Status:
COMPLETED
Effect of Sleep Restriction on Adipose Tissue and Skeletal Muscle Insulin Sensitivity
Lead Sponsor:
Pennington Biomedical Research Center
Conditions:
Sleep Disturbance
Postmenopausal Symptoms
Eligibility:
FEMALE
Phase:
NA
Brief Summary
Inadequate sleep is an independent risk factor for metabolic abnormalities (such as obesity, insulin resistance, and hyperglycemia). Women report sleep disruption during the menopause transition (peri...
Detailed Description
The investigators will conduct a randomized, crossover trial investigating the effect of sleep restriction compared to habitual sleep on adipose tissue and skeletal muscle insulin sensitivity in vivo ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Body mass index (BMI) 25-35 kg/m2 (inclusive)
- Postmenopausal (self-reported absence of menstrual cycle for 1-year)
- Within 10 years of final menstrual cycle
- Self-reported nocturnal time in bed of ≥6.5 hours per night (for ≥5 nights during a usual week)
- Willing to not take naps or engage in moderate-to-vigorous physical activity/exercise during both sleep conditions
- Willing to consume only the meals provided during both sleep conditions
- Willing to have adipose tissue and skeletal muscle biopsies
- Willing to have blood, as well as adipose and muscle tissue stored for future use
- EXCLUSION CRITERIA:
- Unstable weight in the last 3 months \[gain or loss ≥5% of body weight\]
- History of clinically diagnosed diabetes or a fasting blood glucose \>126 mg/dL
- History of polycystic ovary syndrome (PCOS)
- Currently taking antihypertension medication known to affect adipose tissue and skeletal muscle metabolism (e.g., diuretics may be allowed)
- Chronic use of systemic glucocorticoids
- Chronic use of atypical antipsychotic or bipolar medications
- Initiation of antidepressant medication within the last 3 months
- Previous bariatric surgery (or other surgeries) for obesity or weight loss
- Chronic use of prescription or 'effective' over-the-counter medications affecting sleep, circadian rhythms, or glucose metabolism †
- Chronic use of hormone replacement therapy
- History of clinically diagnosed sleep apnea
- Shift workers (e.g., individuals awake or working between Midnight and 5AM)
- Inability to spend 5 nights at Pennington Biomedical
- Unwilling to eat only the food and drink provided by study staff while in the study
- Unwilling to maintain a consistent and prescribed sleep schedule while in the study
- Unwilling to maintain a consistent eating schedule while in the study
- Sporadic use of certain medications is fine (however, enrollment will depend on a case-by-case basis). If taking sporadically, women should not be taking the medication for 1-month prior to the first Run-In period.
Exclusion
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04286451
Start Date
July 28 2020
End Date
April 13 2022
Last Update
November 16 2022
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808