Diabetes Mellitus, Type 2
Conditions
Keywords
Sleep Behavior, Insulin resistance
Brief 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.
Detailed 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.
Interventions
BEHAVIORALSLEEP-Extend intervention
1. One education session (5-10 minutes) consisting of strategies for sleep hygiene which is the routine for going to sleep 2. 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
OTHERControl
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)
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective, randomized and unblinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Enrollments in the Study Over One Year | Up to 12 months | 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. |
| Number of Participants Enrolled in the Intervention Arm Who Complete the Study | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores | Baseline, Week 4 | 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. |
| Hours of Sleep | Over a 1 week period at Baseline, and over a 1 week period at Week 4 | 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. |
| Number of Participants Extending Sleep | Over a 1 week period at Baseline, and over a 1 week period at Week 4 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled between August 30, 2017 and April 2, 2018 from Georgia State University in Atlanta, Georgia.
Pre-assignment details
A total of 19 individuals consented to take part in the study, of which 13 did not meet eligibility criteria during the screening process, resulting in 6 participants who were randomized to a study arm.
Participants by arm
| Arm | Count |
|---|---|
| SLEEP-Extend Intervention Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour. | 4 |
| Control Group Participants receiving one educational session consisting of safety practices used for an urban environment. | 2 |
| Total | 6 |
Baseline characteristics
| Characteristic | SLEEP-Extend Intervention | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 19 years STANDARD_DEVIATION 0.82 | 19.83 years STANDARD_DEVIATION 2.64 | 21.5 years STANDARD_DEVIATION 4.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Married | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Other | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Single | 4 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Persian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United States | 4 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 2 |
| other Total, other adverse events | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 |
Outcome results
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.
Time frame: Up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SLEEP-Extend Intervention | Number of Enrollments in the Study Over One Year | 4 Participants |
| Control Group | Number of Enrollments in the Study Over One Year | 2 Participants |
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.
Time frame: Week 4
Population: Only participants in the intervention arm are included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SLEEP-Extend Intervention | Number of Participants Enrolled in the Intervention Arm Who Complete the Study | 4 Participants |
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.
Time frame: Baseline, Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SLEEP-Extend Intervention | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores | Baseline | 5.73 HOMA-IR score | Standard Deviation 3.81 |
| SLEEP-Extend Intervention | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores | Week 4 | 6.55 HOMA-IR score | Standard Deviation 5.47 |
| Control Group | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores | Baseline | 4.33 HOMA-IR score | Standard Deviation 0.94 |
| Control Group | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores | Week 4 | 5.13 HOMA-IR score | Standard Deviation 1.54 |
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.
Time frame: Over a 1 week period at Baseline, and over a 1 week period at Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SLEEP-Extend Intervention | Hours of Sleep | Baseline | 5.18 hours | Standard Deviation 0.55 |
| SLEEP-Extend Intervention | Hours of Sleep | Week 4 | 5.63 hours | Standard Deviation 0.92 |
| Control Group | Hours of Sleep | Baseline | 5.78 hours | Standard Deviation 0.01 |
| Control Group | Hours of Sleep | Week 4 | 6.72 hours | Standard Deviation 0.41 |
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.
Time frame: Over a 1 week period at Baseline, and over a 1 week period at Week 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SLEEP-Extend Intervention | Number of Participants Extending Sleep | 2 Participants |
| Control Group | Number of Participants Extending Sleep | 1 Participants |