NCT02934399

Dynamic Hormone Diagnostics in Endocrine Disease

Dynamic Hormone Diagnostics (Ultradian)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 528 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Adrenal Insufficiency
• Congenital Adrenal Hyperplasia
• Cushing Syndrome
• Growth Hormone Deficiency
• Acromegaly
• Primary Hyperaldosteronism

Interventions

Type	Name	Description
OTHER	27 hour subcutaneous fluid sampling	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).

Timeline

• Start date: 2016-10-01
• Primary completion: 2023-11-14
• Completion: 2023-11-14
• First posted: 2016-10-17
• Last updated: 2023-11-15

Locations

4 sites across 4 countries: Greece, Norway, Sweden, United Kingdom