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Clinical Trials/NCT01935791
NCT01935791
Completed
Not Applicable

Investigating Brown Adipose Tissue Activation in Humans

Imperial College London1 site in 1 country11 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle
Conditions
Metabolic Diseases
Sponsor
Imperial College London
Enrollment
11
Locations
1
Primary Endpoint
Brown Adipose Tissue Activation Following Glucagon or Saline Infusion
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
November 5, 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: 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

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.

Intervention: 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

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.

Intervention: 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

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.

Intervention: 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

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.

Intervention: 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

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.

Intervention: 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

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.

Intervention: 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

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.

Intervention: 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

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

Intervention: Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon

Outcomes

Primary Outcomes

Brown Adipose Tissue Activation Following Glucagon or Saline Infusion

Time Frame: 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

Time Frame: 2hours

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

Study Sites (1)

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