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

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Neoplasms; Pulmonary Disease, Chronic Obstructive; Cachexia; Pancreatic Neoplasms

Treatments: Radiation: 18F-FDG PET-MRI-imaging; Other: Double-labeled water; Procedure: Blood sampling; Device: Accelerometry; Radiation: DXA scanning; Other: Indirect calorimetry; Procedure: Abdominal subcutaneous adipose tissue biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02500004

NL51402.068.14 (Other Identifier)

142071

Details and patient eligibility

About

To study BAT activity and energy metabolism in patients with cachexia induced by cancer or chronic disease.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 5 patient groups

Cachectic pancreatic cancer

Active Comparator group

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.

Treatment:

Other: Indirect calorimetry

Procedure: Abdominal subcutaneous adipose tissue biopsy

Radiation: DXA scanning

Procedure: Blood sampling

Device: Accelerometry

Radiation: 18F-FDG PET-MRI-imaging

Other: Double-labeled water

Cachectic NSCLC

Active Comparator group

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.

Treatment:

Other: Indirect calorimetry

Procedure: Abdominal subcutaneous adipose tissue biopsy

Radiation: DXA scanning

Procedure: Blood sampling

Device: Accelerometry

Radiation: 18F-FDG PET-MRI-imaging

Other: Double-labeled water

Cachectic COPD

Active Comparator group

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.

Treatment:

Other: Indirect calorimetry

Procedure: Abdominal subcutaneous adipose tissue biopsy

Radiation: DXA scanning

Procedure: Blood sampling

Device: Accelerometry

Radiation: 18F-FDG PET-MRI-imaging

Other: Double-labeled water

Non-cachectic COPD

Active Comparator group

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.

Treatment:

Other: Indirect calorimetry

Procedure: Abdominal subcutaneous adipose tissue biopsy

Radiation: DXA scanning

Procedure: Blood sampling

Device: Accelerometry

Radiation: 18F-FDG PET-MRI-imaging

Other: Double-labeled water

Healthy individuals

Other group

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.

Treatment:

Other: Indirect calorimetry

Procedure: Abdominal subcutaneous adipose tissue biopsy

Radiation: DXA scanning

Procedure: Blood sampling

Device: Accelerometry

Radiation: 18F-FDG PET-MRI-imaging

Other: Double-labeled water