Sleep Duration in Women With Previous Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638102
• Other study ID #: 2018-0992
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: September 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 metabolism by randomized controlled study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• Sleep extension
Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching
• Healthy living
Participants will receive weekly health education

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Spiegel K, Leproult R, Van Cauter E. Impact of sleep debt on metabolic and endocrine function. Lancet. 1999 Oct 23;354(9188):1435-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Glucose metabolism parameters	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
Primary	Sleep duration	Changes in sleep duration from baseline to 6 weeks	6 weeks
Secondary	Glucose metabolism post intervention	Fasting glucose and insulin	10 weeks (4 weeks post intervention)
Secondary	Energy metabolism post intervention	Weight and caloric intake	10 weeks (4 weeks post intervention)
Secondary	Subjective sleep quality	Pittsburgh sleep quality index (range 0 to 21 with higher score reflecting worse sleep quality)	Baseline, week 6 and week 10
Secondary	Energy metabolism	Changes in weight, caloric intake, appetite, energy metabolism from baseline to 6 weeks	6 weeks
Secondary	Depressive symptoms	Center for Epidemiologic Studies Depression Scale (range 0-60 with higher score reflecting more depressive symptoms)	Baseline, week 6 and week 10