N/A
N=18
Sleep Duration in Women With Previous Gestational Diabetes
Gestational Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03638102 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Changes in Fasting Glucose — 10.4; 1.6 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleep extension (Behavioral); Healthy living (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Fasting Glucose |
10.4; 1.6 | — |
| PRIMARY Sleep Duration Change |
-9.1; 26.9 | — |
| SECONDARY HOMA-IR Change |
0.7; 0.59 | — |
| SECONDARY Change in Subjective Sleep Quality |
-2.0; -2.8 | — |
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT03638102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.