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Brown adipose tissue activity and energy metabolism in cachexia induced by cancer or chronic disease

Completed
Conditions
'wasting syndrome' 'loss of lean body mass'
10000546
10017991
10029107
Registration Number
NL-OMON43922
Lead Sponsor
Medisch Universitair Ziekenhuis Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
70
Inclusion Criteria

Cachectic pancreatic cancer patients:
* Stage I-IV pancreatic cancer 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;

Cachectic NSCLC patients:
* Stage I-IV NSCLC 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;;Cachectic COPD patients:
* COPD GOLD I-IV (COPD patients with and without receiving lung volume reduction by endobronchial valves);
* 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;;Non-cachectic COPD patients:
* COPD GOLD I-IV (COPD patients with and without receiving lung volume reduction by endobronchial valves);
* Age * 30 years;
* Gender: male and female;;Healthy individuals:
* Age * 30 years;
* Gender: male and female;;Emphysematous COPD patients:
* Receiving lung volume reduction by endobronchial valves
* Age * 30 years;
* Gender: male and female;

Exclusion Criteria

Cachectic pancreatic cancer patients:
* 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; 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, *-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic anti-depressives), reserpine, cocaïne, calciumblockers, labetalol, and certain tranquillizers (fenothiazines).;Cachectic NSCLC patients:
* 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; 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, *-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic anti-depressives), reserpine, cocaïne, calciumblockers, labetalol, and certain tranquillizers (fenothiazines).;Cachectic COPD patients:
* 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; 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 w

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main endpoint of this study is BAT volume and intensity of activity in SUV<br /><br>in the presence of cancer cachexia, COPD cachexia, and compared to<br /><br>non-cachectic COPD patients and healthy individuals, as assessed by 18F-FDG<br /><br>PET-MRI scanning.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary endpoints are the relation of BAT activity to a) total energy<br /><br>metabolism and resting metabolic rate and b) metabolic gene expression in WAT<br /><br>and c) systemic inflammatory and hormonal status. Furthermore the PET-MRI<br /><br>allows detailed body composition phenotyping of cachexia to compare with<br /><br>commonly applied clinical measures (D2O and DEXA). Furthermore, dyspnea or<br /><br>meal-related oxygen desaturation, 6 minute walking test and heart rithm will be<br /><br>evaluated. </p><br>
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