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

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ClinicalTrials.gov Identifier: NCT03398902
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Susan Malone, New York University

Study Description
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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.

Condition or disease Intervention/treatment Phase
PreDiabetes Behavioral: Sleep extension Other: Habitual sleep Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Personalizing Sleep Interventions to Prevent Type 2 Diabetes in Community Dwelling Adults With Pre-Diabetes
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sleep extension
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.
 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.
Active Comparator: Habitual sleep
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in % time glucose is ≥ 140mg/dL [ Time Frame: baseline and week 12 ]
    measured with continuous glucose monitoring


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398902


Contacts
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Contact: Susan K Malone, PhD 732 693-8081 sm7760@nyu.edu

Locations
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United States, New York
NYU Langone Recruiting
New York, New York, United States, 10010
Contact: Susan K Malone, PhD    212-992-7047    sm7760@nyu.edu   
Sponsors and Collaborators
New York University
Investigators
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Principal Investigator: Susan K Malone, PhD New York University
More Information
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Publications:

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Responsible Party: Susan Malone, Senior Research Scientist, New York University
ClinicalTrials.gov Identifier: NCT03398902    
Other Study ID Numbers: R00NR017416 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
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).
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.
URL: http://www.sleepdata.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susan Malone, New York University:
sleep
sleep extension
sleep patterns
type 2 diabetes
 glucose regulation
behavioral intervention
adults
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Prediabetic State
Diabetes Mellitus
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases