Status:
COMPLETED
Personalizing Sleep Interventions to Prevent Type 2 Diabetes in Community Dwelling Adults With Pre-Diabetes
Lead Sponsor:
New York University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
PreDiabetes
Eligibility:
All Genders
21-64 years
Phase:
NA
Brief 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-restric...
Detailed 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, onl...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- type 2 diabetes (Hemoglobin A1C greater than or equal to 6.5%)
- pregnancy or lactation (self-report)
- hemophilia (self-report)
- moderate/severe or severe depression (PHRQ greater than or equal to 15))
- 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)
- 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).
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2023
Estimated Enrollment :
393 Patients enrolled
Trial Details
Trial ID
NCT03398902
Start Date
March 15 2021
End Date
September 18 2023
Last Update
September 4 2025
Active Locations (1)
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1
NYU Langone
New York, New York, United States, 10010