Investigating Brown Adipose Tissue Activation in Humans

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

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

Official Title
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Investigating Brown Adipose Tissue Activation in Humans

Conditions
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Metabolic Diseases

Intervention / Treatment
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* 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
* 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 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control
* Drug: Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon
* 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 control, visit 2 cold control, visit 3 warm glucagon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle<br>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<br>* Temperature<br>|
| Experimental: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon<br>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<br>* Hormone<br>|
| Active Comparator: Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative<br>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<br>* Temperature<br>|
| Experimental: Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control<br>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<br>* Hormone<br>|
| Experimental: Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control<br>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<br>* Hormone<br>|
| Experimental: Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon<br>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<br>* hormone<br>|
| Experimental: Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control<br>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<br>* hormone<br>|
| Experimental: Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control<br>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<br>* hormone<br>|
| Experimental: Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon<br>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<br>* Hormone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Diseases