Investigating Brown Adipose Tissue Activation in Humans

NCT ID: NCT01935791

Last Updated: 2021-05-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2018-11-05

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.

Conditions

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Metabolic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle

Intervention Type OTHER

Temperature

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.

Group Type EXPERIMENTAL

Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon

Intervention Type DRUG

Hormone

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.

Group Type ACTIVE_COMPARATOR

Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative

Intervention Type OTHER

Temperature

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.

Group Type EXPERIMENTAL

Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control

Intervention Type DRUG

Hormone

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.

Group Type EXPERIMENTAL

Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control

Intervention Type DRUG

Hormone

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

hormone

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

hormone

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

hormone

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Hormone

Interventions

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Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle

Temperature

Intervention Type OTHER

Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon

Hormone

Intervention Type DRUG

Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative

Temperature

Intervention Type OTHER

Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control

Hormone

Intervention Type DRUG

Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control

Hormone

Intervention Type DRUG

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

hormone

Intervention Type DRUG

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

hormone

Intervention Type DRUG

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

hormone

Intervention Type DRUG

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

Hormone

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Waljit Dhillo

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Salem V, Izzi-Engbeaya C, Coello C, Thomas DB, Chambers ES, Comninos AN, Buckley A, Win Z, Al-Nahhas A, Rabiner EA, Gunn RN, Budge H, Symonds ME, Bloom SR, Tan TM, Dhillo WS. Glucagon increases energy expenditure independently of brown adipose tissue activation in humans. Diabetes Obes Metab. 2016 Jan;18(1):72-81. doi: 10.1111/dom.12585. Epub 2015 Nov 20.

Reference Type RESULT
PMID: 26434748 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://jnm.snmjournals.org/content/59/3/516.long

Thermal Imaging Is a Noninvasive Alternative to PET/CT for Measurement of Brown Adipose Tissue Activity in Humans

Other Identifiers

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13HH0688

Identifier Type: -

Identifier Source: org_study_id

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