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Sleep Duration in Women With Previous Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT03638102
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Sirimon Reutrakul, 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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Behavioral: Sleep extension Behavioral: Healthy living Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Sleep Extension on Glucose Metabolism in Women With Previous Diagnosis of Gestational Diabetes
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sleep intervention
Sleep extension
Behavioral: Sleep extension
Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching

Active Comparator: Healthy living
Health education
Behavioral: Healthy living
Participants will receive weekly health education




Primary Outcome Measures :
  1. Changes in Glucose metabolism parameters [ Time Frame: 6 weeks ]
    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

  2. Sleep duration [ Time Frame: 6 weeks ]
    Changes in sleep duration from baseline to 6 weeks


Secondary Outcome Measures :
  1. Glucose metabolism post intervention [ Time Frame: 10 weeks (4 weeks post intervention) ]
    Fasting glucose and insulin

  2. Energy metabolism post intervention [ Time Frame: 10 weeks (4 weeks post intervention) ]
    Weight and caloric intake

  3. Subjective sleep quality [ Time Frame: Baseline, week 6 and week 10 ]
    Pittsburgh sleep quality index (range 0 to 21 with higher score reflecting worse sleep quality)

  4. Energy metabolism [ Time Frame: 6 weeks ]
    Changes in weight, caloric intake, appetite, energy metabolism from baseline to 6 weeks

  5. Depressive symptoms [ Time Frame: Baseline, week 6 and week 10 ]
    Center for Epidemiologic Studies Depression Scale (range 0-60 with higher score reflecting more depressive symptoms)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Non-diabetic women with a previous history of gestational diabetes
Accepts Healthy Volunteers:   Yes
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 <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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638102


Contacts
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Contact: Sirimon Reutrakul 3124135357 sreutrak@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Sirimon Reutrakul, MD         
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Sirimon Reutrakul, MD University of Illinois at Chicago

Publications:

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Responsible Party: Sirimon Reutrakul, Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03638102     History of Changes
Other Study ID Numbers: 2018-0992
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sirimon Reutrakul, University of Illinois at Chicago:
sleep duration
glucose metabolism
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications