Actively Recruiting
Uncovering Sleep and Circadian Mechanisms Contributing to Adverse Metabolic Health
Led by Oregon Health and Science University · Updated on 2024-04-03
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how chronic sleep restriction and circadian timing independently and together affect energy metabolism, glucose tolerance, and food intake patterns. This randomized crossover study focuses on adults aged 18 to 40 who are healthy and drug-free, aiming to understand mechanisms contributing to obesity, diabetes, and related metabolic health issues. The study is designed to clarify how sleep loss might lead to weight gain despite increased wakefulness and energy use. Participants follow a 21-day protocol including 7 outpatient days with controlled diet and 14 inpatient days in a laboratory setting. During inpatient stays, they live in rooms without external time cues and undergo two sleep conditions: sleep restriction (about 5.5 hours sleep per 24 hours) and control (about 8 hours sleep per 24 hours), each lasting about 7 days with a crossover on day 8. Meals are provided with extra calories and snacks, allowing participants to eat freely. Sleep and activity are closely monitored using polysomnography, telemetry pills, and blood sampling. Throughout the study, participants complete sleep and mood assessments, cognitive tests, and have continuous monitoring of vital signs, energy expenditure, and hormone levels. Researchers measure many outcomes including circadian phase, glucose metabolism, heart rate, blood pressure, and various biochemical markers over the course of 14 days. The study includes baseline measurements and aims to understand the combined effects of sleep and circadian disruption on metabolic health.
CONDITIONS
Brief Title
Sleep and Metabolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 40 years of age
- Drug free
- Established disease-free status
You will not qualify if you...
- Dietary restrictions, including inability or choice to avoid dairy products
- Body mass index outside 18.5 to 25 kg/m2 or waist circumference 94 cm or greater for men and 80 cm or greater for women
- Evidence of psychiatric illness or history of major psychiatric disorders, including depression, anxiety, schizophrenia, and related medication use
- Drug or alcohol dependency history, current smokers with more than 5 pack years
- Use of prescribed or over-the-counter medications except birth control
- History of shift work or travel across more than one time zone within 3 months prior to study
- Diagnosed chronobiologic or sleep disorders such as sleep apnea, insomnia, narcolepsy, or extreme chronotype
- Cardiovascular diseases including hypertension, heart failure, ischemic disease, or heart transplantation
- Metabolic syndrome factors including abnormal cholesterol, blood pressure, blood glucose, or triglycerides
- Pre-diabetes or diabetes based on blood glucose or HbA1c levels
- Hypertension above 140/90 mmHg or beta blocker use
- Respiratory diseases such as asthma, chronic bronchitis, emphysema, or pulmonary hypertension
- Kidney and urinary tract diseases including renal failure or transplantation
- Infectious diseases like HIV, hepatitis, or sexually transmitted diseases
- Gastrointestinal diseases including esophagitis, inflammatory bowel disease, liver disease, or history of liver transplantation
- Immune, connective tissue, or joint disorders such as lupus or rheumatoid arthritis
- Hematopoietic diseases including anemia or leukemia
- Any neoplastic diseases including lymphoma or carcinoma
- Endocrine or metabolic diseases such as thyroid disorders, Addison's disease, Cushing's syndrome, or metabolic bone disease
- Neurologic disorders including epilepsy, dementia, Parkinson's disease, stroke, or neuromuscular diseases
- Current participation in another research study involving experimental medication or blood sampling
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 days before each laboratory visit
Participants maintain a consistent 8-hour sleep schedule at home for 7 days prior to each laboratory visit, verified by actigraphy, sleep logs, and call-ins. They also follow a 3-day outpatient isocaloric diet tailored to their daily energy needs, consuming only provided food with daily check-ins to confirm adherence.
Daily check-ins remotely
Duration - 14 days
Participants are admitted to an individual room without external time cues for 14 days. They undergo two 7-day conditions in a randomized crossover design: one with sleep restriction (approximately 5.5 hours sleep per 24 hours on a 20-hour day) and one control condition (8 hours sleep per 24 hours on a 20-hour day). Participants receive three meals per day with ad libitum access to snacks and undergo continuous monitoring including polysomnography, body temperature, and blood sampling.
Continuous inpatient stay with daily assessments
Trial Site Locations
Total: 1 location
1
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
A
Andrew McHill, PhD
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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