Diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clearly diagnosed with type 2 diabetes mellitus (T2DM) and diabetic kidney disease (DKD); 2. Baseline body mass index (BMI) 28.0 - 40.0 kg/m^2 with abdominal obesity (waist circumference >= 90 cm for men and = 85 cm for women); 3. Age 18 - 75 years old; 4. Disease duration 0 - 5 years; 5. Baseline glycated hemoglobin (HbA1c) >= 6.5%; 6. Non-naïve patients have been treated with stable doses of hypoglycemic drugs for at least 8 weeks.
Exclusion criteria
Exclusion criteria: 1. Exclusion of chronic kidney disease caused by other reasons; 2. Pregnant, planning to be pregnant or lactating women; 3. Acute complications of diabetes such as DKA or HHS occurred within the last 6 months; 4. Use of GLP-1 receptor agonists or weight loss drugs within the last 3 months; 5. Acute or chronic liver disease, or two consecutive tests of transaminase (ALT or AST) within the upper limit of the normal range 3 times or more within 4 weeks before screening, severe renal insufficiency or end-stage renal disease; 6. Significant cardiovascular and cerebrovascular events within the last 3 months before screening: congestive heart failure reaching NYHA grade III or IV, myocardial infarction, TIA, cerebral infarction, etc.; 7. History of recurrent urinary tract infections; 8. History of ketoacidosis within the last half year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin;Fasting blood glucose;Microalbuminuria;Urine microalbuminuria/creatinine ratio;Serum liquid;Grip strength;Muscle mass;6-meter walking speed;Abdominal fat;Myostatin; | — |
Countries
China
Contacts
Qingpu Branch of Zhongshan Hospital affiliated to Fudan University