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Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01990560
First Posted: November 21, 2013
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alice C. Levine, Icahn School of Medicine at Mount Sinai
  Purpose

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 Intervention Phase
Mild Hypercortisolism Drug: Mifepristone Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alice C. Levine, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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).


Enrollment: 8
Study Start Date: November 2013
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
Principal Investigator: Alice C Levine, MD Icahn School of Medicine at Mount Sinai
  More Information

Publications:

Responsible Party: Alice C. Levine, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01990560     History of Changes
Other Study ID Numbers: GCO 13-1061
First Submitted: November 15, 2013
First Posted: November 21, 2013
Last Update Posted: November 20, 2017
Last Verified: September 2016

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:
Cushing Syndrome
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Glucocorticoids
Mifepristone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents