Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
NCT Number: NCT04286451
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.
Looking for future studies?
Notify MeFemale
Interventional
Not applicable
Baton Rouge, Louisiana, 70808, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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 be undergo 4 nights of sleep restriction.
Women will be undergo 4 nights of habitual sleep.
Time frame: 4 days
Insulin sensitivity by a 2-step hyperinsulinemic euglycemic clamp is performed at the end sleep conditions.
Time frame: 4 days
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
Release of free fatty acids and glycerol in culture.
Time frame: 4 days
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
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
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 (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 (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: 24 hours
Blood pressure monitoring will be performed for a 24-hour period during Day 3 of each sleep conditions.
Time frame: 4 days
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.
Pennington Biomedical Research Center
Other
Acronym: SLEEP-IN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06366399
Body Weight, Diabetes Mellitus
Salt Lake City, Utah, United States
View Trial DetailsNCT05459922
Chemically-Induced Disorders, Mental Disorders
Phoenix, Arizona, United States
View Trial DetailsNCT05485415
Mental Disorders, Nervous System Diseases
Basel, Switzerland
View Trial DetailsNCT06404112
COVID-19, Chronic Disease
Durham, North Carolina, United States
View Trial Details