Clinical trial NCT02500004: Brown Adipose Tissue Activity and Energy Metabolism in Cachexia
Official title: Brown Adipose Tissue Activity and Energy Metabolism in Cachexia Induced by Cancer or Chronic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cachexia
Neoplasms
Pulmonary Disease, Chronic Obstructive
Pancreatic Neoplasms
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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).

Primary outcomes:
measure: Brown adipose tissue (BAT) activity measured by PET(-MRI)
timeFrame: participants will be followed for 2 weeks
Secondary outcomes:
measure: Total energy metabolism measured by resting energy expenditure (REE) and doubly labeled water
timeFrame: participants will be followed for 2 weeks
measure: Resting metabolic rate measured by REE
timeFrame: participants will be followed for 2 weeks
measure: Metabolic gene expression in WAT measured by biopsy of subcutaneous fat
timeFrame: participants will be followed for 2 weeks
measure: Systemic inflammatory status measured in blood
timeFrame: participants will be followed for 2 weeks
measure: Fat tissue mass measured by MRI, DXA, and doubly labeled water
timeFrame: participants will be followed for 2 weeks
measure: Hormonal status measured in blood
timeFrame: participants will be followed for 2 weeks
measure: Lean tissue mass measured by MRI, DXA, and doubly labeled water
timeFrame: participants will be followed for 2 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
Study officials:
affiliation: Maastricht UMC
name: Annemie Schols, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.