Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3173
Source ID: NCT02256865
Associated Drug: Ketoconazole
Title: Hormonal Mechanisms of Sleep Restriction
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Insulin Resistance
Interventions: DRUG: Ketoconazole|DRUG: Hydrocortisone|DRUG: Testosterone|DRUG: Placebo for ketoconazole|DRUG: Placebo for hydrocortisone|DRUG: Placebo for testosterone
Outcome Measures: Primary: Insulin Sensitivity, Insulin sensitivity determined by minimal model of a frequently sampled oral glucose tolerance test (OGTT).This method is extensively validated, and previously utilized by us., 3 years | Secondary: Disposition index, Disposition index (determined by minimal model of the same OGTT), 3 years|C-peptide glucose dose-response, C-peptide glucose dose-response (also calculated from the same OGTT), 3 years|Lapses on Psychomotor Vigilance Task, Measure of psychomotor performance, 3 years|Karolinska Sleepiness Scale, Measures sleepiness, 3 years|Urinary Catecholamines, Measures sympathetic/parasympathetic activity, 3 years|Heart Rate Variability, Measures sympathetic/parasympathetic activity, 3 years|Free Fatty Acid Concentrations, Measures potential mediator of insulin resistance, 3 years|Inflammatory marker panel, blood interleukin-6, sTNFr2, IL1ra, CRP, NFkB concentrations, 3 years|Computerized cognitive testing, Two card gambling task, modified Sternberg working memory task, 3 years|Bone turnover panel, P1NP (bone formation marker) and NTX (bone resorption marker), 3 years|Food cravings,, Food Craving Index, 3 years|Assessment of mood states., Profile of Mood States (POMS), 3 years|Food intake, meal and snack consumption calculation, 3 years|Hunger measurement, Flint visual analogue scale, 3 years | Other: Epigenetics, Explorative study, 3 years
Sponsor/Collaborators: Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Gender: MALE
Age: ADULT
Phases: EARLY_PHASE1
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2014-10
Completion Date: 2023-10
Results First Posted:
Last Update Posted: 2023-11-07
Locations: Los Angeles Biomedical Research Institute, Torrance, California, 90509, United States
URL: https://clinicaltrials.gov/show/NCT02256865

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D438 Levoketoconazole small molecule DB05667 Details
D215 Hydrocortisone small molecule DB00741 Details
D176 Testosterone small molecule DB00624 Details