N/A
N=12
Sleep Disruption Induced Impairments in Bone Formation
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03733483 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Change in Serum Pro-collagen 1 Intact N-terminal Propeptide (P1NP) — 72.1; 67.4 ng/mL — p=0.53
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleep Deprivation (Behavioral)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Male
- Sponsor
- University of Colorado, Denver
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Pro-collagen 1 Intact N-terminal Propeptide (P1NP) |
72.1; 67.4 | 0.53 |
| SECONDARY Change in Serum C-telopeptide of Type 1 Collagen (CTX) |
0.197; 0.459 | 0.10 |
Summary
This is a small intervention study with healthy males aged 20-65 years old who habitually sleep 7-9 hours/night.This study investigates if and how sleep restriction, independent of circadian misalignment (e.g. shift work, jet lag), induces a decrease in the bone formation marker Procollagen I Intact N-Terminal Propeptide (PINP). The specific aim is to evaluate the mechanistic underpinnings for the relationship between sleep restriction and suppression of bone formation. The study will enroll 12 healthy male participants and have a two-week intervention after enrollment.
Eligibility Criteria
Inclusion Criteria
o Adult men aged 20-65 years old who habitually sleep 7-9 hours/night.
Exclusion Criteria
- Regularly go to sleep after midnight;
- Shift work 1 year prior to study;
- Travel >1 time zone 4 weeks prior to study or need to travel during study;
- More than moderate activity level (>3 days of exercise per week >30 min of exercise per session);
- Current smokers (or within the previous year of study);
- Positive drug test at screening or laboratory admission;
- BMI > 30 kg/m2;
- Individuals who are concurrently participating in another research protocol that would influence their safe participation in this study. For example, participants involved in a study that requires blood draws or ingestion of experimental medication as this would increase the risk of participation in our study and/or compromise study results.
- Any clinically significant unstable medical or surgical condition within the last year (treated or untreated), including history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure (including febrile seizure-sleep loss has been used clinically to induce seizures in patients with epilepsy). Given the wide range of illnesses that are encountered in medical practice, it would not be possible to provide a comprehensive list of each and every disease that could serve as grounds for exclusion for the subject. However, the following is a list of illness categories that would certainly be grounds for exclusion: Connective Tissue and Joint Disorders; Neurologic/cognitive Disorders; Musculoskeletal Disorders; Immune Disorders; Chronobiologic Disorders; Cardiovascular Disorders; Respiratory Disorders; Kidney Disorders; Infectious Diseases; Hematopoietic Disorders; Neoplastic Diseases; and Endocrine and Metabolic Diseases.
- Self-reported or newly diagnosed medical condition that is still being investigated or is not under good control, including those identified on screening labs such as:
- Out-of-range values measured on a fasting blood sample: glucose > 100 mg/dl, thyroid stimulating hormone 5.0 uU/ml, abnormal alkaline phosphatase 117 U/l, creatinine, or hemoglobin 500 mg/day) or alcohol use (>14 standard drinks/week or >5 drinks in one sitting);
- Subjects with a history of heparin-induced thrombocytopenia (HIT) or an allergy to heparin;
- Inability to travel to the CU-AMC campus for study visits.
- Individuals with restrictive diets (e.g., vegan)
- Individuals with 25OHD < 20 ng/mL;
- Individuals with eGFR < 60 mL/min/1.73m2 as this is known to affect CTX measurements;
- T-score ≤ -2.5 (men ≥50 years old) or Z-score < -2.0 (men <50 years old) for bone mineral density (BMD) at the L-spine, femoral neck, or total hip on baseline DXA as compared to the DXA machine's normative database;
- Symptoms of active illness (e.g., fever); note that subject can be studied at a later date.
Data sourced from ClinicalTrials.gov (NCT03733483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.