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

NCT04286451 | Completed

• 1 other identifier: PBRC 2020-007
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Sleep Disturbance; Postmenopausal Symptoms; Insulin Sensitivity; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• 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.

  4 days

Secondary Outcomes (9)

• Adipose tissue insulin sensitivity (via free fatty acid area-under-the-curve during the low-dose clamp) (in vivo)

  4 days

• Insulin-dependent suppression of lipolysis (via ex vivo adipose tissue biopsy analyses)

  4 days

• Fat oxidation and substrate switching (via ex vivo skeletal muscle biopsy analyses)

  4 days

• Insulin sensitivity (via ex vivo skeletal muscle biopsy analyses)

  4 days

• Gene expression (via ex vivo skeletal muscle biopsy analyses with RNASeq and RT-PCR)

  4 days

Study Arms (2)

Sleep Restriction

EXPERIMENTAL

Women will undergo 4 nights of sleep restriction treatment.

Behavioral: Sleep Restriction

Habitual Sleep

EXPERIMENTAL

Women will undergo 4 nights of habitual sleep treatment.

Behavioral: Habitual Sleep

Interventions

Sleep Restriction BEHAVIORAL

Women will be undergo 4 nights of sleep restriction.

Sleep Restriction

Habitual Sleep BEHAVIORAL

Women will be undergo 4 nights of habitual sleep.

Habitual Sleep

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• Singh P, Beyl RA, Stephens JM, Noland RC, Richard AJ, Boudreau A, Hebert RC, Ravussin E, Broussard JL, St-Onge MP, Marlatt KL. Effect of sleep restriction on insulin sensitivity and energy metabolism in postmenopausal women: A randomized crossover trial. Obesity (Silver Spring). 2023 May;31(5):1204-1215. doi: 10.1002/oby.23739. Epub 2023 Mar 30.

  PMID: 36998155 DERIVED

MeSH Terms

Conditions

Parasomnias; Insulin Resistance

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kara L Marlatt, PhD, MPH

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: February 27, 2020
• Study Start: July 28, 2020
• Primary Completion: April 13, 2022
• Study Completion: April 13, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

US (1)