Brown Adipose Tissue Activity and Energy Metabolism in Cachexia

NCT ID: NCT02500004

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cachexia Neoplasms Pulmonary Disease, Chronic Obstructive Pancreatic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

18F-FDG PET-MRI-imaging

Intervention Type RADIATION

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

DXA scanning

Intervention Type RADIATION

Body composition: DXA scanning, D2O and MRI.

Abdominal subcutaneous adipose tissue biopsy

Intervention Type PROCEDURE

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

Blood sampling

Intervention Type PROCEDURE

Systemic inflammatory profile: blood sampling.

Indirect calorimetry

Intervention Type OTHER

Resting metabolic rate: indirect calorimetry.

Accelerometry

Intervention Type DEVICE

Physical activity level: accelerometry.

Double-labeled water

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

18F-FDG PET-MRI-imaging

Intervention Type RADIATION

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

DXA scanning

Intervention Type RADIATION

Body composition: DXA scanning, D2O and MRI.

Abdominal subcutaneous adipose tissue biopsy

Intervention Type PROCEDURE

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

Blood sampling

Intervention Type PROCEDURE

Systemic inflammatory profile: blood sampling.

Indirect calorimetry

Intervention Type OTHER

Resting metabolic rate: indirect calorimetry.

Accelerometry

Intervention Type DEVICE

Physical activity level: accelerometry.

Double-labeled water

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

18F-FDG PET-MRI-imaging

Intervention Type RADIATION

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

DXA scanning

Intervention Type RADIATION

Body composition: DXA scanning, D2O and MRI.

Abdominal subcutaneous adipose tissue biopsy

Intervention Type PROCEDURE

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

Blood sampling

Intervention Type PROCEDURE

Systemic inflammatory profile: blood sampling.

Indirect calorimetry

Intervention Type OTHER

Resting metabolic rate: indirect calorimetry.

Accelerometry

Intervention Type DEVICE

Physical activity level: accelerometry.

Double-labeled water

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

18F-FDG PET-MRI-imaging

Intervention Type RADIATION

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

DXA scanning

Intervention Type RADIATION

Body composition: DXA scanning, D2O and MRI.

Abdominal subcutaneous adipose tissue biopsy

Intervention Type PROCEDURE

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

Blood sampling

Intervention Type PROCEDURE

Systemic inflammatory profile: blood sampling.

Indirect calorimetry

Intervention Type OTHER

Resting metabolic rate: indirect calorimetry.

Accelerometry

Intervention Type DEVICE

Physical activity level: accelerometry.

Double-labeled water

Intervention Type OTHER

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.

Group Type OTHER

18F-FDG PET-MRI-imaging

Intervention Type RADIATION

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

DXA scanning

Intervention Type RADIATION

Body composition: DXA scanning, D2O and MRI.

Abdominal subcutaneous adipose tissue biopsy

Intervention Type PROCEDURE

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

Blood sampling

Intervention Type PROCEDURE

Systemic inflammatory profile: blood sampling.

Indirect calorimetry

Intervention Type OTHER

Resting metabolic rate: indirect calorimetry.

Accelerometry

Intervention Type DEVICE

Physical activity level: accelerometry.

Double-labeled water

Intervention Type OTHER

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

Interventions

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18F-FDG PET-MRI-imaging

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

Intervention Type RADIATION

DXA scanning

Body composition: DXA scanning, D2O and MRI.

Intervention Type RADIATION

Abdominal subcutaneous adipose tissue biopsy

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

Intervention Type PROCEDURE

Blood sampling

Systemic inflammatory profile: blood sampling.

Intervention Type PROCEDURE

Indirect calorimetry

Resting metabolic rate: indirect calorimetry.

Intervention Type OTHER

Accelerometry

Physical activity level: accelerometry.

Intervention Type DEVICE

Double-labeled water

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annemie Schols, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht UMC

Locations

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Maastricht UMC+

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 33550302 (View on PubMed)

Other Identifiers

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NL51402.068.14

Identifier Type: OTHER

Identifier Source: secondary_id

142071

Identifier Type: -

Identifier Source: org_study_id

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