Demo study for EDU

  • STATUS
    Recruiting
  • participants needed
    40
Updated on 17 April 2023

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.

Details
Condition Diabetes Mellitus Types I and II
Age 10years - 90years
Clinical Study IdentifierTX13071
Last Modified on17 April 2023

Eligibility

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
0 0 /250
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.