Sleep Duration in Women With Previous Gestational Diabetes

September 27, 2021 updated by: Sirimon Reutrakul, University of Illinois at Chicago

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks
Sleep duration
Time Frame: 6 weeks
Changes in sleep duration from baseline to 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose metabolism post intervention
Time Frame: 10 weeks (4 weeks post intervention)
Fasting glucose and insulin
10 weeks (4 weeks post intervention)
Energy metabolism post intervention
Time Frame: 10 weeks (4 weeks post intervention)
Weight and caloric intake
10 weeks (4 weeks post intervention)
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)
Baseline, week 6 and week 10
Energy metabolism
Time Frame: 6 weeks
Changes in weight, caloric intake, appetite, energy metabolism from baseline to 6 weeks
6 weeks
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)
Baseline, week 6 and week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Investigators

  • Principal Investigator: Sirimon Reutrakul, MD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

August 12, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (Actual)

August 20, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0992

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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