Hypercortisolism, Mineralocorticoid Excess, Primary Aldosteronism
Conditions
Keywords
aldosterone
Brief summary
This study is a observational study applying 24-hour microdialysis methodology to perform dynamic multisteroid adrenal hormone profiling of patients with suspected or confirmed PA. Simultaneous registration of blood pressure, tissue glucose, sleep pattern, activity level and food intake registration may be performed. The overall objective is to develop a novel, sensitive, fast and user-friendly diagnostic procedure for PA, using multimodal data capture including dynamic multisteroid hormone profiling from microdialysis fluid.
Detailed description
Primary aldosteronism is the most common cause of secondary hypertension. Primary aldosteronism has increased risk of organ complications compared with primary hypertension if left undiagnosed and without specific treatment. However, the current diagnostic work-up is a cumbersome, multistep process, relying on repeated single time point measurements of aldosterone, not capturing the rhythmic nature of aldosterone and related adrenal hormone secretion. In this study we will apply the U-Rhythm microdialysis sampling system for 24-hour measurements from subcutaneous microdialysis fluid, analysed with LC/MS-MS methodology for dynamic multisteroid adrenal hormone profiling. We will further compare multisteroid hormone profiling results with variations in blood pressure and tissue glucose, sleep pattern, activity level and food intake. The overall objective of the study is to develop a novel, sensitive, fast and user-friendly diagnostic procedure for PA, using multimodal data capture including 24-hour dynamic multisteroid hormone profiling from microdialysis tissue. Primary objective • Assess dynamic multisteroid rhythmicity in microdialysis fluid of aldosterone, precursors and metabolites of the mineralocorticoid and glucocorticoid pathway, compared to standard diagnostic work-up in patients with suspected or confirmed PA. Secondary objectives * Quantify the influence of salt and volume loading during diagnostic saline infusion test on multisteroid adrenal rhythmicity. * Quantify the influence of glucocorticoids/ACTH suppression on multisteroid rhythmicity. * Quantify the influence of cortisol co-secretion on multisteroid rhythmicity in PA. * Quantify influence of blood pressure, pulse, sleep, food intake and movement on multisteroid rhythmicity in PA.
Interventions
DEVICEdynamic microdialysis sampling
Included patients will perform 24-hour dynamic microdialysis sampling from subcutaneous tissue fluid of the lower abdomen, applying the U-Rhythm sampler. Simutaneous measurements of blood pressure, glucose, and registration of activity level, meals and sleep pattern during microdialysis sampling may be performed. Microdialysis sampling will be performed during various conditions: during daily life activities, during saline infusion suppression testing and during dexamethasone suppression testing. Repeated sampling may be performed post treatment.
Sponsors
University of Bergen
Haukeland University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Inclusion criteria
Age 18 to 70 years Suspected PA admitted for diagnostic saline infusion testing or confirmed PA diagnosis according to Endocrine Society criteria.. Written informed consent
Exclusion criteria
* Age \<18 or \> 70 years. * Pregnancy. * Known adrenal failure and/or on steroid therapy (oral, inhaled, parenteral or topical) or other interfering medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multisteroid rhythmicity of mineralocorticoids and glucocorticoids in primary aldosteronism | 2024-2028 | Assess multisteroid rhythmicity measured in microdialysis fluid of aldosterone, precursors and metabolites of the mineralocorticoid and glucocorticoid pathway, compared to standard diagnostic work-up in patients with suspected or confirmed PA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of saline infusion test on multisteroid rhythmicity of mineralocorticoids and glucocorticoids | 2024-2028 | Influence of diagnostic saline infusion test on multisteroid adrenal rhythmicity will be assessed by performing 24h microdialysis before and during saling infusion testing |
| Effect of exogenous glucocorticoid suppression on aldosterone rhythmicity | 2024-2028 | Influence of exogenous administered glucocorticoids on aldosterone and related adrenal hormone rhythmicity will be assessed by performing 24h microdilays without and during suppression with exogenous glucocorticoids |
| cortisol co-secretion in primary aldosteronism | 2024-2028 | determine and quantify the presence of cortisol co-secretion in primary aldosteronism assessed by dynamic microdialysis compared with conventional cortisol co-secretion testing |
| Blood pressure, glucose and sleeep pattern correlation to dynamic hormone rhythmicity in primary aldosteronism | 2024-2028 | Correlate continous blood pressure and glucose variations, sleep, food intake and movement to variations in multisteroid hormone rhythmicity in primary aldosteronism. |
Countries
Norway
Contacts
Primary ContactMarianne Aardal Grytaas, MD PhD
Backup ContactKristian Løvås, MD PhD
Outcome results
None listed