A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616171
• Other study ID #: IRB00105390
• Secondary ID: 5P30DK111024-02
• Status: Completed
• Phase: N/A
• Start date: August 30, 2017
• Est. completion date: April 2, 2018

Study information

• Verified date: December 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a prospective unblinded randomized trial to evaluate the feasibility of conducting a sleep extension intervention trial and the sleep extension intervention among the young adults. The study also wants to assess whether a sleep-extension intervention has an impact on the insulin resistance levels of young adults. The intervention consists of an education session and to extend the sleep time at least one hour but can be up to 2 hours per night for 4 weeks.

Description:

Insulin Resistance has been shown to put a person at risk for developing Type II diabetes. There is a correlation between sleep deprivation and insulin resistance.The study wants to assess the feasibility by enrolling 20 subjects in a year. The study also wants to assess the feasibility of the sleep extension intervention among young adults by examining the number of subjects that are randomized to intervention arm will complete the study.

Another intent of the study is to examine how sleep behaviors affect risks for developing type 2 diabetes and to determine their willingness to participate in a 4-week home-based program (intervention) focused on personal sleep behaviors.

Subjects enrolled in the study and are randomized to intervention group and control group. The intervention group will receive one education session consisting of strategies for sleep hygiene which is the routine for going to sleep and instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks. At the end of 4 weeks subjects will have a blood draw and will complete the questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• Age must be 18-25 years old

• Self-report short sleep

• BMI = 30 (the World Health Organization's classification of being obese)

• Insulin Resistance determined by serum analysis

• Be willing to extend time in bed by one hour total per night

• Read and speak English.

Exclusion Criteria:

• Night shift worker;

• Sleep disorder diagnosis;

• Medical diagnosis of diabetes or pre-diabetes;

• Currently pregnant or lactating or with history of gestational diabetes;

• Actively participating in a weight loss program;

• Hospitalization in past 3 months for any medical or psychiatric condition;

• Having a major chronic illness (e.g. cancer, Lupus)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• SLEEP-Extend intervention
One education session (5-10 minutes) consisting of strategies for sleep hygiene which is the routine for going to sleep Instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks which can be accomplished by either going to bed earlier or staying in bed later

Other:
• Control
Control group will receive 1. One educational session (5-10 minutes) consisting of safety practices used for an urban environment (a safety brochure and safety information will be given and reviewed with the subject)

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Georgia State University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Enrollments in the Study Over One Year	Feasibility of the study is assessed by number of enrollments in the study over a one year period. Study proposes to enroll minimum 20 subjects to meet the feasibility of the study.	Up to 12 months
Primary	Number of Participants Enrolled in the Intervention Arm Who Complete the Study	Feasibility of the SLEEP-Extend intervention among young adults is measured by number of participants enrolled in the intervention arm that received the intervention and completed the study required protocols for the study duration of 4 weeks.	Week 4
Secondary	Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores	The HOMA-IR score is used to measure severity of insulin resistance, though normal insulin resistance varies depending on the population. HOMA-IR is calculated as blood glucose level (nmol/L) multiplied by insulin level (microU/L), divided by 22.5. Elevated values indicate insulin resistance. A cutoff score of HOMA-IR < 2.1 is considered normal and HOMA-IR = 2.1 is considered to be evidence of insulin resistance.	Baseline, Week 4
Secondary	Hours of Sleep	Using wrist actigraphy, this study will objectively monitor each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.	Over a 1 week period at Baseline, and over a 1 week period at Week 4
Secondary	Number of Participants Extending Sleep	Sleep extension is assessed as the number of participants extending their nightly sleep by 1 to 2 hours from the baseline visit to the week 4 visit, as monitored using wrist actigraphy to measure each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.	Over a 1 week period at Baseline, and over a 1 week period at Week 4