Brown Adipose Tissue Activity and Energy Metabolism in Cachexia

Neoplasms Clinical Trial

— BAT-Cachexia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500004
• Other study ID #: 142071
• Secondary ID: NL51402.068.14
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: July 2018

Study information

• Verified date: March 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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, a-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic anti-depressives), reserpine, cocaine, calciumblockers, labetalol, and certain tranquillizers (fenothiazines).

Related Conditions & MeSH terms

• Cachexia
• Chronic Disease
• Lung Diseases
• Neoplasms
• Pancreatic Neoplasms
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastricht UMC+	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total energy metabolism measured by resting energy expenditure (REE) and doubly labeled water		participants will be followed for 2 weeks
Secondary	Resting metabolic rate measured by REE		participants will be followed for 2 weeks
Secondary	Metabolic gene expression in WAT measured by biopsy of subcutaneous fat		participants will be followed for 2 weeks
Secondary	Systemic inflammatory status measured in blood		participants will be followed for 2 weeks
Secondary	Fat tissue mass measured by MRI, DXA, and doubly labeled water	Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA)	participants will be followed for 2 weeks
Secondary	Hormonal status measured in blood		participants will be followed for 2 weeks
Secondary	Lean tissue mass measured by MRI, DXA, and doubly labeled water	Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA)	participants will be followed for 2 weeks