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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep intervention | Experimental | Sleep extension |
|
| Healthy living | Active Comparator | Health education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep extension | Behavioral | Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fasting Glucose | Changes in fasting glucose between baseline and 6 weeks | 6 weeks |
| Sleep Duration Change | Changes in sleep duration from baseline to 6 weeks | baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and 6 weeks |
| Change in Subjective Sleep Quality |
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Inclusion Criteria:
Exclusion Criteria:
Non-diabetic women with a previous history of gestational diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Sirimon Reutrakul, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19465232 | Background | 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. | |
| 10543671 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sleep Intervention | Sleep extension Sleep extension: Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching |
| FG001 | Healthy Living | Health education Healthy living: Participants will receive weekly health education |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sleep Intervention | Sleep extension Sleep extension: Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching |
| BG001 | Healthy Living | Health education Healthy living: Participants will receive weekly health education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Fasting Glucose | Changes in fasting glucose between baseline and 6 weeks | Posted | Mean | Standard Deviation | mg/dL | 6 weeks |
|
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Living | Health education Healthy living: Participants will receive weekly health education |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sirimon Reutrakul | University of Illinois Chicago | 3124135357 | sreutrak@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2020 | Aug 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| Healthy living | Behavioral | Participants will receive weekly health education |
|
Pittsburgh sleep quality index (range 0 to 21 with higher score reflecting worse sleep quality) |
| Baseline and week 6 |
| 24628249 | Background | 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. |
| 29546578 | Background | 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. |
| 29321122 | Background | 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. |
| 23990896 | Background | 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. |
| 35659776 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sleep duration | one person dropped out | Mean | Standard Deviation | minutes |
|
| fasting glucose | one person dropped out | Mean | Standard Deviation | mg/dL |
|
| Participants |
|
|
| Primary | Sleep Duration Change | Changes in sleep duration from baseline to 6 weeks | Posted | Mean | Standard Deviation | minutes | baseline and 6 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | index | baseline and 6 weeks |
|
|
|
| Secondary | Change in Subjective Sleep Quality | Pittsburgh sleep quality index (range 0 to 21 with higher score reflecting worse sleep quality) | Posted | Mean | Standard Deviation | Score on a scale | Baseline and week 6 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Sleep Intervention | Sleep extension Sleep extension: Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching | 0 | 9 | 0 | 9 | 0 | 9 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |