NCT03505775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

9 months

First QC Date

April 12, 2018

Last Update Submit

April 12, 2018

Conditions

Adrenal Insufficiency

Keywords

Hormone replacementMineralocorticoids23Na-magnetic resonance imagingTissue sodium content

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

23Na-MRI

OTHER

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

Interventions

23Na magnetic resonance imagingDIAGNOSTIC_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.

23Na-MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)!

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Wuerzburg, Dept. of medicine I

Würzburg, 97080, Germany

Location

Related 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. doi: 10.1210/jc.2007-0685. Epub 2007 Aug 7.

    PMID: 17684047BACKGROUND

  • 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.

    PMID: 25617169BACKGROUND

  • 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.

    PMID: 23339169BACKGROUND

  • 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.

    PMID: 22146510BACKGROUND

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Stefanie Hahner, MD, Prof.

    University Hospital Wuerzburg, Dept. of medicine I, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2018

First Posted

April 23, 2018

Study Start

February 14, 2017

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

April 23, 2018

Record last verified: 2018-04

Locations

DE(1)