Personalizing Sleep Interventions to Prevent Type 2 Diabetes in Community Dwelling Adults With Pre-Diabetes

PreDiabetes Clinical Trial

Official title:

Personalizing Sleep Interventions to Prevent Type 2 Diabetes in Community Dwelling Adults With Pre-Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03398902
• Other study ID #: R00NR017416
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: New York University
• Contact: Susan K Malone, PhD
• Phone: 732 693-8081
• Email: sm7760[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will use continuous glucose monitoring and actigraphy to examine whether a personalized, daily sleep extension intervention improves glucose regulation for community dwelling, sleep-restricted adults with pre-diabetes. The randomized controlled trial will include 150 adults with pre-diabetes. Sleep extension and habitual sleep groups will complete daily sleep diaries and participate in a weekly 15-minute telephone call or videoconference meeting with a member of the study team (8 sessions total). Data collection will be at 2 time points: pre-randomization and post-intervention (completion of the 8-week intervention). Changes in the percent time glucose is ≥ 140mg/dL at baseline and post-intervention will be established and compared across the sleep extension and habitual sleep arms.

Description:

Diet and exercise interventions have made great strides in preventing and delaying type 2 diabetes (T2D) onset: benefits that surpass pharmacological interventions in some people. Disappointingly, only half the amount of weight loss and wide ranges in T2D risk reduction have been reported when translating these programs into community settings using less intense, more affordable interventions. Low program participation rates, underscored by reports that only 50% of Americans with prediabetes attempt lifestyle modifications, suggest that approaches focused on calorie restriction and physical activity are only effective for select, highly motivated individuals. Expanding success for heretofore resistant groups and optimizing long term maintenance requires novel approaches beyond diet and exercise. One novel approach is improving sleep. Associations between sleep duration, sleep patterns, and glucose regulation in healthy adults suggest that interventions targeting these dimensions of sleep will improve glucose regulation. Improved insulin sensitivity has been reported in a small community based daily sleep extension study (N= 16), as well as in a 2-day lab based sleep extension study using a personalized "catch up" sleep intervention in healthy adults (N = 19,). Limited by small sample sizes, controlled lab conditions, and the exclusion of persons at greatest risk for T2D, the role of sleep in mitigating T2D risk remains uncertain. Moreover, sleep extension interventions have applied a generic approach to extending sleep despite variability in individual sleep need. The sleep extension intervention in this study will address how to extend sleep based on individual responses to the intervention. This study will test the effects of a personalized daily sleep extension intervention versus habitual sleep patterns on the percentage of time glucose is 140 mg/dL in sleep restricted community-dwelling adults at high risk for T2D. Wearable sensor technologies (continuous glucose monitoring and accelerometry) will be used. This study will inform person-specific sleep interventions that improve glycemic responses, thus providing treatment for the pre-diabetic state. Hypothesis: Personalized daily sleep extension will result in a lower % time glucose is ≥ 140 compared to habitual sleep after 8 weeks of treatment initiation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Glycated hemoglobin (Hemoglobin A1C) greater than or equal to 5.7% and less than 6.5%.
• Restricted sleep defined as less than 6.5 hours average work day sleep (actigraphy confirmed).
• employed greater than or equal to 20 hours of work per week (self report).

Exclusion Criteria:

• type 2 diabetes (Hemoglobin A1C greater than or equal to 6.5%)
• pregnancy or lactation (self-report)
• hemophilia (self-report)
• obstructive sleep apnea (Multivariable Apnea Prediction Index > 0.50 or Home sleep apnea test Apnea-Hypopnea Index >10 events/hour).
• insomnia (Insomnia Severity Index greater than 10)
• moderate/severe or severe depression (PROMIS-D-short form raw score greater than or equal to 27 or T-score greater than or equal to 64.7)
• alcohol abuse/dependence (Alcohol Use Disorders Identification Test greater than or equal to 10).
• sleep promoting medications (self-report)
• hypoglycemic agents (except metformin) (self-report) --current chemotherapy treatments (self-report)
• extended napping (greater than or equal to 2 naps per day or greater than 90 minutes naps per day on 3 or more days of the week) (actigraphy-confirmed).
• Shift work during the past 2 months or planned during intervention period (self-report).
• Trans-meridian travel in the past 4 weeks or planned during intervention period (self-report).
• No difference between work day and free day sleep duration (actigraphy confirmed).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Sleep extension
Based on CBTI principles, the instructor will prescribe bed times and wake times each week to allow for gradual increases in sleep opportunity.

Other:
• Habitual sleep
The study team member will monitor and encourage participants to keep bedtimes and wake times that matched their baseline bedtimes and wake times.

Locations

Country	Name	City	State
United States	NYU Langone	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University

Country where clinical trial is conducted

United States, 

References & Publications (16)

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Holliday EG, Magee CA, Kritharides L, Banks E, Attia J. Short sleep duration is associated with risk of future diabetes but not cardiovascular disease: a prospective study and meta-analysis. PLoS One. 2013 Nov 25;8(11):e82305. doi: 10.1371/journal.pone.0082305. eCollection 2013. — View Citation

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Leproult R, Deliens G, Gilson M, Peigneux P. Beneficial impact of sleep extension on fasting insulin sensitivity in adults with habitual sleep restriction. Sleep. 2015 May 1;38(5):707-15. doi: 10.5665/sleep.4660. — View Citation

Linmans JJ, Spigt MG, Deneer L, Lucas AE, de Bakker M, Gidding LG, Linssen R, Knottnerus JA. Effect of lifestyle intervention for people with diabetes or prediabetes in real-world primary care: propensity score analysis. BMC Fam Pract. 2011 Sep 13;12:95. doi: 10.1186/1471-2296-12-95. — View Citation

Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. — View Citation

Perreault L, Temprosa M, Mather KJ, Horton E, Kitabchi A, Larkin M, Montez MG, Thayer D, Orchard TJ, Hamman RF, Goldberg RB; Diabetes Prevention Program Research Group. Regression from prediabetes to normal glucose regulation is associated with reduction in cardiovascular risk: results from the Diabetes Prevention Program outcomes study. Diabetes Care. 2014 Sep;37(9):2622-31. doi: 10.2337/dc14-0656. Epub 2014 Jun 26. — View Citation

Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006 Feb;49(2):289-97. Epub 2006 Jan 4. — View Citation

Schellenberg ES, Dryden DM, Vandermeer B, Ha C, Korownyk C. Lifestyle interventions for patients with and at risk for type 2 diabetes: a systematic review and meta-analysis. Ann Intern Med. 2013 Oct 15;159(8):543-51. doi: 10.7326/0003-4819-159-8-201310150-00007. Review. — View Citation

Tuomilehto J, Lindström J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P, Keinänen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. — View Citation

Yoon U, Kwok LL, Magkidis A. Efficacy of lifestyle interventions in reducing diabetes incidence in patients with impaired glucose tolerance: a systematic review of randomized controlled trials. Metabolism. 2013 Feb;62(2):303-14. doi: 10.1016/j.metabol.2012.07.009. Epub 2012 Sep 7. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in % time glucose is = 140mg/dL	measured with continuous glucose monitoring	baseline and week 12