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-05
• Primary Completion: 2018-11-05
• Study Completion: 2018-11-05
• Results First Submitted: 2019-06-06
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-17
• Last Update Submitted: 2021-05-17
• Results First Posted: 2021-05-18
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• aged >18 years

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon	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 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative	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, Visit 2 -Warm PET-CT Vehicle	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	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 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control	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	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 glucagon, visit 3 warm control	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 control, visit 2 cold control, visit 3 warm glucagon	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 glucagon, visit 2 warm control, visit 3 cold control	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.

Primary Outcome Measures

Name	Time	Method
Brown Adipose Tissue Activation Following Glucagon or Saline Infusion	2hours	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	2hours	Period 2 Increase in energy expenditure measured using indirect calorimetry for Cold control vs Warm Control vs Warm Glucagon.

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom