Ketoconazole Effects on the Daily Cortisol Rhythm in Mild Autonomous Cortisol Secretion (NCT07649317) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Ketoconazole Effects on the Daily Cortisol Rhythm in Mild Autonomous Cortisol Secretion
United States36 participantsStarted 2026-07-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18 years or older.
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Agreement to adhere to Lifestyle Considerations throughout the study.
. Co-enrollment in protocol 19DK0066.
. Abnormal low-dose overnight dexamethasone suppression test (morning serum cortisol \>1.8 mcg/dL following 1 mg oral dexamethasone between 2300-0000h the evening prior)
. One or more \>=1 cm adrenal nodule(s) on one or both adrenal glands on CT or MRI
. One normal 24-hour urine free cortisol value (per the reference range of the assay used).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the circadian rhythm of serum cortisol in participants with MACS compared to that in matched healthy volunteers (HV).
Timeframe: Baseline sampling obtained during 24 hours in each participant.
Trial details
NCT IDNCT07649317
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
. Inability to comply with all study procedures and visits.
. Inability of subject to understand or to sign a written informed consent document.
. Pregnancy or breastfeeding.
. Use of estrogen-containing oral contraceptives or oral estrogen therapy within 6 weeks before inpatient admission, due to possible increases in serum corticosteroid-binding globulin, and thereby total cortisol.
. Use of medications within 2 weeks before inpatient admission that can block glucocorticoid production or action: ketoconazole (systemic), levoketoconazole, metyrapone, osilodrostat, mifepristone.
. Use of oral, injectable, or inhaled glucocorticoids (unless intermittent, for symptomatic asthma) within the year before inpatient admission. Use of topical non-hydrocortisone containing potent glucocorticoids on more than 36 square inches within six months before inpatient admission.
. Anemia (hemoglobin \<13.7 g/dL for males, \<11.2 g/dL for females).
. Daily alcohol risk use (\>2 standard drinks per day by self-report during screening visit).