Evaluation of the Muscular and Cutaneous Sodium Storage by 23Na MRI in Patients With Chronic Adrenal Insufficiency

Adrenal Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03505775
• Other study ID #: 23NaMRT-AI
• Status: Completed
• Phase: N/A
• First received: April 12, 2018
• Last updated: April 12, 2018
• Start date: February 14, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: April 2018
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adrenal Insufficiency

Intervention

Diagnostic Test:
• 23Na magnetic resonance imaging
Imaging/diagnostic: Evaluation of the muscular and cutaneous sodium storage by 23Na magnetic resonance imaging. 23Na magnetic resonance imaging: 23NA-MRI protocol on a 3T scanner (Magnetom PRISMA, Siemens, Erlangen) implementing a 3D sequence.

Locations

Country	Name	City	State
Germany	University Hospital Wuerzburg, Dept. of medicine I	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. Epub 2007 Aug 7. — View Citation

Kopp C, Linz P, Dahlmann A, Hammon M, Jantsch J, Müller 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. — View Citation

Kopp C, Linz P, Wachsmuth L, Dahlmann A, Horbach T, Schöfl C, Renz W, Santoro D, Niendorf T, Müller 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle sodium content	Assessment of the sodium content of the calf muscle. Relative sodium signal intensities were calculated as ratio of tissue sodium intensity and the intensity of a vial containing a concentration of 100mmol/l.	6 months
Primary	Skin sodium content	Assessment of the sodium content of the calf skin. Relative sodium signal intensities were calculated as ratio of tissue sodium intensity and the intensity of a vial containing a concentration of 100mmol/l.	6 months