Evaluation of the effectiveness of the orexin receptor antagonist (Suvorexant) for type 2 diabetes with untreated sleep disorder.
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-UMIN000023827
- Lead Sponsor
- Toho University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
(1)Type 1 diabetes mellitus patients or secondary diabetic mellitus (2)Patients taking a sleeping drugs or antipsychotic within one year. (3) Patients who had myocardial infarction within 3 months, or obvious heart failure case (4) Patients with diabetic ketoacidosis or diabetic coma or risk of diabetic coma (5) Patients with severe liver disease (6) Patients with severe renal disease (7) Patients with severe pancreas disease (8) Patients with severe diabetic neuropathy (9) Patients having a proliferative retinopathy (10) Patients with a serious infectious disease or a serious injury (11) Excessive common custom drinker (12) A pregnant woman or the woman who may be pregnant (13) In addition, the patients who will be judged inappropriate by an attendant physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes of validation by continuas glcose monitor (CGM) 16 weeks later.
- Secondary Outcome Measures
Name Time Method (1)changes of quality of life(QOL),questionnaire about the sleep,and dietary intake 16 weeks later. (2)a reduction degree of HbA1c,GA and fasting blood prasma glucose 16 weeks later. (3)a reduction degree of lipid parameters(HDL cholesterol,LDL cholesterol,triglyceride)and albumin in urine 16 weeks later. (4)changes of blood or urine hormone level 16 weeks later. (5)changes of body weight,blood pressure,abdominal circumscription,and body composition 16 weeks later.