Clinical Trials Directory

Trials / Completed

CompletedNCT04286451

Effect of Sleep Restriction on Adipose Tissue and Skeletal Muscle Insulin Sensitivity

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Pennington Biomedical Research Center · Academic / Other
Sex
Female
Age
Healthy volunteers
Accepted

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 (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.

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 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSleep RestrictionWomen will be undergo 4 nights of sleep restriction.
BEHAVIORALHabitual SleepWomen will be undergo 4 nights of habitual sleep.

Timeline

Start date
2020-07-28
Primary completion
2022-04-13
Completion
2022-04-13
First posted
2020-02-27
Last updated
2022-11-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04286451. Inclusion in this directory is not an endorsement.