An interventional study of Sleep Restriction and Habitual Sleep in Sleep Disturbance, Postmenopausal Symptoms and Insulin Sensitivity, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-16.
Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Diagnostic
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 (perimenopause) and into the postmenopausal years. Sleep disruption is one of the primary reasons why midlife women seek medical care, with up to 60% reporting significant sleep disturbances (e.g., trouble falling asleep, early morning waking, and hot flashes/night sweats). Despite the majority of women experiencing sleep disruption, no study has investigated the molecular mechanisms linking sleep disruption and the changes in metabolism that coincide with menopause.
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 and ex vivo. The investigators will randomize up to 10 healthy postmenopausal women with overweight/obesity and ≥6.5 hours of self-reported habitual nightly sleep to 4 nights of each sleep condition (sleep restriction and habitual sleep). After the fourth night of each sleep condition, the investigators will administer a two-step hyperinsulinemic-euglycemic clamp and collect skeletal muscle and adipose tissue samples prior to insulin infusion.
The overarching hypothesis is that sleep restriction will reduce skeletal muscle and adipose tissue insulin sensitivity compared to habitual sleep.
1,959 studies on the registry are indexed under Insulin Resistance; 305 are open to participants now.
This study's enrollment of 14 is below the median of 40 across 1,535 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.
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EXCLUSION CRITERIA:
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.
Women will undergo 4 nights of sleep restriction treatment.
Behavioral: Sleep Restriction
Women will undergo 4 nights of habitual sleep treatment.
Behavioral: Habitual Sleep
Women will be undergo 4 nights of sleep restriction.
Women will be undergo 4 nights of habitual sleep.
Glucose infusion rate (via 2-step hyperinsulinemic-euglycemic clamp) (in vivo)
Insulin sensitivity by a 2-step hyperinsulinemic euglycemic clamp is performed at the end sleep conditions.
Time frame: 4 days
Adipose tissue insulin sensitivity (via free fatty acid area-under-the-curve during the low-dose clamp) (in vivo)
During the low-dose insulin portion of the hyperinsulinemic-euglycemic clamp, free fatty acids will be samples across a 3-hour period to quantify a surrogate measure of adipose tissue insulin sensitivity in vivo.
Time frame: 4 days
Insulin-dependent suppression of lipolysis (via ex vivo adipose tissue biopsy analyses)
Release of free fatty acids and glycerol in culture.
Time frame: 4 days
Fat oxidation and substrate switching (via ex vivo skeletal muscle biopsy analyses)
Using primary myotubes, fat oxidation and substrate switching will be tested by measuring \[1-14C\]palmitate oxidation ± varying levels of glucose and pyruvate
Time frame: 4 days
Insulin sensitivity (via ex vivo skeletal muscle biopsy analyses)
Myotubes will be incubated ± insulin (100nM) in media containing: \[U-14C\]-glucose to measure glucose oxidation and glycogen synthesis; \[3H\]-2-deoxyglucose to assess glucose uptake; or unlabeled DMEM to test insulin signaling (western blot)
Time frame: 4 days
Gene expression (via ex vivo skeletal muscle biopsy analyses with RNASeq and RT-PCR)
Genes related to oxphos and circadian clock regulators will be assessed by RNASeq and confirmed with RT-PCR.
Time frame: 4 days
Glucose Area-Under-The-Curve (via 2-hour standard meal test)
Glucose area-under-the-curve (AUC) will be calculated throughout a 2-hour period following consumption of a standard meal (dinner shake) test on Day 4 of each sleep condition.
Time frame: 4 days
Insulin Area-Under-The-Curve (via 2-hour standard meal test)
Insulin area-under-the-curve (AUC) will be calculated throughout a 2-hour period following consumption of a standard meal (dinner shake) test on Day 4 of each sleep condition.
Time frame: 4 days
Blood pressure (via 24-hour ambulatory blood pressure monitoring)
Blood pressure monitoring will be performed for a 24-hour period during Day 3 of each sleep conditions.
Time frame: 24 hours
Resting metabolic rate (via indirect calorimetry)
O2 consumption and CO2 production will be measured by indirect calorimetry for 40 min (last 30 min will be used for calculations) using a metabolic cart. Resting metabolic rate will be derived using standard equations.
Time frame: 4 days
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Pennington Biomedical Research Center