CachexiaBAT-CachexiaNCT02500004
Brown Adipose Tissue Activity and Energy Metabolism in Cachexia
A study testing 18F-FDG PET-MRI-imaging, DXA scanning and Abdominal subcutaneous adipose tissue biopsy in people with Cachexia and Neoplasms, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
To study BAT activity and energy metabolism in patients with cachexia induced by cancer or chronic disease. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cachexia, Neoplasms, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- 18F-FDG PET-MRI-imaging, DXA scanning and Abdominal subcutaneous adipose tissue biopsy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brown Adipose Tissue Activity and Energy Metabolism in Cachexia Induced by Cancer or Chronic Disease
To study BAT activity and energy metabolism in patients with cachexia induced by cancer or chronic disease.
Read the 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.
- Being tested
- 18F-FDG PET-MRI-imaging, DXA scanning, Abdominal subcutaneous adipose tissue biopsy, Blood sampling, Indirect calorimetry
- Medical subject headings
- Cachexia, Neoplasms, Pulmonary Disease, Chronic Obstructive, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET-MRI-imagingRadiation
BAT activity: 18F-FDG PET-MRI-imaging.
DXA scanningRadiation
Body composition: DXA scanning, D2O and MRI.
Abdominal subcutaneous adipose tissue biopsyProcedure or surgery
Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.
Blood samplingProcedure or surgery
Systemic inflammatory profile: blood sampling.
Indirect calorimetryOther
Resting metabolic rate: indirect calorimetry.
AccelerometryDevice
Physical activity level: accelerometry.
Double-labeled waterOther
Body composition: DXA scanning, D2O and MRI. Total daily energy expenditure: double-labeled water.
| Study group | Role | What they receive |
|---|---|---|
| Cachectic pancreatic cancer | Active comparator | 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. Receives: Radiation: 18F-FDG PET-MRI-imaging; Radiation: DXA scanning; Procedure: Abdominal subcutaneous adipose tissue biopsy; Procedure: Blood sampling; Other: Indirect calorimetry; Device: Accelerometry; Other: Double-labeled water |
| Cachectic NSCLC | Active comparator | 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. Receives: Radiation: 18F-FDG PET-MRI-imaging; Radiation: DXA scanning; Procedure: Abdominal subcutaneous adipose tissue biopsy; Procedure: Blood sampling; Other: Indirect calorimetry; Device: Accelerometry; Other: Double-labeled water |
| Cachectic COPD | Active comparator | 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. Receives: Radiation: 18F-FDG PET-MRI-imaging; Radiation: DXA scanning; Procedure: Abdominal subcutaneous adipose tissue biopsy; Procedure: Blood sampling; Other: Indirect calorimetry; Device: Accelerometry; Other: Double-labeled water |
| Non-cachectic COPD | Active comparator | 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. Receives: Radiation: 18F-FDG PET-MRI-imaging; Radiation: DXA scanning; Procedure: Abdominal subcutaneous adipose tissue biopsy; Procedure: Blood sampling; Other: Indirect calorimetry; Device: Accelerometry; Other: Double-labeled water |
| Healthy individuals | Other | 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. Receives: Radiation: 18F-FDG PET-MRI-imaging; Radiation: DXA scanning; Procedure: Abdominal subcutaneous adipose tissue biopsy; Procedure: Blood sampling; Other: Indirect calorimetry; Device: Accelerometry; Other: Double-labeled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be followed for 2 weeks
Secondary outcomes (7)
Total energy metabolism measured by resting energy expenditure (REE) and doubly labeled water
Measured: participants will be followed for 2 weeks
Resting metabolic rate measured by REE
Measured: participants will be followed for 2 weeks
Metabolic gene expression in WAT measured by biopsy of subcutaneous fat
Measured: participants will be followed for 2 weeks
Systemic inflammatory status measured in blood
Measured: participants will be followed for 2 weeks
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)
Measured: participants will be followed for 2 weeks
Hormonal status measured in blood
Measured: participants will be followed for 2 weeks
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)
Measured: participants will be followed for 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annemie Schols, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500004
- Sponsor's protocol ID
- 142071
- Other IDs
- NL51402.068.14
- Acronym
- BAT-Cachexia
- Status last verified
- Mar 2016
- First submitted
- 24 Jun 2015
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33550302
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brown Adipose Tissue Activity and Energy Metabolism in Cachexia Induced by Cancer or Chronic Disease
- ClinicalTrials.gov ID
- NCT02500004
- Acronym / sponsor ID
- BAT-Cachexia / 142071
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cachectic pancreatic cancer | Active comparator | Radiation: 18F-FDG PET-MRI-imaging, Radiation: DXA scanning, Procedure: Abdominal subcutaneous adipose tissue biopsy, Procedure: Blood sampling, Other: Indirect calorimetry, Device: Accelerometry, Other: Double-labeled waterCachectic 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 NSCLC | Active comparator | Radiation: 18F-FDG PET-MRI-imaging, Radiation: DXA scanning, Procedure: Abdominal subcutaneous adipose tissue biopsy, Procedure: Blood sampling, Other: Indirect calorimetry, Device: Accelerometry, Other: Double-labeled waterCachectic 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 | Active comparator | Radiation: 18F-FDG PET-MRI-imaging, Radiation: DXA scanning, Procedure: Abdominal subcutaneous adipose tissue biopsy, Procedure: Blood sampling, Other: Indirect calorimetry, Device: Accelerometry, Other: Double-labeled waterCachectic 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 | Active comparator | Radiation: 18F-FDG PET-MRI-imaging, Radiation: DXA scanning, Procedure: Abdominal subcutaneous adipose tissue biopsy, Procedure: Blood sampling, Other: Indirect calorimetry, Device: Accelerometry, Other: Double-labeled waterNon-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. |
| Healthy individuals | Other | Radiation: 18F-FDG PET-MRI-imaging, Radiation: DXA scanning, Procedure: Abdominal subcutaneous adipose tissue biopsy, Procedure: Blood sampling, Other: Indirect calorimetry, Device: Accelerometry, Other: Double-labeled waterBAT 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG PET-MRI-imagingBAT activity: 18F-FDG PET-MRI-imaging. | Radiation | Cachectic COPD, Cachectic NSCLC, Cachectic pancreatic cancer, Healthy individuals, Non-cachectic COPD |
| DXA scanningBody composition: DXA scanning, D2O and MRI. | Radiation | Cachectic COPD, Cachectic NSCLC, Cachectic pancreatic cancer, Healthy individuals, Non-cachectic COPD |
| Abdominal subcutaneous adipose tissue biopsyInflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy. | Procedure or surgery | Cachectic COPD, Cachectic NSCLC, Cachectic pancreatic cancer, Healthy individuals, Non-cachectic COPD |
| Blood samplingSystemic inflammatory profile: blood sampling. | Procedure or surgery | Cachectic COPD, Cachectic NSCLC, Cachectic pancreatic cancer, Healthy individuals, Non-cachectic COPD |
| Indirect calorimetryResting metabolic rate: indirect calorimetry. | Other | Cachectic COPD, Cachectic NSCLC, Cachectic pancreatic cancer, Healthy individuals, Non-cachectic COPD |
| AccelerometryPhysical activity level: accelerometry. | Device | Cachectic COPD, Cachectic NSCLC, Cachectic pancreatic cancer, Healthy individuals, Non-cachectic COPD |
| Double-labeled waterBody composition: DXA scanning, D2O and MRI. Total daily energy expenditure: double-labeled water. | Other | Cachectic COPD, Cachectic NSCLC, Cachectic pancreatic cancer, Healthy individuals, Non-cachectic COPD |
Primary outcome
Brown adipose tissue (BAT) activity measured by PET(-MRI)
Time frame: participants will be followed for 2 weeks
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.
7 secondary outcomes
Total energy metabolism measured by resting energy expenditure (REE) and doubly labeled water
Time frame: participants will be followed for 2 weeks
Resting metabolic rate measured by REE
Time frame: participants will be followed for 2 weeks
Metabolic gene expression in WAT measured by biopsy of subcutaneous fat
Time frame: participants will be followed for 2 weeks
Systemic inflammatory status measured in blood
Time frame: participants will be followed for 2 weeks
Fat tissue mass measured by MRI, DXA, and doubly labeled water
Time frame: participants will be followed for 2 weeks
Hormonal status measured in blood
Time frame: participants will be followed for 2 weeks
Lean tissue mass measured by MRI, DXA, and doubly labeled water
Time frame: participants will be followed for 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Derived from this study: PubMed 33550302Sanders 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemie Schols, PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG PET-MRI-imaging, DXA scanning and Abdominal subcutaneous adipose tissue biopsy in people with Cachexia and Neoplasms, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brown adipose tissue (BAT) activity measured by PET(-MRI) (time frame: participants will be followed for 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02500004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.