Sleep Duration in Women With Previous Gestational Diabetes

NCT ID: NCT03638102

Last Updated: 2024-11-25

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-07-31

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.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sleep intervention

Sleep extension

Group Type EXPERIMENTAL

Sleep extension

Intervention Type BEHAVIORAL

Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching

Healthy living

Health education

Group Type ACTIVE_COMPARATOR

Healthy living

Intervention Type BEHAVIORAL

Participants will receive weekly health education

Interventions

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Sleep extension

Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching

Intervention Type BEHAVIORAL

Healthy living

Participants will receive weekly health education

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Sirimon Reutrakul

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sirimon Reutrakul, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Bellamy L, Casas JP, Hingorani AD, Williams D. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet. 2009 May 23;373(9677):1773-9. doi: 10.1016/S0140-6736(09)60731-5.

Reference Type BACKGROUND
PMID: 19465232 (View on PubMed)

Spiegel K, Leproult R, Van Cauter E. Impact of sleep debt on metabolic and endocrine function. Lancet. 1999 Oct 23;354(9188):1435-9. doi: 10.1016/S0140-6736(99)01376-8.

Reference Type BACKGROUND
PMID: 10543671 (View on PubMed)

Reutrakul S, Van Cauter E. Interactions between sleep, circadian function, and glucose metabolism: implications for risk and severity of diabetes. Ann N Y Acad Sci. 2014 Apr;1311:151-73. doi: 10.1111/nyas.12355. Epub 2014 Mar 14.

Reference Type BACKGROUND
PMID: 24628249 (View on PubMed)

Amnakkittikul S, Chirakalwasan N, Wanitcharoenkul E, Charoensri S, Saetung S, Chanprasertyothin S, Chailurkit LO, Panburana P, Bumrungphuet S, Reutrakul S. Postpartum resolution of obstructive sleep apnea in women with gestational diabetes and the relationship with glucose metabolism. Acta Diabetol. 2018 Jul;55(7):751-754. doi: 10.1007/s00592-018-1127-x. Epub 2018 Mar 15. No abstract available.

Reference Type BACKGROUND
PMID: 29546578 (View on PubMed)

Baron KG, Duffecy J, Reid K, Begale M, Caccamo L. Technology-Assisted Behavioral Intervention to Extend Sleep Duration: Development and Design of the Sleep Bunny Mobile App. JMIR Ment Health. 2018 Jan 10;5(1):e3. doi: 10.2196/mental.8634.

Reference Type BACKGROUND
PMID: 29321122 (View on PubMed)

Mohr DC, Duffecy J, Ho J, Kwasny M, Cai X, Burns MN, Begale M. A randomized controlled trial evaluating a manualized TeleCoaching protocol for improving adherence to a web-based intervention for the treatment of depression. PLoS One. 2013 Aug 21;8(8):e70086. doi: 10.1371/journal.pone.0070086. eCollection 2013.

Reference Type BACKGROUND
PMID: 23990896 (View on PubMed)

Reutrakul S, Martyn-Nemeth P, Quinn L, Rydzon B, Priyadarshini M, Danielson KK, Baron KG, Duffecy J. Effects of Sleep-Extend on glucose metabolism in women with a history of gestational diabetes: a pilot randomized trial. Pilot Feasibility Stud. 2022 Jun 4;8(1):119. doi: 10.1186/s40814-022-01076-2.

Reference Type DERIVED
PMID: 35659776 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2018-0992

Identifier Type: -

Identifier Source: org_study_id

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