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Completed

NCT Number: NCT01990560

Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism

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.

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Key information

Conditions

Mild Hypercortisolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone

Drug

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 names: Korlym

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 21, 2013
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.