Strategic Trial for the Prevention of Progression of Overt Diabetic Kidney Disease by GLP-1receptor agonists and SGLT2 inhibitors in Okinawa
- Conditions
- Diabetice
- Registration Number
- JPRN-UMIN000031651
- Lead Sponsor
- Sunagawa Medical Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Not provided
1. Diabetes with complications requiring hospitalization such as diabetic ketoacidosis 2. Severe heart failure, severe arrhythmia, angina pectoris, myocardial infarction, stroke developed within 6 months before the start of the study 3. Pregnant women or patients who may be pregnant and breast-feeding patients 4. Ingestion of SGLT2 inhibitor 5. Have a history of having serious side effects with GLP-1 receptor agonist and SGLT2 inhibitor 6. Patients who had positive urinary occult blood test at least twice within 6 months 7. Patients with malignant tumor complications 8. Patients complicated of mental illness without self-determination ability 9. Other patients judged inappropriate by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method After 12 months starting administration of decrease rate of estimated glomerular filtration rate (%DeGFR)
- Secondary Outcome Measures
Name Time Method After 12 months starting administration of 0.Decrease amount of estimated glomerular filtration rate (DeGFR) 1.Changes in quantitative determination of urinary albumin 2.Changes in urine protein quantification 3.Change in HbA1c value 4.Change in weight 5.Frequency of hypoglycemia 6.Cardiovascular events: acute myocardial infarction, cerebral infarction (excluding lacunar infarction) 7.Renal event: Introduction of dialysis 8.Total death 9.Change in LDL-C value 10.Change in Non-HDL value 11.Change in TG value 12.Change in HDL-C value 13.Change in dynamic quantity evaluation 14.Change in intestinal flora 15.Changes in body composition