Hormonal Mechanisms of Sleep Restriction

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.

Conditions

• Insulin Resistance

Interventions

DRUG

Ketoconazole

Ketoconazole is taken 4 times a day

DRUG

Hydrocortisone

Hydrocortisone is taken 3 times a day

DRUG

Testosterone

Testosterone gel is applied once a day

DRUG

Placebo for ketoconazole

Placebo for ketoconazole

DRUG

Placebo for hydrocortisone

Placebo for hydrocortisone

DRUG

Placebo for testosterone

Placebo for testosterone

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  lead OTHER

Principal Investigators

• Peter Y Liu, MD PhD · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

22 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2017-11-30

Completion

2023-10-31

FDA Drug

Yes

Countries

• United States

Study Locations