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Brown Adipose Tissue Activity and Energy Metabolism in Cachexia (BAT-Cachexia)

Primary Purpose

Cachexia, Neoplasms, Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
18F-FDG PET-MRI-imaging
DXA scanning
Abdominal subcutaneous adipose tissue biopsy
Blood sampling
Indirect calorimetry
Accelerometry
Double-labeled water
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cachexia

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Pancreatic cancer patients, or NSCLC cancer patients, or COPD patients
  • The diagnostic criterion for cachexia is unintentional weight loss more than 5% over the past 6 months or more than 2% in individuals with a body-mass index < 20 kg/m2 and muscle wasting assessed by DXA;
  • Age ≥ 30 years;
  • Gender: male and female;
  • Caucasians.

Exclusion Criteria:

  • Uncontrolled Diabetes Mellitus;
  • Patients with severe clotting disorder;
  • Patients with an active second malignancy;
  • Psychological unstable persons presumed unfit to perform the measurements, including claustrophobia;
  • Persons unable to lie or sit still for 1-2 hours;
  • Oxygen therapy;
  • Pregnant subjects;Subjects unable to undergo MRI (e.g. pacemaker; neurostimulator; implantable cardioverter-defibrillator (ICD) or leads; Foley bladder catheter; medication pump; cochlear or hearing implant; tattoos or other items that cannot be removed and include metal parts (for instance from operations in the past); metal splinter in the eye; vascular clips; denture, which contains magnets);
  • Subjects that received high doses of radiotherapeutic radiation of the neck and/or upper chest in their medical history;
  • Persons that received cervical or thoracic sympathectomy or have a nerve dysfunction which is likely to influence sympathetic nerves;
  • The use of medication that influences the sympathetic nerve system: ß-blockers, α-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic anti-depressives), reserpine, cocaine, calciumblockers, labetalol, and certain tranquillizers (fenothiazines).

Sites / Locations

  • Maastricht UMC+

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Other

Arm Label

Cachectic pancreatic cancer

Cachectic NSCLC

Cachectic COPD

Non-cachectic COPD

Healthy individuals

Arm Description

Cachectic patients with pancreatic cancer BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy. Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.

Cachectic patients with non-small cell lung cancer BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy. Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.

Cachectic COPD patients. BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy. Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.

Non-cachectic COPD patients. BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy. Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.

BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy. Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.

Outcomes

Primary Outcome Measures

Brown adipose tissue (BAT) activity measured by PET(-MRI)
The main endpoint of this study is BAT volume and intensity of activity in Standard Uptake Value (SUV) in the presence of cancer cachexia, COPD cachexia, and compared to non-cachectic COPD patients and healthy individuals, as assessed by 18F-fluoro-deoxyglucose (18F-FDG) PET-MRI scanning.

Secondary Outcome Measures

Total energy metabolism measured by resting energy expenditure (REE) and doubly labeled water
Resting metabolic rate measured by REE
Metabolic gene expression in WAT measured by biopsy of subcutaneous fat
Systemic inflammatory status measured in blood
Fat tissue mass measured by MRI, DXA, and doubly labeled water
Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA)
Hormonal status measured in blood
Lean tissue mass measured by MRI, DXA, and doubly labeled water
Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA)

Full Information

First Posted
June 24, 2015
Last Updated
August 1, 2018
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02500004
Brief Title
Brown Adipose Tissue Activity and Energy Metabolism in Cachexia
Acronym
BAT-Cachexia
Official Title
Brown Adipose Tissue Activity and Energy Metabolism in Cachexia Induced by Cancer or Chronic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To study BAT activity and energy metabolism in patients with cachexia induced by cancer or chronic disease.
Detailed Description
This is a prospective, cross-sectional study to determine BAT activity in cachectic patients with pancreatic or non-small cell lung cancer, and in cachectic patients with chronic obstructive pulmonary disease (COPD), and compare results with healthy individuals and non-cachectic COPD patients, matched for age and BMI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia, Neoplasms, Pulmonary Disease, Chronic Obstructive, Pancreatic Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cachectic pancreatic cancer
Arm Type
Active Comparator
Arm Description
Cachectic patients with pancreatic cancer BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy. Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.
Arm Title
Cachectic NSCLC
Arm Type
Active Comparator
Arm Description
Cachectic patients with non-small cell lung cancer BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy. Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.
Arm Title
Cachectic COPD
Arm Type
Active Comparator
Arm Description
Cachectic COPD patients. BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy. Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.
Arm Title
Non-cachectic COPD
Arm Type
Active Comparator
Arm Description
Non-cachectic COPD patients. BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy. Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.
Arm Title
Healthy individuals
Arm Type
Other
Arm Description
BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy. Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.
Intervention Type
Radiation
Intervention Name(s)
18F-FDG PET-MRI-imaging
Intervention Description
BAT activity: 18F-FDG PET-MRI-imaging.
Intervention Type
Radiation
Intervention Name(s)
DXA scanning
Intervention Description
Body composition: DXA scanning, D2O and MRI.
Intervention Type
Procedure
Intervention Name(s)
Abdominal subcutaneous adipose tissue biopsy
Intervention Description
Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.
Intervention Type
Procedure
Intervention Name(s)
Blood sampling
Intervention Description
Systemic inflammatory profile: blood sampling.
Intervention Type
Other
Intervention Name(s)
Indirect calorimetry
Intervention Description
Resting metabolic rate: indirect calorimetry.
Intervention Type
Device
Intervention Name(s)
Accelerometry
Intervention Description
Physical activity level: accelerometry.
Intervention Type
Other
Intervention Name(s)
Double-labeled water
Intervention Description
Body composition: DXA scanning, D2O and MRI. Total daily energy expenditure: double-labeled water.
Primary Outcome Measure Information:
Title
Brown adipose tissue (BAT) activity measured by PET(-MRI)
Description
The main endpoint of this study is BAT volume and intensity of activity in Standard Uptake Value (SUV) in the presence of cancer cachexia, COPD cachexia, and compared to non-cachectic COPD patients and healthy individuals, as assessed by 18F-fluoro-deoxyglucose (18F-FDG) PET-MRI scanning.
Time Frame
participants will be followed for 2 weeks
Secondary Outcome Measure Information:
Title
Total energy metabolism measured by resting energy expenditure (REE) and doubly labeled water
Time Frame
participants will be followed for 2 weeks
Title
Resting metabolic rate measured by REE
Time Frame
participants will be followed for 2 weeks
Title
Metabolic gene expression in WAT measured by biopsy of subcutaneous fat
Time Frame
participants will be followed for 2 weeks
Title
Systemic inflammatory status measured in blood
Time Frame
participants will be followed for 2 weeks
Title
Fat tissue mass measured by MRI, DXA, and doubly labeled water
Description
Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA)
Time Frame
participants will be followed for 2 weeks
Title
Hormonal status measured in blood
Time Frame
participants will be followed for 2 weeks
Title
Lean tissue mass measured by MRI, DXA, and doubly labeled water
Description
Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA)
Time Frame
participants will be followed for 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pancreatic cancer patients, or NSCLC cancer patients, or COPD patients The diagnostic criterion for cachexia is unintentional weight loss more than 5% over the past 6 months or more than 2% in individuals with a body-mass index < 20 kg/m2 and muscle wasting assessed by DXA; Age ≥ 30 years; Gender: male and female; Caucasians. Exclusion Criteria: Uncontrolled Diabetes Mellitus; Patients with severe clotting disorder; Patients with an active second malignancy; Psychological unstable persons presumed unfit to perform the measurements, including claustrophobia; Persons unable to lie or sit still for 1-2 hours; Oxygen therapy; Pregnant subjects;Subjects unable to undergo MRI (e.g. pacemaker; neurostimulator; implantable cardioverter-defibrillator (ICD) or leads; Foley bladder catheter; medication pump; cochlear or hearing implant; tattoos or other items that cannot be removed and include metal parts (for instance from operations in the past); metal splinter in the eye; vascular clips; denture, which contains magnets); Subjects that received high doses of radiotherapeutic radiation of the neck and/or upper chest in their medical history; Persons that received cervical or thoracic sympathectomy or have a nerve dysfunction which is likely to influence sympathetic nerves; The use of medication that influences the sympathetic nerve system: ß-blockers, α-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic anti-depressives), reserpine, cocaine, calciumblockers, labetalol, and certain tranquillizers (fenothiazines).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemie Schols, PhD
Organizational Affiliation
Maastricht UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht UMC+
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
33550302
Citation
Sanders K, Klooster K, Vanfleteren LEGW, Plasqui G, Dingemans AM, Slebos DJ, Schols AMWJ. Effect of Bronchoscopic Lung Volume Reduction in Advanced Emphysema on Energy Balance Regulation. Respiration. 2021 Feb 5:1-8. doi: 10.1159/000511920. Online ahead of print.
Results Reference
derived

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Brown Adipose Tissue Activity and Energy Metabolism in Cachexia

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