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

Primary Purpose

PreDiabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep extension
Habitual sleep
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring sleep, sleep extension, sleep patterns, type 2 diabetes, glucose regulation, behavioral intervention, adults

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • NYU LangoneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sleep extension

Habitual sleep

Arm Description

Participants in the sleep extension group will keep daily sleep diaries. Sleep diaries will be reviewed with the participant and an instructor trained in Cognitive Behavioral Therapy for Insomnia (CBTI) on a weekly basis. These weekly sessions will take place by telephone or videoconferencing.

Participants in the habitual sleep group will be instructed to keep their habitual bedtimes and wake times. Participants will keep daily sleep diaries that will we reviewed by a study team member each week. These weekly sessions will take place by telephone or videoconferencing.

Outcomes

Primary Outcome Measures

Change in % time glucose is ≥ 140mg/dL
measured with continuous glucose monitoring

Secondary Outcome Measures

Full Information

First Posted
January 5, 2018
Last Updated
November 4, 2022
Sponsor
New York University
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1. Study Identification

Unique Protocol Identification Number
NCT03398902
Brief Title
Personalizing Sleep Interventions to Prevent Type 2 Diabetes in Community Dwelling Adults With Pre-Diabetes
Official Title
Personalizing Sleep Interventions to Prevent Type 2 Diabetes in Community Dwelling Adults With Pre-Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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-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.
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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
sleep, sleep extension, sleep patterns, type 2 diabetes, glucose regulation, behavioral intervention, adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep extension
Arm Type
Experimental
Arm Description
Participants in the sleep extension group will keep daily sleep diaries. Sleep diaries will be reviewed with the participant and an instructor trained in Cognitive Behavioral Therapy for Insomnia (CBTI) on a weekly basis. These weekly sessions will take place by telephone or videoconferencing.
Arm Title
Habitual sleep
Arm Type
Active Comparator
Arm Description
Participants in the habitual sleep group will be instructed to keep their habitual bedtimes and wake times. Participants will keep daily sleep diaries that will we reviewed by a study team member each week. These weekly sessions will take place by telephone or videoconferencing.
Intervention Type
Behavioral
Intervention Name(s)
Sleep extension
Intervention Description
Based on CBTI principles, the instructor will prescribe bed times and wake times each week to allow for gradual increases in sleep opportunity.
Intervention Type
Other
Intervention Name(s)
Habitual sleep
Intervention Description
The study team member will monitor and encourage participants to keep bedtimes and wake times that matched their baseline bedtimes and wake times.
Primary Outcome Measure Information:
Title
Change in % time glucose is ≥ 140mg/dL
Description
measured with continuous glucose monitoring
Time Frame
baseline and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan K Malone, PhD
Phone
732 693-8081
Email
sm7760@nyu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan K Malone, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan K Malone, PhD
Phone
212-992-7047
Email
sm7760@nyu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators are committed to the principles that NIH has articulated regarding the sharing of study results and resources. The Investigators will make unique research resources readily available for research purposes to individuals within the scientific community after publication. The privacy and rights of participants in the research study will be protected by redacting all identifiers and adopting strategies to minimize the risk of unauthorized disclosure of identifiers in accordance with the data security plan and the participant's Institutional Review Board (IRB)-approved informed consent. The consent language for the R00 study will be worded for possible broad data sharing. Sharing Model Organisms Not Applicable Genome Wide Association Studies Not Applicable
IPD Sharing Time Frame
The timeline for submission to an NIH-designated data repository will allow first for publication of findings related to the aims of the R00 study, as well as submission of findings as preliminary data for anticipated grant application(s).
IPD Sharing Access Criteria
After data collection is complete, the investigators plan to make the full dataset (redacted of all identifying information) available through the National Sleep Research Resource.
IPD Sharing URL
http://www.sleepdata.org
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Personalizing Sleep Interventions to Prevent Type 2 Diabetes in Community Dwelling Adults With Pre-Diabetes

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