Diabetic kidney disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Type 2 diabetes mellitus and a clinical diagnosis of DKD defined as either urine albumin - to - creatinine ratio (UACR) =30 mg/g, or estimated glomerular filtration rate (eGFR) at 30 - 60 ml/min/1.73 m2 for > 3 months; 2) 18 - 75 years old; 3) Glycated hemoglobin (HbA1c) level at 7.0 - 10.0 %; 4) Stable treatment with = 3 oral hypoglycemic agents for > 3 months; 5) Dyslipidemia was diagnosed based on the Chinese lipid management guidelines or if the patients were taking the lipid regulating drugs; 6) Receiving maximum tolerated labelled renin - angiotensin system inhibitor therapy for > 3 months; 7) Voluntarily participate in and cooperate with research, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) A screening calcitonin value of at least 50 ng/L; 2) Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2; 3) Abnormal liver function with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than three times the normal upper limit; 4) Known significant nondiabetic kidney disease, a recent history of dialysis for acute kidney failure, a kidney transplant; 5) Chronic pancreatitis, idiopathic acute pancreatitis; 6) Uncontrolled hypertension; 7) Severe diabetic complications such as diabetic ketoacidosis, hyperosmotic hyperglycaemia syndrome and lactic acidosis, and severe cardiovascular & cerebrovascular diseases (e.g. stroke, transient ischemic cerebral attack, acute coronary syndrome, or heart failure) in the 90 days before the screening visit; 8) Use of glucagon-like peptide-1 receptor agonist within 3 months prior to screening; 9) Pregnancy/lactation; 10) Any contraindication for MRI examination (e.g. pacemaker, metal prosthesis, severe claustrophobia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum creatinine;eGFR;UACR;Renal tubular injury markers;Abdominal fat quantification;Renal blood flow;Water diffusion;Renal oxygenation;Serum and urine a- Klotho ß- Klotho;Oxidative stress indicators (4-HNE, MDA, GSH); | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c;Weight;Waist circumference;Hip circumference;Body mass index;FBG;Blood lipid; | — |
Countries
China
Contacts
Chu Hsien-I Memorial Hospital of Tianjin Medical University