To investigate cortisol and ACTH rhythm (frequency, amplitude and regularity of cortisol and ACTH secretory pulses) in patients with SCS and bilateral adrenal involvement.
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cortisol and ACTH rhythm expressed as frequency/amplitude and regularity of
cortisol and ACTH secretory pulses.
Secondary outcome
Comparance of cortisol and ACTH rhythm expressed as frequency/amplitude and
regularity of cortisol and ACTH secretory pulses of patients with subclinical
cushing syndrome to patients with full-blown Cushing syndrome and healthy
controls, previously investigated by means of 10 minute sampling in the LUMC in
Leiden.
Background summary
Patients with subclinical Cushing syndrome (SCS) have autonomous, possibly
increased cortisol secretion without the evident clinical features of Cushing
syndrome.
Despite the lack of the typical Cushing fenotype, long term morbidity has been
reported in SCS patients, related to disturbed cortisol secretion.
Therefore, it is important to know to what extent cortisol and ACTH secretion
are disturbed, and whether therapeutic intervention is necessary. Especially in
patients with SCS and bilateral adrenal pathology this information is important
because both therapeutic options have major impact (surgery: bilateral
adrenalectomy will result in Addison (hypocortisolism), medically: ketoconazol
produces frequent and potential side effects).
In patients with Cushing syndrome (both the pituitary-dependent and the
adrenal-depent type) both the rhythm as well as the regularity of cortisol and
ACTH secretion, as determined by obtaining a 24-hour profile, is disturbed.
In patients with SCS such a 24-hour profile of cortisol and ACTH secretion has
never been performed.
The results will give more insight in the (disturbance of) cortisol and ACTH
profile of SCS patients. This will help to make a decision with regard to the
necessity of therapeutic intervention.
Study objective
To investigate cortisol and ACTH rhythm (frequency, amplitude and regularity of
cortisol and ACTH secretory pulses) in patients with SCS and bilateral adrenal
involvement.
Study design
Blood sampling every 10 minutes for 24 hours and determination of cortisol and
ACTH in patients with SCS with bilateral adrenal involvement and compare these
to previously investigated controls and patients (with pituitary-dependent and
adrenal-dependent forms of Cushing disease).
Study burden and risks
The burden for participating patients is a venapuncture to determine
Hemoglobin, and if Hemoglobin is normal, a 36 hours hospital stay, with
insertion of an indwelling iv cannula once, and withdrawal of blood from the
cannula every 10 minutes. In total an amount of 360 ml blood will be withdrawn,
this is less than the amount of blood withdrawn from blood donors (500 ml in 15
minutes). There is no risk for the patients participating.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Patients known at the outpatient clinic of Endocrine Diseases in the UMCN St. Radboud, with subclinical Cushing syndrome with bilateral adrenal pathology
Exclusion criteria
Patients with SCS in whom adrenalectomy has been done, and patients with SCS and unilateral adrenal involvement and patients with SCS due to pituitary pathology
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17355.091.07 |