Clinical trial NCT01990560: Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism
Official title: Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mild Hypercortisolism
Keywords: mild hypercortisolism
Subclinical Cushing's Syndrome
Preclinical Cushing's Syndrome
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Incidentally noted adrenal nodule \<4 cm with benign imaging characteristics
* Evidence of mild hypercortisolism
* Evidence of diabetes or abnormal glucose tolerance

Exclusion Criteria:

* contraindication to mifepristone
* Indication for unilateral adrenalectomy
* Evidence of other adrenal hormone hypersecretion
* lactating mothers
* women of childbearing age unwilling to use an effective, nonhormonal form of contraception

Primary outcomes:
measure: A1C Level
timeFrame: Baseline, 3 months, and 6 months
measure: HOMA-IR
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Waist Circumference
timeFrame: Baseline and 6 months
measure: Body Mass Index (BMI)
timeFrame: Baseline and 6 months
measure: Fasting Lipid Profile
timeFrame: Baseline and 6 months
measure: Weight
timeFrame: Baseline and 6 months
measure: CushingQoL
timeFrame: Baseline and 6 months
measure: Nottingham Health Profile (NHP)
timeFrame: Baseline and 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and 6 months
measure: Quality of Life
timeFrame: Baseline and 6 months
measure: State Trait Anxiety Inventory (STAI)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Alice C Levine, MD
role: PRINCIPAL_INVESTIGATOR
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