Sleep Duration in Women With Previous Gestational Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Sleep Extension on Glucose Metabolism in Women With Previous Diagnosis of Gestational Diabetes

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Behavioral: Sleep extension
* Behavioral: Healthy living


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep intervention<br>Sleep extension | Behavioral: Sleep extension<br>* Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching<br>|
| Active Comparator: Healthy living<br>Health education | Behavioral: Healthy living<br>* Participants will receive weekly health education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Glucose metabolism parameters | Changes in serum glucose and insulin levels from oral glucose tolerant test (at 0,30,60,90 and 120 minutes) between baseline and 6 weeks | 6 weeks | 
| Sleep duration | Changes in sleep duration from baseline to 6 weeks | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose metabolism post intervention | Fasting glucose and insulin | 10 weeks (4 weeks post intervention) | 
| Energy metabolism post intervention | Weight and caloric intake | 10 weeks (4 weeks post intervention) | 
| Subjective sleep quality | Pittsburgh sleep quality index (range 0 to 21 with higher score reflecting worse sleep quality) | Baseline, week 6 and week 10 | 
| Energy metabolism | Changes in weight, caloric intake, appetite, energy metabolism from baseline to 6 weeks | 6 weeks | 
| Depressive symptoms | Center for Epidemiologic Studies Depression Scale (range 0-60 with higher score reflecting more depressive symptoms) | Baseline, week 6 and week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep duration, glucose metabolism