Clinical trial NCT03505775: Evaluation of the Muscular and Cutaneous Sodium Storage by 23Na MRI in Patients With Chronic Adrenal Insufficiency
Official title: Evaluation of the Muscular and Cutaneous Sodium Storage by 23Na Magnetic Resonance Imaging in Patients With Chronic Adrenal Insufficiency Compared to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adrenal Insufficiency
Keywords: Hormone replacement
Mineralocorticoids
23Na-magnetic resonance imaging
Tissue sodium content
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study investigates the sodium content in the calf muscle and the skin obtained via 23Na-magnetic resonance imaging in patients with chronic adrenal insufficiency compared to healthy controls.

Detailed description: Patients with chronic adrenal insufficiency depend on lifelong glucocorticoid and mineralocorticoid replacement therapy. Monitoring is based on clinical and laboratory parameters reflecting hemodynamic stability, electrolyte status and plasma renin concentration. Reduced subjective well-being is however often described by these patients in absence of clinical or laboratory abnormalities and is thus a strong indicator of the gap between the concept of adequate hormone substitution and patients' requirements. This study investigates the sodium content in the calf muscle and the skin obtained via 23Na-magnetic resonance imaging (MRI) in patients with chronic adrenal insufficiency compared to age-, sex- and BMI- matched healthy controls. The aim of the study is to evaluate the potential role of 23Na-MRI for monitoring of hormone replacement by investigating tissue sodium concentrations in patients with adrenal insufficiency.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Written informed consent
* Chronic adrenal insufficiency (first diagnosis \> 6months), stable hormone replacement therapy with glucocorticoids (no dose-adjustment \>50mg hydrocortisone within the last 8 weeks) and mineralocorticoids (only primary adrenal insufficiency)! Or healthy control (no adrenal insufficiency, normal serum-electrolytes, normotensive blood pressure, no medication with a known influence on the electrolyte balance)!

Exclusion Criteria:

* Pregnancy or breast-feeding
* Metal-implant (not MRI-compatible)
* Claustrophobia
* Chronic internistic disease (hypertension, heart failure, liver cirrhosis)
* Polydipsia (\>4l/d)
* Long-term medication that can cause a hyponatraemia (for example diuretics)

Primary outcomes:
measure: Muscle sodium content
timeFrame: 6 months
measure: Skin sodium content
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Hospital Wuerzburg, Dept. of medicine I
Study officials:
affiliation: University Hospital Wuerzburg, Dept. of medicine I, Germany
name: Stefanie Hahner, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hahner S, Loeffler M, Fassnacht M, Weismann D, Koschker AC, Quinkler M, Decker O, Arlt W, Allolio B. Impaired subjective health status in 256 patients with adrenal insufficiency on standard therapy based on cross-sectional analysis. J Clin Endocrinol Metab. 2007 Oct;92(10):3912-22. doi: 10.1210/jc.2007-0685. Epub 2007 Aug 7.
citation: Quinkler M, Oelkers W, Remde H, Allolio B. Mineralocorticoid substitution and monitoring in primary adrenal insufficiency. Best Pract Res Clin Endocrinol Metab. 2015 Jan;29(1):17-24. doi: 10.1016/j.beem.2014.08.008. Epub 2014 Aug 27.
citation: Kopp C, Linz P, Dahlmann A, Hammon M, Jantsch J, Muller DN, Schmieder RE, Cavallaro A, Eckardt KU, Uder M, Luft FC, Titze J. 23Na magnetic resonance imaging-determined tissue sodium in healthy subjects and hypertensive patients. Hypertension. 2013 Mar;61(3):635-40. doi: 10.1161/HYPERTENSIONAHA.111.00566. Epub 2013 Jan 21.
citation: Kopp C, Linz P, Wachsmuth L, Dahlmann A, Horbach T, Schofl C, Renz W, Santoro D, Niendorf T, Muller DN, Neininger M, Cavallaro A, Eckardt KU, Schmieder RE, Luft FC, Uder M, Titze J. (23)Na magnetic resonance imaging of tissue sodium. Hypertension. 2012 Jan;59(1):167-72. doi: 10.1161/HYPERTENSIONAHA.111.183517. Epub 2011 Dec 5.