Brown Adipose Tissue Activity and Energy Metabolism in Cachexia

NCT02500004 | Completed

• 2 other identifiers: 142071NL51402.068.14
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  participants will be followed for 2 weeks

Secondary Outcomes (7)

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

  participants will be followed for 2 weeks

• Resting metabolic rate measured by REE

  participants will be followed for 2 weeks

• Metabolic gene expression in WAT measured by biopsy of subcutaneous fat

  participants will be followed for 2 weeks

• Systemic inflammatory status measured in blood

  participants will be followed for 2 weeks

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

  participants will be followed for 2 weeks

Study Arms (5)

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.

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.

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.

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.

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.

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

Interventions

18F-FDG PET-MRI-imaging RADIATION

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

Cachectic COPD; Cachectic NSCLC; Cachectic pancreatic cancer; Healthy individuals; Non-cachectic COPD

DXA scanning RADIATION

Body composition: DXA scanning, D2O and MRI.

Cachectic COPD; Cachectic NSCLC; Cachectic pancreatic cancer; Healthy individuals; Non-cachectic COPD

Abdominal subcutaneous adipose tissue biopsy PROCEDURE

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

Cachectic COPD; Cachectic NSCLC; Cachectic pancreatic cancer; Healthy individuals; Non-cachectic COPD

Blood sampling PROCEDURE

Systemic inflammatory profile: blood sampling.

Cachectic COPD; Cachectic NSCLC; Cachectic pancreatic cancer; Healthy individuals; Non-cachectic COPD

Indirect calorimetry OTHER

Resting metabolic rate: indirect calorimetry.

Cachectic COPD; Cachectic NSCLC; Cachectic pancreatic cancer; Healthy individuals; Non-cachectic COPD

Accelerometry DEVICE

Physical activity level: accelerometry.

Cachectic COPD; Cachectic NSCLC; Cachectic pancreatic cancer; Healthy individuals; Non-cachectic COPD

Double-labeled water OTHER

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

Cachectic COPD; Cachectic NSCLC; Cachectic pancreatic cancer; Healthy individuals; Non-cachectic COPD

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC+

Maastricht, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 33550302 DERIVED

MeSH Terms

Conditions

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

Interventions

Blood Specimen Collection; Calorimetry, Indirect; Accelerometry

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Calorimetry; Chemistry Techniques, Analytical

Study Officials

• Annemie Schols, PhD

  Maastricht UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 16, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 3, 2018

Record last verified: 2016-03

Locations

NL (1)