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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500004
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

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

Condition or disease Intervention/treatment Phase
Cachexia Neoplasms Pulmonary Disease, Chronic Obstructive Pancreatic Neoplasms 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Brown Adipose Tissue Activity and Energy Metabolism in Cachexia Induced by Cancer or Chronic Disease
Study Start Date : June 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cachectic pancreatic cancer

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.

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

Radiation: DXA scanning
Body composition: DXA scanning, D2O and MRI.

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

Procedure: Blood sampling
Systemic inflammatory profile: blood sampling.

Other: Indirect calorimetry
Resting metabolic rate: indirect calorimetry.

Device: Accelerometry
Physical activity level: accelerometry.

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

Active Comparator: Cachectic NSCLC

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.

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

Radiation: DXA scanning
Body composition: DXA scanning, D2O and MRI.

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

Procedure: Blood sampling
Systemic inflammatory profile: blood sampling.

Other: Indirect calorimetry
Resting metabolic rate: indirect calorimetry.

Device: Accelerometry
Physical activity level: accelerometry.

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

Active Comparator: Cachectic COPD

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.

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

Radiation: DXA scanning
Body composition: DXA scanning, D2O and MRI.

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

Procedure: Blood sampling
Systemic inflammatory profile: blood sampling.

Other: Indirect calorimetry
Resting metabolic rate: indirect calorimetry.

Device: Accelerometry
Physical activity level: accelerometry.

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

Active Comparator: Non-cachectic COPD

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.

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

Radiation: DXA scanning
Body composition: DXA scanning, D2O and MRI.

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

Procedure: Blood sampling
Systemic inflammatory profile: blood sampling.

Other: Indirect calorimetry
Resting metabolic rate: indirect calorimetry.

Device: Accelerometry
Physical activity level: accelerometry.

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

Healthy individuals

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.

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

Radiation: DXA scanning
Body composition: DXA scanning, D2O and MRI.

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

Procedure: Blood sampling
Systemic inflammatory profile: blood sampling.

Other: Indirect calorimetry
Resting metabolic rate: indirect calorimetry.

Device: Accelerometry
Physical activity level: accelerometry.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500004


Locations
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Netherlands
Maastricht UMC+
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Annemie Schols, PhD Maastricht UMC
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02500004    
Other Study ID Numbers: 142071
NL51402.068.14 ( Other Identifier: CCMO )
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: March 2016
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pulmonary Disease, Chronic Obstructive
Wasting Syndrome
Cachexia
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action