Clinical Trial: Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism
Brief Summary:
The purpose of this study is to determine whether mifepristone is an effective treatment for hyperglycemia due to mild hypercortisolism.
- To test the hypothesis that GR blockade with mifepristone will decrease the severity of metabolic syndrome features as measured by waist circumference, lipid profile, body mass index, blood pressure and insulin resistance, measured by HOMA-IR score.
- To test the hypothesis that GR blockade with mifepristone will improve QoL, depression and anxiety scores, measured by validated assessments, in patients with mild hypercortisolism.
Detailed Summary:
Sponsor: Icahn School of Medicine at Mount Sinai
Current Primary Outcome: hyperglycemia [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Metabolic Syndrome [ Time Frame: 6 months ]Improvement in metabolic syndrome - outcomes include cortisol, fasting lipid profile, weight, BMI (kg/m2), waist circumference (in centimeters), and blood pressure
- Quality of Life [ Time Frame: 6 months ]Improvement in Quality of Life - completion of 3 validated QoL questionnaires (Cushing's Quality of Life questionnaire (CushingQoL), Nottingham Health Profile (NHP), and Hospital Anxiety and Depression Scale (HADS)), and the visual analogue scale (VAS) to quantify appetite. Patients will also complete the Beck Depression Inventory and the State Trait Anxiety Inventory (STAI).
Original Secondary Outcome: Same as current
Information By: Icahn School of Medicine at Mount Sinai
Dates:
Date Received: November 15, 2013
Date Started: November 2013
Date Completion:
Last Updated: September 29, 2016
Last Verified: September 2016