Gestational Diabetes
Conditions
Keywords
sleep duration, glucose metabolism
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.
Interventions
BEHAVIORALSleep extension
Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching
BEHAVIORALHealthy living
Participants will receive weekly health education
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Fasting Glucose | 6 weeks | Changes in fasting glucose between baseline and 6 weeks |
| Sleep Duration Change | baseline and 6 weeks | Changes in sleep duration from baseline to 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HOMA-IR Change | baseline 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 Quality | Baseline and week 6 | Pittsburgh sleep quality index (range 0 to 21 with higher score reflecting worse sleep quality) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sleep Intervention Sleep extension
Sleep extension: Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching | 12 |
| Healthy Living Health education
Healthy living: Participants will receive weekly health education | 6 |
| Total | 18 |
Baseline characteristics
| Characteristic | Sleep Intervention | Healthy Living | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 6 Participants | 18 Participants |
| Age, Continuous | 41.9 years STANDARD_DEVIATION 2.6 | 38.7 years STANDARD_DEVIATION 6 | 40.8 years STANDARD_DEVIATION 3.9 |
| fasting glucose | 102.3 mg/dL STANDARD_DEVIATION 12.9 | 96.4 mg/dL STANDARD_DEVIATION 3.8 | 100.2 mg/dL STANDARD_DEVIATION 10.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 12 participants | 6 participants | 15 participants |
| Sex: Female, Male Female | 12 Participants | 6 Participants | 18 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Sleep duration | 369 minutes STANDARD_DEVIATION 31 | 408 minutes STANDARD_DEVIATION 90 | 383 minutes STANDARD_DEVIATION 33 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 9 |
| other Total, other adverse events | 0 / 5 | 0 / 9 |
| serious Total, serious adverse events | 0 / 5 | 0 / 9 |
Outcome results
Primary
Changes in Fasting Glucose
Changes in fasting glucose between baseline and 6 weeks
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Living | Changes in Fasting Glucose | 10.4 mg/dL | Standard Deviation 8.2 |
| Sleep Intervention | Changes in Fasting Glucose | 1.6 mg/dL | Standard Deviation 9.4 |
Primary
Sleep Duration Change
Changes in sleep duration from baseline to 6 weeks
Time frame: baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Living | Sleep Duration Change | -9.1 minutes | Standard Deviation 20.4 |
| Sleep Intervention | Sleep Duration Change | 26.9 minutes | Standard Deviation 42.5 |
Secondary
Change in Subjective Sleep Quality
Pittsburgh sleep quality index (range 0 to 21 with higher score reflecting worse sleep quality)
Time frame: Baseline and week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Living | Change in Subjective Sleep Quality | -2.0 Score on a scale | Standard Deviation 4.2 |
| Sleep Intervention | Change in Subjective Sleep Quality | -2.8 Score on a scale | Standard Deviation 3.2 |
Secondary
HOMA-IR Change
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
Time frame: baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Living | HOMA-IR Change | 0.7 index | Standard Deviation 1.4 |
| Sleep Intervention | HOMA-IR Change | 0.59 index | Standard Deviation 1.08 |