Dynamic Hormone Diagnostics in Endocrine Disease
Condition: Adrenal Insufficiency; Congenital Adrenal Hyperplasia; Cushing Syndrome; Growth Hormone Deficiency; Acromegaly; Primary Hyperaldosteronism
MeSH terms: Acromegaly; Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenal Insufficiency; Cushing Syndrome; Hyperaldosteronism; Hyperplasia
Study type: Observational

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.
    

Intervention name(s): 27 hour subcutaneous fluid sampling
Intervention type(s): Other
Intervention description(s): 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).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy Controls and patients with established Cushing syndrome, Adrenal Insufficiency,
        Congenital adrenal hyperplasia, Primary hyperaldosteronism, Acromegaly and Growth hormone
        deficiency
      
Biospecimen description: 
      Subcutaneous fluid/dialysate, saliva samples, urine samples and blood samples
    
Keywords: dynamic hormone diagnostics; adrenal insufficiency; congenital adrenal hyperplasia; primary hyperaldosteronism; cushing syndrome; growth hormone deficiency; acromegaly