Gestational DiabetesNCT03638102
Sleep Duration in Women With Previous Gestational Diabetes
A study testing Sleep extension and Healthy living in people with Gestational Diabetes, run by University of Illinois Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Sleep extension and Healthy living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: 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.
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- Sleep extension, Healthy living
- Keywords
- sleep duration, glucose metabolism
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep extensionBehavioural
Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching
Healthy livingBehavioural
Participants will receive weekly health education
| Study group | Role | What they receive |
|---|---|---|
| Sleep intervention | Experimental | Sleep extension Receives: Behavioral: Sleep extension |
| Healthy living | Active comparator | Health education Receives: Behavioral: Healthy living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fasting Glucose
Changes in fasting glucose between baseline and 6 weeks
Measured: 6 weeks
Sleep Duration Change
Changes in sleep duration from baseline to 6 weeks
Measured: baseline and 6 weeks
Secondary outcomes (2)
HOMA-IR Change
HOMA-IR change at week 0 to week 6. This is an index of fasting insulin resistance, and the higher reflects greater insulin resistance. Generally, a value greater than 2 is suggestive of insulin resistance
Measured: baseline and 6 weeks
Change in Subjective Sleep Quality
Pittsburgh sleep quality index (range 0 to 21 with higher score reflecting worse sleep quality)
Measured: Baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Feb 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirimon Reutrakul, University of Illinois Chicago
- Investigators
- Sirimon Reutrakul, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638102
- Sponsor's protocol ID
- 2018-0992
- Status last verified
- Nov 2024
- First submitted
- 12 Aug 2018
- Last updated
- 25 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19465232Spiegel 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.
PubMed 10543671Reutrakul 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.
PubMed 24628249Amnakkittikul 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.
PubMed 29546578Baron 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.
PubMed 29321122Mohr 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.
PubMed 23990896Reutrakul 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.
PubMed 35659776
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep Extension on Glucose Metabolism in Women With Previous Diagnosis of Gestational Diabetes
- ClinicalTrials.gov ID
- NCT03638102
- Acronym / sponsor ID
- 2018-0992
- Conditions
- Gestational Diabetes
- Keywords
- sleep duration, glucose metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Posted 25 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep intervention | Experimental | Behavioral: Sleep extensionSleep extension |
| Healthy living | Active comparator | Behavioral: Healthy livingHealth education |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep extensionSleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching | Behavioural | Sleep intervention |
| Healthy livingParticipants will receive weekly health education | Behavioural | Healthy living |
Primary outcome
Changes in Fasting Glucose
Time frame: 6 weeks
Changes in fasting glucose between baseline and 6 weeks
Sleep Duration Change
Time frame: baseline and 6 weeks
Changes in sleep duration from baseline to 6 weeks
2 secondary outcomes
HOMA-IR Change
Time frame: baseline and 6 weeks
Change in Subjective Sleep Quality
Time frame: Baseline and week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19465232Bellamy 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.
- Background: PubMed 10543671Spiegel 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.
- Background: PubMed 24628249Reutrakul 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.
- Background: PubMed 29546578Amnakkittikul 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.
- Background: PubMed 29321122Baron 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.
- Background: PubMed 23990896Mohr 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.
- Derived from this study: PubMed 35659776Reutrakul 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirimon Reutrakul, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep extension and Healthy living in people with Gestational Diabetes, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fasting Glucose (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03638102, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.