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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-14

Study Completion Date

2017-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Subclassification of the Syndrome of Inappropriate ADH Secretion

NCT01341665

Hyponatremia

COMPLETED

Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome

NCT02368379

Prader Willi Syndrome Adrenal Insufficiency

COMPLETED NA

Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks

NCT03374215

Adrenal Gland Neoplasm Hypertension Bone Diseases, Metabolic +2 more

RECRUITING

Catecholamine Reserve and Exercise Tolerance in Healthy Volunteers and Patients With Congenital Adrenal Hyperplasia

NCT00011791

Congenital Adrenal Hyperplasia Healthy

COMPLETED

Salt Wasting, Hydro-sodium Balance and Fludrocortisone Requirement in Congenital Adrenal Hyperplasia

NCT03550261

Congenital Adrenal Hyperplasia (CAH)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adrenal Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

23Na-MRI

A 23Na magnetic resonance imaging of the calf (muscle and skin) was performed in every participating patient after clinical and laboratory examinations.

Group Type OTHER

23Na magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes