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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43922
Enrollment
70
Registered
2015-03-19
Start date
2015-07-15
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

'wasting syndrome' 'loss of lean body mass'

Interventions

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 infl

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The main endpoint of this study is BAT volume and intensity of activity in SUV in the presence of cancer cachexia, COPD cachexia, and compared to non-cachectic COPD patients and healthy individuals, as assessed by 18F-FDG PET-MRI scanning.

Secondary

MeasureTime frame
Secondary endpoints are the relation of BAT activity to a) total energy metabolism and resting metabolic rate and b) metabolic gene expression in WAT and c) systemic inflammatory and hormonal status. Furthermore the PET-MRI allows detailed body composition phenotyping of cachexia to compare with commonly applied clinical measures (D2O and DEXA). Furthermore, dyspnea or meal-related oxygen desaturation, 6 minute walking test and heart rithm will be evaluated.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)