Ketoconazole Effects on the Daily Cortisol Rhythm in Mild Autonomous Cortisol Secretion

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT07649317
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Mild Autonomous Cortisol Secretion

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketoconazole — DRUG
    Antifungal medication that blocks adrenal steroidogenesis, including cortisol production, at higher doses

Study Details

Background: Cortisol is a hormone in the blood. Cortisol levels normally go down at night and up in the morning. Mild autonomous cortisol secretion (MACS) is a disease in which the body makes too much cortisol. MACS can cause high blood pressure, diabetes, and/or weight gain. Researchers think these problems may be caused by higher cortisol levels at night. Objective: To compare daily cortisol levels in people with MACS with those in healthy people. Also, to test a drug (ketoconazole) that may help lower cortisol levels in people with MACS. Eligibility: People aged 18 years and older with MACS. Healthy volunteers are also needed. Design: Participants with MACS will have a 2-night stay in the hospital. Day 1: A thin tube called a catheter will be inserted into a vein in the arm. Blood will be collected through the catheter every 2 hours starting at 8 PM. Participants will begin a 24-hour urine collection. Saliva will be collected every 6 hours for 24 hours. Day 2: Participants will take 2 tablets of the study drug ketoconazole with their evening meal. Blood will be collected via the catheter at regular intervals throughout the night. Day 3: Participants will leave the hospital in the morning. Healthy volunteers will be screened with a physical exam and blood tests. They will be tested to make sure they do not have MACS. To do this, they will take a drug (dexamethasone) at 11 PM on a day they choose; then they will return the next morning for a blood test. Healthy volunteers will have a 1-night stay in the hospital. They will have blood, urine, and saliva collected for 24 hours.

Key Dates

Start date
Jun 21, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • No Intervention: Healthy volunteers
    Healthy volunteers, matched to MACS participants by age, sex, BMI and (women only) menopausal status. Will undergo 24-hour sampling to obtain healthy diurnal serum cortisol curves for comparison.
  • Experimental: Mild autonomous cortisol secretion (MACS)
    Patients with mild autonomous cortisol secretion (MACS) who will undergo baseline sampling of diurnal cortisol , followed by sampling after a single dose of ketoconazole 400 mg.

Primary Outcome Measure

To assess the circadian rhythm of serum cortisol in participants with MACS compared to that in matched healthy volunteers (HV). [ Time Frame: Baseline sampling obtained during 24 hours in each participant. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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