Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
NCT05775627

Sleep and Metabolism

Led by Oregon Health and Science University · Updated on 2024-04-03

20

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this study is to uncover sleep and circadian mechanisms contributing to adverse metabolic health. The protocol is a 21 day (7 outpatient days, 14 inpatient days) mechanistic randomized-crossover study designed to identify the impact of chronic sleep restriction and circadian timing, independently and in combination on energy metabolism and identify the independent and combined effects on glucose tolerance.

CONDITIONS

Official Title

Sleep and Metabolism

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 40 years of age
  • Drug free
  • Established disease-free status
Not Eligible

You will not qualify if you...

  • Dietary restrictions including inability or unwillingness to consume dairy products
  • Body mass index (BMI) outside 18.5 to less than 25 kg/m2 and waist circumference of 94 cm or more for men, 80 cm or more for women
  • Evidence of significant psychiatric or psychological disorders including major depression, bipolar disorder, schizophrenia, anxiety disorders, personality disorders, or use of antidepressant, neuroleptic, or tranquilizer medications
  • History of drug or alcohol dependency; current smokers or history exceeding 5 pack years
  • Use of any prescribed or over-the-counter medications except birth control
  • History of shift work, irregular work hours, or travel across time zones in the past year
  • Diagnosed chronobiologic or sleep disorders including delayed or advanced sleep phase syndrome, narcolepsy, sleep apnea, insomnia, hypersomnia, periodic limb movement syndrome, REM-sleep behavior disorder, nocturnal enuresis, or extreme chronotype
  • Cardiovascular diseases such as hypertension (blood pressure above 140/90 mmHg), heart failure, cardiomyopathy, ischemic heart disease, valvular heart disease, history of heart transplantation, cardiac tumors, or pericardial disease
  • Metabolic syndrome factors including low HDL cholesterol, elevated blood pressure, fasting blood glucose of 100 mg/dL or higher, or high triglycerides
  • Pre-diabetes or diabetes based on fasting blood glucose and hemoglobin A1c levels
  • Respiratory disorders including asthma, cystic fibrosis, chronic bronchitis, emphysema, airway obstruction, interstitial lung diseases, pulmonary hypertension, lung tumors, or ARDS
  • Kidney and urinary tract diseases such as renal failure, transplantation, tubulointerstitial diseases, obstruction, or tumors
  • Infectious diseases including endocarditis, HIV, sexually transmitted diseases, urinary tract infections, osteomyelitis, brucellosis, toxoplasmosis, tuberculosis, leptospirosis, Lyme disease, mononucleosis, hepatitis, and parasitic infections
  • Gastrointestinal disorders including esophagitis, peptic ulcer, neoplasms, absorption disorders, inflammatory bowel disease, appendicitis, liver diseases, gallbladder and bile duct diseases, pancreatic diseases, or history of liver transplantation
  • Immune system, connective tissue, or joint diseases such as AIDS, lupus, rheumatoid arthritis, scleroderma, ankylosing spondylitis, vasculitis, or sarcoidosis
  • Hematopoietic system disorders including anemia, leukemia, myeloproliferative diseases, or history of bone marrow transplantation
  • Neoplastic diseases including lymphoma, carcinoma, melanoma, or other cancers
  • Endocrine and metabolic diseases such as thyroid disease, Addison's, Cushing's syndrome, adrenal disorders, hormonal disorders affecting body weight, neuroendocrine diseases, pituitary or hypothalamus diseases, hemochromatosis, porphyria, Wilson's disease, glycogen storage diseases, parathyroid diseases, metabolic bone diseases, or Paget's disease
  • Neurologic disorders including epilepsy, dementia, amnesia, CNS tumors, demyelinating diseases, Parkinson's disease, muscular dystrophy, myasthenia gravis, periodic paralysis, dermatomyositis, polymyositis, nervous system infections, stroke, transient ischemic attacks, hydrocephalus, pituitary tumors, pinealoma, disc disease, ataxia, Tourette syndrome, Huntington's disease, tardive dyskinesia, recurrent migraines, or neuromuscular diseases
  • Participation in another research study involving experimental medication or blood sample collection that could affect safe participation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

A

Andrew McHill, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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