RECRUITING

Sleep and Metabolism

Conditions

Sleep Deprivation Obesity Glucose Intolerance Weight Gain Food Selection sleep restriction circadian timing ad libitum

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Uncovering Sleep and Circadian Mechanisms Contributing to Adverse Metabolic Health

Quick Facts

Study Start:2023-12-01

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05775627

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Between 18 and 40 years of age * Drug free * Established disease-free status	1. Dietary restrictions * Participants who choose not to or cannot consume dairy products (milk, yogurt, cheese, ice cream) 2. Body Composition 3. Psychiatric/psychological suitability * Individuals with evidence of psychopathology on the BDI-II, or in a structured clinical interview with the physician * A history of severe psychiatric illnesses * Alcoholism * Drug dependency * Major depression * Manic depressive illness * Schizophrenic disorders * Panic disorder * Generalized anxiety disorder * Post-traumatic stress disorder * Agoraphobia * Claustrophobia * Paranoid personality disorder * Schizoid personality disorder * Schizotypal personality disorder * Borderline personality disorder * Antisocial personality disorder. * History of using antidepressant medication * History of using neuroleptic medication * History of using tranquilizers 4. Drug/alcohol use * Current non-smokers, and are required to have a history of less than 5 'pack years' of smoking 5. Medication/drug use 6. Prior shift work * Working irregular day and night hours * Regular night work * Rotating shift work f * Not have traveled more than 1 time zone during 3 months prior to the study 7. Chronobiologic and sleep disorders * Hypernychthemeral sleep/wake cycle * Delayed sleep phase syndrome (wake time \> 2 hours later than desired or habitually after 10:00 AM) * Advanced sleep phase syndrome (wake time \> 2 h earlier than desired or habitually before 5:00 AM) * Narcolepsy * Sleep apnea (apnea index \>15) * Insomnia (sleep complaint by history or polygraphically recorded sleep efficiency \< 80%) * Hypersomnia * Periodic Limb Movement (PLMS) (PLMS index \>15) * Nocturnal Paroxysmal Dystonia * REM-sleep behavior disorder * Nocturnal Enuresis; (self-report and first night in the laboratory) * Obstructive sleep apnea (apnea/hypopnea index \>5/h as determined by at-home monitoring) * The investigators will also exclude individuals with extreme chronotype using the Horne-Ostberg Morningness/Eveningness questionnaire (i.e., the Owl/Lark Questionnaire) 8. Diseases of the Cardiovascular System * Hypertension (systolic blood pressure \> 140 or diastolic blood pressure \> 90) * Heart failure * Cardiomyopathy * Cor pulmonale * Ischemic heart disease * Valvular heart disease * History of heart transplantation * Cardiac tumors * Pericardial disease 9. Metabolic Syndrome * HDL cholesterol of less than 40 mg/dL in men or less than 50 mg/dL in women * Systolic blood pressure \>135 mmHg or diastolic blood pressure \>85 mmHg * Fasting blood glucose ≥ 100 mg/dL * Triglycerides ≥ 150 mg/dL 10. Pre-Diabetes/Diabetes 11. Hypertension 12. Disorders of the Respiratory System * Asthma * Cystic fibroses * Chronic bronchitis * Emphysema * Airway obstruction * Interstitial lung diseases * Pulmonary hypertension * Lung neoplasms * ARDS 13. Disorders of the Kidney and Urinary Tract * Acute or chronic renal failure * History of renal transplantation * Tubulointerstitial diseases of the kidney * Urinary tract obstruction * Tumors of the urinary tract 14. Infectious Diseases * Infective endocarditis * HIV infection * Sexually transmitted diseases \[e.g., syphilis (including congenital syphilis and its sequelae), gonorrhea\], * Urinary tract infection * Osteomyelitis * Brucellosis * Toxoplasmosis, * Tuberculosis * Leptospirosis * Lyme disease * Mononucleosis * Hepatitis * Parasitic infections such as malaria, toxoplasmosis, giardiasis, schistosomiasis, leishmaniasis 15. Disorders of the Gastrointestinal System * Esophagitis * Peptic ulcer and gastritis * Neoplasms of the esophagus, stomach or bowel * Disorders of absorption * Inflammatory bowel disease * Diseases of the small and large intestine * Acute appendicitis * Cirrhosis or neoplasms of the liver * History of liver transplantation * Diseases of the gallbladder and bile ducts * Pancreatic disease 16. Disorders of the Immune System, Connective Tissue and Joints * AIDS * Systemic lupus erythematosus * Rheumatoid arthritis * Scleroderma * Ankylosing spondylitis * Vasculitis * Sarcoidosis 17. Disorders of the Hematopoietic System * Anemia * Leukemia * Myeloproliferative diseases * History of bone marrow transplantation 18. Neoplastic Diseases * Lymphoma * Carcinoma * Melanoma * Any other neoplastic diseases 19. Endocrine and Metabolic Diseases * Thyroid disease * Addison's Disease * Cushing's Syndrome * Aldosteronism * Hypoaldosteronism * Pheochromocytoma * Disorders of sexual differentiation that require hormone supplementation that may alter body weight * Disorders of neuroendocrine regulation * Diseases of the anterior pituitary and hypothalamus * Hemochromatosis porphyria * Wilson's Disease * Glycogen storage diseases * Diseases of the parathyroid gland * Metabolic bone disease * Disorders of phosphorus or magnesium metabolism * Paget's Disease 20. Neurologic Disorders * Epilepsy and disorders of consciousness * Dementia * Amnesic disorders * Neoplastic diseases of the central nervous system * Demyelinating diseases * Parkinson's Disease * Muscular dystrophy * Myasthenia gravis * Periodic paralysis * Dermatomyositis * Polymyositis * Infections of the nervous system * Stroke * History of transient ischemic attacks * Hydrocephalus * Tumors of the pituitary gland * Pinealoma * Intervertebral disc disease * Ataxia * Gilles de la Tourette Syndrome * Huntington's Disease * Tardive dyskinesia * History of recurrent migraine headaches * Neuromuscular disease. 21. Subjects must not be currently participating in another research study that would influence their safe participation in our study. Subjects must not be participating in a research study in which they do the following: * Ingest experimental medication * Give blood samples

Inclusion Criteria

Exclusion Criteria

* Between 18 and 40 years of age
* Drug free
* Established disease-free status

1. Dietary restrictions
* Participants who choose not to or cannot consume dairy products (milk, yogurt, cheese, ice cream)
2. Body Composition
3. Psychiatric/psychological suitability
* Individuals with evidence of psychopathology on the BDI-II, or in a structured clinical interview with the physician
* A history of severe psychiatric illnesses
* Alcoholism
* Drug dependency
* Major depression
* Manic depressive illness
* Schizophrenic disorders
* Panic disorder
* Generalized anxiety disorder
* Post-traumatic stress disorder
* Agoraphobia
* Claustrophobia
* Paranoid personality disorder
* Schizoid personality disorder
* Schizotypal personality disorder
* Borderline personality disorder
* Antisocial personality disorder.
* History of using antidepressant medication
* History of using neuroleptic medication
* History of using tranquilizers
4. Drug/alcohol use
* Current non-smokers, and are required to have a history of less than 5 'pack years' of smoking
5. Medication/drug use
6. Prior shift work
* Working irregular day and night hours
* Regular night work
* Rotating shift work f
* Not have traveled more than 1 time zone during 3 months prior to the study
7. Chronobiologic and sleep disorders
* Hypernychthemeral sleep/wake cycle
* Delayed sleep phase syndrome (wake time \> 2 hours later than desired or habitually after 10:00 AM)
* Advanced sleep phase syndrome (wake time \> 2 h earlier than desired or habitually before 5:00 AM)
* Narcolepsy
* Sleep apnea (apnea index \>15)
* Insomnia (sleep complaint by history or polygraphically recorded sleep efficiency \< 80%)
* Hypersomnia
* Periodic Limb Movement (PLMS) (PLMS index \>15)
* Nocturnal Paroxysmal Dystonia
* REM-sleep behavior disorder
* Nocturnal Enuresis; (self-report and first night in the laboratory)
* Obstructive sleep apnea (apnea/hypopnea index \>5/h as determined by at-home monitoring)
* The investigators will also exclude individuals with extreme chronotype using the Horne-Ostberg Morningness/Eveningness questionnaire (i.e., the Owl/Lark Questionnaire)
8. Diseases of the Cardiovascular System
* Hypertension (systolic blood pressure \> 140 or diastolic blood pressure \> 90)
* Heart failure
* Cardiomyopathy
* Cor pulmonale
* Ischemic heart disease
* Valvular heart disease
* History of heart transplantation
* Cardiac tumors
* Pericardial disease
9. Metabolic Syndrome
* HDL cholesterol of less than 40 mg/dL in men or less than 50 mg/dL in women
* Systolic blood pressure \>135 mmHg or diastolic blood pressure \>85 mmHg
* Fasting blood glucose ≥ 100 mg/dL
* Triglycerides ≥ 150 mg/dL
10. Pre-Diabetes/Diabetes
11. Hypertension
12. Disorders of the Respiratory System
* Asthma
* Cystic fibroses
* Chronic bronchitis
* Emphysema
* Airway obstruction
* Interstitial lung diseases
* Pulmonary hypertension
* Lung neoplasms
* ARDS
13. Disorders of the Kidney and Urinary Tract
* Acute or chronic renal failure
* History of renal transplantation
* Tubulointerstitial diseases of the kidney
* Urinary tract obstruction
* Tumors of the urinary tract
14. Infectious Diseases
* Infective endocarditis
* HIV infection
* Sexually transmitted diseases \[e.g., syphilis (including congenital syphilis and its sequelae), gonorrhea\],
* Urinary tract infection
* Osteomyelitis
* Brucellosis
* Toxoplasmosis,
* Tuberculosis
* Leptospirosis
* Lyme disease
* Mononucleosis
* Hepatitis
* Parasitic infections such as malaria, toxoplasmosis, giardiasis, schistosomiasis, leishmaniasis
15. Disorders of the Gastrointestinal System
* Esophagitis
* Peptic ulcer and gastritis
* Neoplasms of the esophagus, stomach or bowel
* Disorders of absorption
* Inflammatory bowel disease
* Diseases of the small and large intestine
* Acute appendicitis
* Cirrhosis or neoplasms of the liver
* History of liver transplantation
* Diseases of the gallbladder and bile ducts
* Pancreatic disease
16. Disorders of the Immune System, Connective Tissue and Joints
* AIDS
* Systemic lupus erythematosus
* Rheumatoid arthritis
* Scleroderma
* Ankylosing spondylitis
* Vasculitis
* Sarcoidosis
17. Disorders of the Hematopoietic System
* Anemia
* Leukemia
* Myeloproliferative diseases
* History of bone marrow transplantation
18. Neoplastic Diseases
* Lymphoma
* Carcinoma
* Melanoma
* Any other neoplastic diseases
19. Endocrine and Metabolic Diseases
* Thyroid disease
* Addison's Disease
* Cushing's Syndrome
* Aldosteronism
* Hypoaldosteronism
* Pheochromocytoma
* Disorders of sexual differentiation that require hormone supplementation that may alter body weight
* Disorders of neuroendocrine regulation
* Diseases of the anterior pituitary and hypothalamus
* Hemochromatosis porphyria
* Wilson's Disease
* Glycogen storage diseases
* Diseases of the parathyroid gland
* Metabolic bone disease
* Disorders of phosphorus or magnesium metabolism
* Paget's Disease
20. Neurologic Disorders
* Epilepsy and disorders of consciousness
* Dementia
* Amnesic disorders
* Neoplastic diseases of the central nervous system
* Demyelinating diseases
* Parkinson's Disease
* Muscular dystrophy
* Myasthenia gravis
* Periodic paralysis
* Dermatomyositis
* Polymyositis
* Infections of the nervous system
* Stroke
* History of transient ischemic attacks
* Hydrocephalus
* Tumors of the pituitary gland
* Pinealoma
* Intervertebral disc disease
* Ataxia
* Gilles de la Tourette Syndrome
* Huntington's Disease
* Tardive dyskinesia
* History of recurrent migraine headaches
* Neuromuscular disease.
21. Subjects must not be currently participating in another research study that would influence their safe participation in our study. Subjects must not be participating in a research study in which they do the following:
* Ingest experimental medication
* Give blood samples

Contacts and Locations

Study Contact

Andrew McHill, PhD

CONTACT

503-494-2594

mchill@ohsu.edu

Principal Investigator

Andrew McHill, PhD

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Study Locations (Sites)

Oregon Health & Science University

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

Andrew McHill, PhD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-12-01

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

sleep restriction
obesity
glucose intolerance
weight gain
circadian timing
ad libitum
food selection

Additional Relevant MeSH Terms

Sleep Deprivation
Obesity
Glucose Intolerance
Weight Gain
Food Selection