Understanding the relationship between blood pressure and catecholamine rhythms in health and in secretory paraganglioma/phaeochromocytoma Cancer
Conditions
Interventions
Conventional measurements of catecholamines in single-time point blood and 24-hour urine collections will be compared with 24-hour, 72-sample profiles collected using subcutaneous ambulatory microdial
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 2. Age >16 years 3. Clinical and radiological diagnosis of hormone-secreting phaeochromocytoma/paraganglioma 4. Healthy volunteers
Exclusion criteria
Exclusion criteria: 1. Inability to attend study visits due to location 2. Positive urine drug screen (drugs of abuse – cocaine, methamphetamines etc) as these will alter catecholamine measurements 3. History of intravenous drug use - any 4. Current pregnancy, breast feeding Patients: 5. Use of medication known to significantly interfere with measurement of metanephrines within 48 hours of or during the microdialysis sampling period Healthy volunteers: 6. Any active medical condition 7. Any regular prescribed medication 8. Use of any prescribed, over-the-counter, herbal or other medication within or during the 48 hours of microdialysis sampling period, or, at the investigator’s discretion, 9. Significant hypertension at screening (SBP >160/DBP >100) 10. Night shift work or international travel (more than 2 time zones) within the previous 60 days 11. Regular intake of alcohol well in excess of recommended weekly consumption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Concentrations of catecholamines and their metabolites in samples of microdialysate collected every 20 minutes for 24 hours 2. Concentrations of catecholamines and their metabolites in a venous plasma sample and in a 24 hour urine collection 3. Blood pressure measured using an automated ambulatory blood pressure cuff over 24 hours 4. Heart rate and heart rate variability measured using a portable ECG monitor over 24 hours 5. Peripheral temperature measurements collected every 1 minute using a skin thermometer (iButton) for 24 hours 6. Food intake using a self-reported food diary for 24 hours 7. Sleep and wake patterns and light exposure from a self-reported sleep diary and calculated from wrist actigraphy and light monitoring data for 8 days 8. Blood glucose estimates derived from measurements collected using an interstitial continuous glucose monitor (CGM), sampled every 15 minutes for 8 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Catecholamine features (area under the curve, peak concentrations, peak and nadir times etc) measured as per primary outcome measure 1 | — |
Countries
England, Greece, United Kingdom
Outcome results
None listed