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Corticosteroid
Ketoconazole for Insulin Resistance
Phase < 1
Waitlist Available
Led By Peter Y Liu, MD PhD
Research Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is studying the effects of sleep restriction on the production of two hormones, cortisol and testosterone. The goal is to see if changing these hormones leads to insulin resistance, which is a cause of type 2 diabetes mellitus. The trial may also study the effect of sleep restriction on food intake and cravings, mood, inflammation, metabolism (including bone), and other hormones.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insulin Sensitivity
Secondary outcome measures
Assessment of mood states.
Bone turnover panel
C-peptide glucose dose-response
+11 moreOther outcome measures
Epigenetics
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Drug and Placebo Group 1Active Control6 Interventions
Ketoconazole is taken 4 times a day Hydrocortisone is taken 3 times a day Testosterone gel is applied once a day
Group II: Placebo and Drug Group 2Placebo Group6 Interventions
Placebo pills and gel is used in place. Placebo for Ketoconazole is taken 4 times a day Placebo for Hydrocortisone is taken 3 times a day Placebo for testosterone gel is applied once a day.
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Who is running the clinical trial?
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor
102 Previous Clinical Trials
46,393 Total Patients Enrolled
Peter Y Liu, MD PhDPrincipal InvestigatorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of brain injury or learning disability.You are currently smoking cigarettes.You have trouble sleeping or have a disorder that affects your sleep patterns.You have had a bad reaction to staying awake for long periods of time or to any of the medications that will be given.Your body mass index (BMI) is between 20 and 28 kg/m2.You have recently used or are currently using drugs or alcohol excessively.You have a history of mental health problems.You have certain medical conditions or illnesses.You have difficulty seeing or hearing, unless it can be fixed with corrective measures to bring it back to normal.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo and Drug Group 2
- Group 2: Drug and Placebo Group 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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