Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Alice C. Levine, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01990560
First received: November 15, 2013
Last updated: June 17, 2014
Last verified: June 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Mount Sinai School of Medicine:

Primary Outcome Measures:
  • hyperglycemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990560

Contacts
Contact: Aarti Ravikumar, MD 212-241-1500 aarti.ravikumar@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Aarti Ravikumar, MD    212-241-1500    aarti.ravikumar@mssm.edu   
Principal Investigator: Alice C Levine, MD         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Alice C Levine, MD Mount Sinai School of Medicine
  More Information

Publications:
Neary NM, booker OJ, Abel BS, Matta JR, Muldoon N, Sinaii N, Pettigrew RI, Neiman LK, Gharib AM. Hypercortisolism Is Associated With Increased Coronary Arterial Atherosclerosis: Analysis of Noninvasive Coronary Angiography Using Multidetector Computerized Tomography. J Clin Endocrinol Metab 2013; 98.

Responsible Party: Alice C. Levine, Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01990560     History of Changes
Other Study ID Numbers: GCO 13-1061
Study First Received: November 15, 2013
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
mild hypercortisolism
Subclinical Cushing's Syndrome
Preclinical Cushing's Syndrome

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

ClinicalTrials.gov processed this record on July 20, 2014