Double-blind randomized cross-over trial to assess the efficacy and safety of subcutaneous ghrelin in diabetic patients with cardiac autonomic dysfunctio
Not Applicable
Recruiting
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-UMIN000008386
- Lead Sponsor
- ational Cerebral and Cardiovascular Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
Not provided
Exclusion Criteria
1. recent acute cardiovascular or cerebrovascular event 2. severe cardiac dysfunction 3. severe pulmonary dysfunction 4. active hepatitis or cirrhosis 5. severe kidney dysfuntion 6. severely impaired glucose control 7. untreated retinopathy 8. active infection 9. pregnancy 10. severe neuropathy 11. malignancy 12. severe arrhythmia 13. other reasons decided by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Safety 2. Changes in autonomic function indices by heart rate variability using power spectrum analysis
- Secondary Outcome Measures
Name Time Method