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Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism

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ClinicalTrials.gov Identifier: NCT01990560
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alice C. Levine, Icahn School of Medicine at Mount Sinai

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mild Hypercortisolism Drug: Mifepristone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism
Study Start Date : November 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Mifepristone
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
 Drug: Mifepristone
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


Outcome Measures
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Primary Outcome Measures :
  1. A1C Level [ Time Frame: Baseline, 3 months, and 6 months ]
    Change in hyperglycemia assessed by HbA1c, also known as glycated hemoglobin

  2. HOMA-IR [ Time Frame: Baseline and 6 months ]
    Change in hyperglycemia assessed by Homeostatic Model Assessment of Insulin Resistance, HOMA-IR (a validated assessment of insulin resistance). HOMA-IR = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.


Secondary Outcome Measures :
  1. Waist Circumference [ Time Frame: Baseline and 6 months ]
    Change in metabolic syndrome as assessed by waist circumference

  2. Body Mass Index (BMI) [ Time Frame: Baseline and 6 months ]
    Change in metabolic syndrome as assessed by BMI

  3. Fasting Lipid Profile [ Time Frame: Baseline and 6 months ]
    Change in metabolic syndrome as assessed by fasting lipid profile which includes Low-density lipoproteins ( LDL), High-density lipoproteins (HDL), and Triglycerides (Trigs) levels, and total cholesterol which is the sum of HDL plus LDL and 20% of trigs.

  4. Weight [ Time Frame: Baseline and 6 months ]
    Change in metabolic syndrome as assessed by weight

  5. CushingQoL [ Time Frame: Baseline and 6 months ]
    Change in Quality of Life - as assessed by the Cushing's Quality of Life questionnaire (CushingQoL). Patient completed questionnaire, 12 items, each scored on a 5 point score, resulting in a score of 12 (worst) to 60 (best) where higher scores indicate more favorable QOL.

  6. Nottingham Health Profile (NHP) [ Time Frame: Baseline and 6 months ]
    Change in Quality of Life as assessed by the Nottingham Health Profile (NHP) which is a patient reported questionnaire to measure a patient's view of their own health status. There are 6 sections (Energy level, Pain, Emotional Reaction, Sleep, Social Isolation, and Physical Abilities. All questions have only yes/no answer options and each section score is weighted so that the possible score range for any section is 0-100. The higher the score, the greater the number and severity of problems.

  7. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline and 6 months ]
    Change in Quality of Life as assessed by the Hospital Anxiety and Depression Scale (HADS). Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression

  8. Quality of Life [ Time Frame: Baseline and 6 months ]
    Change in Quality of Life as assessed by the Beck Depression Inventory. a 21-question multiple choice, self-report inventory that is used for measuring the severity of anxiety. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe anxiety symptoms.

  9. State Trait Anxiety Inventory (STAI) [ Time Frame: Baseline and 6 months ]
    Change in Quality of Life - as assessed by the State Trait Anxiety Inventory (STAI). The State-Trait Anxiety Inventory both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored and averaged. Total scores range from 20 to 80, with higher scores correlating with greater anxiety.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990560


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Alice C Levine, MD Icahn School of Medicine at Mount Sinai
More Information
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Publications:

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Responsible Party: Alice C. Levine, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01990560    
Other Study ID Numbers: GCO 13-1061
First Posted: November 21, 2013    Key Record Dates
Results First Posted: March 2, 2018
Last Update Posted: March 2, 2018
Last Verified: January 2018
Keywords provided by Alice C. Levine, Icahn School of Medicine at Mount Sinai:
mild hypercortisolism
Subclinical Cushing's Syndrome
Preclinical Cushing's Syndrome
Additional relevant MeSH terms:
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Cushing Syndrome
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
 Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Hormonal
Menstruation-Inducing Agents