Sleep Loss for Insulin Resistance
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to examine the impact of timed cortisol release or differently timed cortisol rhythms on insulin resistance in both men and women undergoing sleep restriction. Chronic sleep loss is highly prevalent, affecting 1 in 3 adults in the US. Chronic sleep loss causes stress which induces insulin resistance and leads to obesity and type 2 diabetes. Many factors contribute to sleep loss including shift work, environmental disturbances, sleep/circadian disorders and comorbid medical and mental health conditions. Sleep loss increases the stress hormone cortisol in the evening and decreases daytime testosterone. Examining these hormones in a controlled laboratory environment under different sleep schedules may help researchers find solutions for adults experiencing negative health consequences related to chronic sleep loss.
Who Is on the Research Team?
Peter Liu, MBBS, PhD
Principal Investigator
Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center
Hans P.A. Van Dongen, PhD
Principal Investigator
Washington State University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo sleep restriction and circadian misalignment with cortisol rhythm manipulation using a dual-hormone clamp
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Metyrapone And Hydrocortisone
How Is the Trial Designed?
2
Treatment groups
Active Control
Cortisol will be clamped with oral administration of Metyrapone, which blocks endogenous cortisol biosynthesis. A loading dose of 3,000mg will be given at 10:00 on day 2. Every 4 hours throughout the sleep restriction and sleep deprivation phases, 500mg will be administered beginning at 14:00 on day 2 and ending with a dose at 18:00 on day 5. Using a subcutaneous pump, hydrocortisone is administered here as physiological replacement, with pulses every 3 hours beginning at 10:00 on day 2. Participants assigned to the misaligned cortisol rhythm condition will receive: lowest doses (0.5mg) at 22:00 and 01:00; moderate doses (2.3mg) at 13:00, 16:00, and 19:00; and highest doses (4.0mg) at 04:00, 07:00, and 10:00. An oral 25mg dose of hydrocortisone will be given at the end of the constant routine period to prevent any future hypocortisolemia associated with the hormone clamp.
Participants assigned to the misaligned cortisol rhythm condition (Condition A) will receive: lowest doses (0.5mg) at 22:00 and 01:00; moderate doses (2.3mg) at 13:00, 16:00, and 19:00; and highest doses (4.0mg) at 04:00, 07:00, and 10:00. Participants assigned to the realigned cortisol rhythm condition (Condition B) will receive their doses at a 12-hour offset from the misaligned condition, with: lowest doses (0.5mg) at 10:00 and 13:00; moderate doses (2.3mg) at 01:00, 04:00, and 07:00; and highest doses (4.0mg) at 16:00, 19:00, and 22:00. In both conditions, the last subcutaneous dose will be administered at 19:00 on day 5. Each pulse is delivered at a rate of 0.1mg/sec (of hydrocortisone diluted to 10mg/mL) and replicates an extensively validated protocol developed by others, and refined by us. An oral 25mg dose of hydrocortisone will be given at the end of the constant routine period to prevent any future hypocortisolemia associated with the hormone clamp.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington State University
Lead Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborator
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