Type 2 diabetes Type 2 Diabetes
Conditions
Interventions
Intervention Group
Subjects will receive a 12-week intervention to move their bedtime earlier than their baseline bedtimes.(The baselines are the bedtimes during the 2-week trial period.) The first we
Sponsors
Waki Kayo
Eligibility
Inclusion criteria
Inclusion criteria: (1) Diagnosed with type 2 diabetes and attending the hospital/clinic (2) HbA1c is 7.5% or higher at the time of obtaining consent (3) A short-sleeper - self-reports an average sleep duration in the prior month of 6 or fewer hours (4) In the contemplation, preparation, or action stage of the transtheoretical model (TTM) for the action of sleeping 7 hours or more per day (5) Willing and able to wear a wristband-type measuring device on the non-dominant wrist during the research period (6) Has and uses a mobile phone capable of sending and receiving SMS text messages (7) Able to attend consultations at designated times during the research period (8) 18 or older in age (9) Fluent in spoken and written Japanese (10) Does not have impaired cognitive function as determined by the investigator or sub investigator (11) Can undergo sleep treatment, as determined by the investigator or sub investigator (12) Fully informed about participation in this study, and has given free and voluntary written consent based on a thorough understanding of the study
Exclusion criteria
Exclusion criteria: (1) BMI is greater than 35.0 kg/m2 (2) Age is 76 years or older (3) A shift worker, or someone who sometimes sleeps in a way other than with a single major sleep period at night (4) A caregiver (of a child or adult) who needs to wake up during the night (5) At high risk of obstructive sleep apnea syndrome (OSA) (6) At high risk of possibility of insomnia (7) Possibility of restless legs syndrome (RLS) (8) High possibility of depression (9) Taking medications that affect sleep (10) Changed type 2 diabetes medication within the past 8 weeks (11) Currently participating in another clinical research program (12) A heavy user of alcohol (13) Has severe chronic pain (due to cancer, etc.) (14) Has a diagnosed clinical sleep disorder (15) Has an uncontrolled psychiatric disorder (16) Pregnant at the time of consent acquisition (17) Any other reason why the patient is classified as unfit for participation by the investigator or sub investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An analysis of covariance will be performed on the change in HbA1c from the time consent was obtained to the end of the intervention period (at 12 weeks), with HbA1c at the time consent was obtained as the covariate. Estimates and two-sided 95% confidence intervals for the mean of the change for each group will be calculated. Estimates and two-sided 95% confidence intervals for the difference between groups will also be calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| An analysis of covariance will be performed on the change from the time consent was obtained to the end of the intervention period (at 12 weeks) or the end of the observation period (at 24 weeks) for the following items, using the measurements at the time consent was obtained as covariates. Estimates and two-sided 95% confidence intervals for the mean of the change for each group will be calculated. Estimates and two-sided 95% confidence intervals for the difference between groups will also be calculated. 1.HbA1c (%) (only after the end of the observation period) 2. Body weight (kg) 3. BMI (kg/m2) 4. Systolic and diastolic blood pressure (mmHg) 5. eGFR (ml/min/1.73m2) 6. Fasting blood glucose (mg/dL) 7. LDL-C (mg/dL) 8. HDL-C (mg/dL) 9. Triglycerides (mg/dL) 10. UACR (mg/gCr) 11.PSQI-J | — |
Contacts
Public ContactYuki Ban
The University of Tokyo Hospital
Outcome results
None listed