An observational study in Adrenal Insufficiency, Congenital Adrenal Hyperplasia and Cushing Syndrome, sponsored by Haukeland University Hospital. Completed at 4 sites in 4 countries. Open to participants aged 18 Years to 68 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-15.
Sponsored by Haukeland University Hospital · Observational
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.
136 studies on the registry are indexed under Adrenal Insufficiency; 27 are open to participants now.
This study's enrollment of 528 is above the median of 85 across 59 observational studies indexed under Adrenal Insufficiency.
Browse Adrenal Insufficiency studies →Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
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Healthy Controls and patients with established Cushing syndrome, Adrenal Insufficiency, Congenital adrenal hyperplasia, Primary hyperaldosteronism, Acromegaly and Growth hormone deficiency
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Definition of the normal circadian and ultradian profiles of pituitary and adrenal hormones in healthy subjects:Each subject (total number 200, anticipated 50 per study centre) will be sampled by the ULTRADIAN sampling device for 27 hours. Day to day hormonal variability:A subgroup of 20 subjects will be asked to undergo sampling on three occasions to assess reproducibility of hormonal levels over time. Comparison of tissue and blood concentrations of hormones: 20 subjects will be asked to participate in the study comparing hormonal tissue level and blood levels.
Other: 27 hour subcutaneous fluid sampling
Diagnosis of Cushing's syndrome by ULTRADIAN dynamic cortisol measurements The primary objective is to establish circadian and ultradian hormonal profiles of patients with Cushing's from 24 hour ambulatory sampling of subcutaneous fluid. A secondary aim is to compare the pre and post-operative hormonal profiles of patients with Cushings and to compare these results to age/sex matched control Study subjects: Subjects with established clinical and biochemical Cushing's syndrome (ACTH-producing pituitary adenoma or ACTH-independent adrenal source).
Other: 27 hour subcutaneous fluid sampling
Monitoring of adrenal insufficiency (AI) by ULTRADIAN dynamic cortisol and ACTH measurements Aims and objectives: to compare hormonal profiles of patients with Adrenal insufficiency on conventional replacement regimes to age/sex matched controls. Study subjects: Subjects with established primary (adrenal) AI
Other: 27 hour subcutaneous fluid sampling
Monitoring of congenital adrenal hyperplasia (CAH) by ULTRADIAN dynamic cortisol, ACTH, and androgen measurements Aims and objectives: to compare hormonal profiles of patients with CAH on conventional replacement regimes to age/sex matched controls. Study subjects: Individuals with established CAH either salt- wasting or simple virilisation forms on glucocorticoid replacement therapy
Other: 27 hour subcutaneous fluid sampling
Diagnosis of primary hyperaldosteronism (PHA) by ULTRADIAN dynamic aldosterone and renin measurements Aims and objectives: The primary objective is to establish circadian and ultradian profiling of free aldosterone and renin in subcutaneous tissue. Secondary objectives are (1) to compare pre and post-operative profiles (2) to identify profiles typical for adenoma as opposed to bilateral hyperplasia and (3) to compare profiles to age/sex matched controls. Study subjects: Subjects with suspected PHA.
Other: 27 hour subcutaneous fluid sampling
Diagnosis of growth hormone deficiency (GHD) by ULTRADIAN dynamic growth hormone measurements Aims and objectives: The primary objective is to establish hormonal circadian and ultradian profiles of adult GHD by analysing the growth hormone profile in the subcutaneous tissue fluid. Study subjects: Adult subjects with established clinical and biochemical GHD.
Other: 27 hour subcutaneous fluid sampling
Diagnosis and treatment of acromegaly by ULTRADIAN dynamic growth hormone measurements Aims and objectives: The primary objective is to establish hormonal profiles of patients with Acromegaly A secondary objective is to compare pre and post-operative profiles and to compare these profiles to age/sex matched controls. Study subjects: Patients with established clinical and biochemical Acromegaly by current diagnostic criteria
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).
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
Plan to share: No
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