Glucocorticoid Receptor Antagonism in Subclinical Cushings
Phase 1
Completed
- Conditions
- Subclinical Cushing's
- Registration Number
- NCT00721201
- Brief Summary
The purpose of this study is to assess the effects of reducing the activity of endogenous glucocorticoid in patients with low-grade cortisol excess
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Patients will be eligible for inclusion if: they are males and over 18, lack clinical features classically associated with Cushing's syndrome; have evidence of excess circulating cortisol
Exclusion Criteria
- Evidence of local or systemic malignancy; overt Cushing's syndrome; severe uncontrolled diabetes mellitus or hypertension; pregnancy; clinically significantly impaired cardiovascular function (e.g. stage IV cardiac failure); severe liver disease (liver enzymes ≥ 3 x the institutional upper limit of normal range); significantly impaired renal function (eGFR <30/min); uncontrolled severe active infection; treatment with approved or experimental steroidogenesis inhibitors, adrenolytic agents, within four weeks of admission; In women, known endometrial cancer, history of endometrial hyperplasia or vaginal bleeding of unknown cause; requirement for inhaled or systemic glucocorticoids for existing disease; impaired mental capacity or markedly abnormal psychiatric evaluation that precludes informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Blood pressure 8 weeks
- Secondary Outcome Measures
Name Time Method Glucose homeostasis 8 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie glucocorticoid receptor antagonism in subclinical Cushing's syndrome?
How does glucocorticoid receptor antagonism compare to standard-of-care treatments for subclinical Cushing's in efficacy and safety?
Which biomarkers are associated with response to glucocorticoid receptor antagonists in patients with subclinical cortisol excess?
What are the potential adverse events of glucocorticoid receptor antagonists in subclinical Cushing's and how are they managed?
Are there combination therapies involving glucocorticoid receptor antagonists that improve outcomes in subclinical Cushing's patients?
Trial Locations
- Locations (1)
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust🇬🇧Sheffield, United Kingdom