Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism
|ClinicalTrials.gov Identifier: NCT01990560|
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : September 30, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Mild Hypercortisolism||Drug: Mifepristone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism|
|Study Start Date :||November 2013|
|Primary Completion Date :||September 2016|
|Study Completion Date :||September 2016|
U.S. FDA Resources
Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
All patients in the study will receive daily Mifepristone for 6 months and primary and secondary outcomes will be assessed before and after the 6 month treatment period
Other Name: Korlym
- hyperglycemia [ Time Frame: 6 months ]Improvement in hyperglycemia - fasting glucose, HbA1c, HOMA-IR (a validated assessment of insulin resistance, HOMA-IR = (glucose md/dl x insulin mg/dl)/405)
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990560
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Alice C Levine, MD||Icahn School of Medicine at Mount Sinai|