Metabolic Diseases
Conditions
Keywords
Metabolic Diseases
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.
Interventions
OTHERPeriod 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle
Temperature
DRUGPeriod 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon
Hormone
OTHERPeriod 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative
Temperature
DRUGPeriod 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control
Hormone
DRUGPeriod 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control
Hormone
DRUGPeriod 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon
hormone
DRUGPeriod 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control
hormone
DRUGPeriod 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control
hormone
DRUGPeriod 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon
Hormone
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants who were randomised | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 26 years | — |
| BMI | 22.5 kg/m2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 11 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 4 | 0 / 4 | 0 / 11 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 4 | 0 / 4 | 0 / 11 | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 4 | 0 / 4 | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
Primary
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.
Time frame: 2hours
Population: Period 1 Parallel design (3 out of 11 participants did not have BAT activation and therefore they were not included in the analysis).~Period 2 Crossover design
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Period 1 Cold PET-CT Vehicle | Brown Adipose Tissue Activation Following Glucagon or Saline Infusion | 0.074 MR[gluc] umol/kg/min | Standard Deviation 0.007 |
| Period 1 Warm PET-CT Vehicle | Brown Adipose Tissue Activation Following Glucagon or Saline Infusion | 0.010 MR[gluc] umol/kg/min | Standard Deviation 0.003 |
| Period 1 Warm PET(CT) Glucagon | Brown Adipose Tissue Activation Following Glucagon or Saline Infusion | 0.029 MR[gluc] umol/kg/min | Standard Deviation 0.008 |
p-value: <0.01ANOVA
Primary
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.
Time frame: 2hours
Population: Period 2 Crossover design
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Period 1 Cold PET-CT Vehicle | Increase in Energy Expenditure Following Glucagon or Saline Infusion | 193.0 increase in energy expenditure kcal/day | Standard Deviation 27.2 |
| Period 1 Warm PET-CT Vehicle | Increase in Energy Expenditure Following Glucagon or Saline Infusion | 41.1 increase in energy expenditure kcal/day | Standard Deviation 70 |
| Period 1 Warm PET(CT) Glucagon | Increase in Energy Expenditure Following Glucagon or Saline Infusion | 230.8 increase in energy expenditure kcal/day | Standard Deviation 30.1 |
p-value: <0.001ANOVA