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

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ClinicalTrials.gov Identifier: NCT03505775
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Wuerzburg University Hospital

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.

Condition or disease Intervention/treatment Phase
Adrenal Insufficiency Diagnostic Test: 23Na magnetic resonance imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017


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




Primary Outcome Measures :
  1. Muscle sodium content [ Time Frame: 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.

  2. Skin sodium content [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505775


Locations
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Germany
University Hospital Wuerzburg, Dept. of medicine I
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Wuerzburg University Hospital
Investigators
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Principal Investigator: Stefanie Hahner, MD, Prof. University Hospital Wuerzburg, Dept. of medicine I, Germany

Publications:
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Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT03505775     History of Changes
Other Study ID Numbers: 23NaMRT-AI
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wuerzburg University Hospital:
Hormone replacement
Mineralocorticoids
23Na-magnetic resonance imaging
Tissue sodium content

Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases