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.
Study Description: This study will compare the circadian rhythm of serum cortisol in subjects with Mild Autonomous Cortisol Secretion (MACS) and healthy volunteers (HVs). At the end of 24-hour baseline sampling, participants with MACS will receive a single dose of ketoconazole (KTZ) and undergo continued serial sampling to assess its effect on cortisol production. We hypothesize that subjects with MACS have decreased diurnal variability of serum cortisol, leading to relative excess in the evening and early overnight hours. We also hypothesize that a single dose of KTZ lowers cortisol enough to restore a near-normal diurnal pattern. Objectives: Primary Objective: To assess the circadian rhythm of serum cortisol in participants with MACS compared to that in matched HVs. Secondary Objective: To determine the degree of serum cortisol reduction induced by a single dose of 400 mg KTZ in participants with MACS. Exploratory Objectives: 1. To define the time to greatest decrease of cortisol after a dose of KTZ; 2. To compare serum levels of cortisol precursors in MACS and HVs; 3. To assess which steroidogenic enzymes are most affected by KTZ; 4. To compare the nadir-to-peak cortisol excursion in MACS and HVs; 5. To compare awake and asleep urine cortisol levels in MACS and HVs; 6. To assess the correlation of salivary cortisol and cortisone with serum Cortisol. Endpoints: Primary Endpoints: Difference in serum cortisol between MACS and HV at timepoints 1600h, 1800h, 2000h, 2200h, 0000h and 0200h during 24-hour sampling. Secondary Endpoints: Absolute and relative reduction of serum cortisol from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours after KTZ. Exploratory Endpoints: Time to maximum cortisol reduction after KTZ compared to baseline sampling; serum cortisol precursors during serial sampling before (MACS and HV) and after (MACS only) KTZ dosing; absolute and relative difference in serum cortisol from nadir to peak; urine free cortisol values while awake and asleep; salivary cortisol/cortisone and serum cortisol levels at timepoints 0000h, 0600h, 1200h and 1800h.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
Antifungal medication that blocks adrenal steroidogenesis, including cortisol production, at higher doses
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
RECRUITINGTo assess the circadian rhythm of serum cortisol in participants with MACS compared to that in matched healthy volunteers (HV).
Difference in serum cortisol between MACS and HV at timepoints 1600h, 1800h, 2000h, 2200h, 0000h and 0200h during 24-hour sampling.
Time frame: Baseline sampling obtained during 24 hours in each participant.
To determine the degree of serum cortisol reduction induced by a single dose of 400 mg ketoconazole (KTZ) in participants with MACS.
Difference in serum cortisol after KTZ compared to baseline sampling during the same timepoints the day prior.
Time frame: Baseline sampling for 24 hours followed by post-KTZ sampling for 12 hours in participants with MACS.
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