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Completed

NCT Number: NCT02500004

Brown Adipose Tissue Activity and Energy Metabolism in Cachexia

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

18F-FDG PET-MRI-imaging

Radiation

BAT activity: 18F-FDG PET-MRI-imaging.

DXA scanning

Radiation

Body composition: DXA scanning, D2O and MRI.

Abdominal subcutaneous adipose tissue biopsy

Procedure

Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.

blood sampling

Procedure

Systemic inflammatory profile: blood sampling.

Indirect Calorimetry

Other

Resting metabolic rate: indirect calorimetry.

Accelerometry

Device

Physical activity level: accelerometry.

Double-labeled water

Other

Body composition: DXA scanning, D2O and MRI. Total daily energy expenditure: double-labeled water.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total energy metabolism measured by resting energy expenditure (REE) and doubly labeled water

    Time frame: participants will be followed for 2 weeks

  2. Resting metabolic rate measured by REE

    Time frame: participants will be followed for 2 weeks

  3. Metabolic gene expression in WAT measured by biopsy of subcutaneous fat

    Time frame: participants will be followed for 2 weeks

  4. Systemic inflammatory status measured in blood

    Time frame: participants will be followed for 2 weeks

  5. Fat tissue mass measured by MRI, DXA, and doubly labeled water

    Time frame: participants will be followed for 2 weeks

    Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA)

  6. Hormonal status measured in blood

    Time frame: participants will be followed for 2 weeks

  7. Lean tissue mass measured by MRI, DXA, and doubly labeled water

    Time frame: participants will be followed for 2 weeks

    Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA)

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Brown Adipose Tissue Activity and Energy Metabolism in Cachexia Induced by Cancer or Chronic Disease

Acronym: BAT-Cachexia

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 16, 2015
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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