The Effect of Sleep Extension on Glucose Metabolism in Women With Previous Diagnosis of Gestational Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Changes in Fasting Glucose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Sleep intervention
Sleep extension
Intervention: Sleep extension (Behavioral)
Healthy living
Health education
Intervention: Healthy living (Behavioral)
Outcomes
Primary Outcomes
Changes in Fasting Glucose
Time Frame: 6 weeks
Changes in fasting glucose between baseline and 6 weeks
Sleep Duration Change
Time Frame: baseline and 6 weeks
Changes in sleep duration from baseline to 6 weeks
Secondary Outcomes
- HOMA-IR Change(baseline and 6 weeks)
- Change in Subjective Sleep Quality(Baseline and week 6)
Investigators
Sirimon Reutrakul
Associate Professor
University of Illinois at Chicago