The study will investigate 27 hour profiles of hormones in the subcutaneous tissue of healthy subjects and patients with Addison's, Congenital Adrenal Hyperplasia, Growth Hormone Deficiency, acromegaly, Cushings and Primary Hyperaldosteronism during conventional diagnostic and therapeutic follow-up. The 27 hour monitoring by ULTRADIAN takes into account the rhythm of hormones throughout the day. It is hoped that this information may in the future improve and simplify diagnostic procedures. Follow-up of patients in endocrinology still remains difficult including clinical signs of over and under-treatment, questionnaires of quality of life and blood testing necessitating often retesting. Simplification of the diagnostic procedure by obtaining detailed knowledge about the rhythm of hormones may contribute to the improvement and individualization of treatment and may decrease morbidity and mortality of endocrine patients.
Microdialysis fluid will be collected from all participants using the ULTRADIAN dynamic diagnostics system. This is a 3-component collection system which can easily be attached to a belt and allows participants to continue with their normal everyday activities whilst undergoing sampling. The micro-fractions are minute, the volume would normally be by far too small to use with current immunoassays. ULTRADIAN will overcome this hurdle by introducing two novel techniques; ultrasensitive liquid chromatography tandem mass spectroscopy (LCMS/MS) for steroid hormones, and the proximity extension assay (PEA®), which allows the simultaneous assay of up to 96 analytes in only 1 µL fluid. The microdialysis sampling will be performed in addition to the conventional diagnostic sampling, and during normal follow-up of patients.
Study Type
OBSERVATIONAL
Enrollment
528
One hour prior to the microdialysis catheter insertion the participants will be asked to receive a local anaesthetic on the injection site for the microdialysis catheter. Lignocaine 1% will be injected subcutaneously at a localised site on the abdomen covering a horizontal area of about 5cm after a brief acclimatisation period at the hospital. A sterile linear catheter will be inserted using aseptic precautions at the anaesthetised site on the abdomen. The catheter is connected at one end to the microdialysis pump, and at the other end to the automated collection device. Subcutaneous tissue microdialysis samples will be collected regularly for the duration of the sampling period (27 hours).
Evangelissmos hospital
Athens, Greece
Haukeland University Hospital
Bergen, Norway
Karolinska Institutet
Stockholm, Sweden
Bristol University hospital
Bristol, United Kingdom
steroids
Physiological hormonal curve by sampling of 27h subcutaneous fluid to measure steroids
Time frame: 27 hours
androgens
Physiological hormonal by sampling of 27h subcutaneous fluid to measure androgens
Time frame: 27 hours
mineralocorticoids
Physiological hormonal curve by sampling of 27h subcutaneous fluid to measure mineralocorticoids
Time frame: 27 hours
ACTH
Physiological hormonal curve by sampling of 27h subcutaneous fluid to measure ACTH
Time frame: 27 hours
growth hormone
Physiological hormonal curve by sampling of 27h subcutaneous fluid to measure growth hormone
Time frame: 27 hours
steroids in Addison disease
Hormonal curve by sampling of 27h subcutaneous fluid to measure steroids
Time frame: 27 hours
steroids in congenital adrenal hyperplasia
Hormonal curve by sampling of 27h subcutaneous fluid to measure steroids
Time frame: 27 hours
androgen in congenital adrenal hyperplasia
Hormonal curve by sampling of 27h subcutaneous fluid to measure androgens
Time frame: 27 hours
growth hormone in acromegaly
Hormonal curve by sampling of 27h subcutaneous fluid to measure growth hormone
Time frame: 27 hours
growth hormone in growth hormone deficiency
Hormonal curve by sampling of 27h subcutaneous fluid to measure growth hormone
Time frame: 27 hours
mineralocorticoids in primary hyperaldosteronism
Hormonal curve by sampling of 27h subcutaneous fluid to measure mineralocorticoids
Time frame: 27 hours
Intra-individual variability and the accuracy of steroids hormones
comparison of steroids levels in repetitive testing
Time frame: 27 hours
Intra-individual variability and the accuracy of androgens
comparison of androgens levels in repetitive testing
Time frame: 27 hours
Intra-individual variability and the accuracy of mineralocorticoids
comparison of mineralocorticoids levels in retesting by microdialysis
Time frame: 27 hours
Intra-individual variability and the accuracy of growth hormone
comparison of growth hormone levels in retesting by microdialysis
Time frame: 27 hours
Intra-individual variability and the accuracy of ACTH
comparison of ACTH levels in retesting by microdialysis
Time frame: 27 hours
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