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Sleep Duration in Women With Previous Gestational Diabetes

Not Applicable
Completed
Conditions
Gestational Diabetes
Interventions
Behavioral: Sleep extension
Behavioral: Healthy living
Registration Number
NCT03638102
Lead Sponsor
University of Illinois at Chicago
Brief Summary

Women with a history of gestational diabetes (GDM) are at high risk of developing diabetes in the future. Sleep disturbances are emerging as risk factors for incident diabetes. The purpose of this study is to test the effects of 6-week sleep extension in women with a history of GDM and short sleep on glucose metabolism by randomized controlled study.

Detailed Description

The primary aim of this study is to evaluate the effects of a sleep extension intervention in non-diabetic women with a prior history of GDM and habitual short sleep duration on the outcomes of glucose metabolism. The participants will be randomized to a 6-week sleep extension intervention group, using technology-assisted sleep intervention, or a healthy living information control group. Glucose metabolism parameters will be assessed by an oral glucose tolerant test.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
18
Inclusion Criteria
  • Premenopausal women, age 18-45, with a history of GDM who currently do not have diabetes
  • At least one year post-partum
  • Reported habitual sleep duration <7h/night during work- or weekdays with a desire to sleep longer
  • Reported time spent in bed =<8 hours
  • Own a smartphone compatible with Fitbit.
  • No need to provide care at night for her child(ren), defined as >3 times a week and >30 minutes at a time
  • No history of obstructive sleep apnea, insomnia, or restless leg syndrome
Exclusion Criteria
  • A1C ≥6.5%
  • Currently pregnant or planning pregnancy or breast feeding
  • Insomnia symptoms defined as severe as assessed by the Insomnia Severity Index (score ≥15)
  • Rotating shift or night shift work
  • High risk for obstructive sleep apnea screened by STOP BANG questionnaire.
  • Significant medical morbidities, such as congestive heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer or psychiatric problem, history of stroke with neurological deficits, cognitive impairment, kidney failure requiring dialysis, illicit drug use.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sleep interventionSleep extensionSleep extension
Healthy livingHealthy livingHealth education
Primary Outcome Measures
NameTimeMethod
Changes in Fasting Glucose6 weeks

Changes in fasting glucose between baseline and 6 weeks

Sleep Duration Changebaseline and 6 weeks

Changes in sleep duration from baseline to 6 weeks

Secondary Outcome Measures
NameTimeMethod
HOMA-IR Changebaseline and 6 weeks

HOMA-IR change at week 0 to week 6. This is an index of fasting insulin resistance, and the higher reflects greater insulin resistance. Generally, a value greater than 2 is suggestive of insulin resistance

Change in Subjective Sleep QualityBaseline and week 6

Pittsburgh sleep quality index (range 0 to 21 with higher score reflecting worse sleep quality)

Trial Locations

Locations (1)

University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

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