Phase 4
N=8
Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism
Mild Hypercortisolism
Bottom Line
View on ClinicalTrials.gov: NCT01990560 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: A1C Level — 6.2; 6.1375; 6.125 percentage of red blood cells
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mifepristone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A1C Level |
6.2; 6.1375; 6.125 | — |
| PRIMARY HOMA-IR |
2.418; 1.465 | — |
| SECONDARY Waist Circumference |
103.25; 99.3125 | — |
| SECONDARY Body Mass Index (BMI) |
35.1538; 34.5463 | — |
| SECONDARY Fasting Lipid Profile |
178.63; 171.43; 97.88; 104.37; 59.13; 46.86 | — |
| SECONDARY Weight |
99.57; 97.75 | — |
| SECONDARY CushingQoL |
37.2857; 38.7857 | — |
| SECONDARY Nottingham Health Profile (NHP) |
32.60; 45.40; 24.88; 32.08; 27.03; 35.09 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) |
16.2857; 11.1667 | — |
| SECONDARY Quality of Life |
16.1429; 11.7143 | — |
| SECONDARY State Trait Anxiety Inventory (STAI) |
25.4286; 28.8571 | — |
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
Data sourced from ClinicalTrials.gov (NCT01990560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.