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NCT02256865 · ClinicalTrials.gov registry record · Early Phase 1
Hormonal Mechanisms of Sleep Restriction
A Early Phase 1 study, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
NCT02256865: Completed Early Phase 1 study, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
NCT02256865 is a Early Phase 1 study that has completed, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. The registered enrollment target is 40 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02256865, a Early Phase 1 study, has completed, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to study the effects of sleep restriction on the production of two hormones, cortisol and testosterone. The investigators aim to show that changing these hormones leads to insulin resistance, which is an important cause of type 2 diabetes mellitus. The investigators may also study the effect of sleep restriction on your food intake and cravings, mood, inflammation, metabolism (including bone), and other hormones. Inflammation is your body's response to stress and injury. Bone metabolism is a process of how your body regenerates (renews) new bone cells and removes old bone cells. Hormones are natural substances (materials) that are produced in the body and that influences (effects) the way the body grows or develops.
Primary Outcome
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.
Interventions
- DRUG Hydrocortisone
- DRUG Testosterone
- DRUG Ketoconazole
- DRUG Placebo for ketoconazole
- DRUG Placebo for hydrocortisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-10 |
| Est. Completion | 2023-10 |
| Phase | Early Phase 1 |
What the finished NCT02256865 record still lists
NCT02256865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 5 interventions - of which Hydrocortisone is the first listed.
NCT02256865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02256865 about?
NCT02256865 is a clinical study titled "Hormonal Mechanisms of Sleep Restriction". The purpose of this study is to study the effects of sleep restriction on the production of two hormones, cortisol and testosterone. The investigators aim to show that changing these hormones leads to insulin resistance, which is an important cause of type 2 diabetes mellitus. The investigators may ...
What is the current status of trial NCT02256865?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2014-10. Estimated completion is 2023-10.
What interventions are being tested in trial NCT02256865?
The interventions under investigation include: Hydrocortisone (DRUG), Testosterone (DRUG), Ketoconazole (DRUG), Placebo for ketoconazole (DRUG), Placebo for hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT02256865?
This trial is sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02256865's enrollment target sits among peer trials
40 629th of 2000 higher than 1,313 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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