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

Evaluation of the Muscular and Cutaneous Sodium Storage by 23Na Magnetic Resonance Imaging in Patients With Chronic Adrenal Insufficiency Compared to Healthy Subjects

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03505775

Enrollment

Registered

2018-04-23

Start date

2017-02-14

Completion date

2017-10-31

Last updated

2018-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Insufficiency

Keywords

Hormone replacement, Mineralocorticoids, 23Na-magnetic resonance imaging, Tissue sodium content

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.

Interventions

DIAGNOSTIC_TEST23Na 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Muscle sodium content	6 months	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.
Skin sodium content	6 months	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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026