Type 2 diabetic nephropathy
Conditions
Interventions
Flexible Ketogenic Diet Group:routine hypoglycemic treatment + flexible ketogenic diet
Henagliflozin Positive Control Treatment Group:routine hypoglycemic treatment + Henagliflozin 10mg qd po
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Ages between 18 and 60 years inclusive; (2) Newly diagnosed type 2 diabetes mellitus (T2DM) or patients who have been on a stable dose of hypoglycemic medication for at least 4 weeks with poor blood glucose control (7.0% = HbA1c = 11.0%) (WHO criteria, 1999); (3) Meet the diagnostic criteria for diabetic kidney disease (DKD), which refers to chronic kidney disease caused by diabetes, mainly characterized by persistent increased urinary albumin excretion rate and/or progressive decline in glomerular filtration rate (GFR) below 60 ml/min/1.73m^2 or a urinary albumin/creatinine ratio (ACR) above 30 mg/g for more than 3 months. (4) Overweight or obese: BMI = 24 kg/m^2 or waist circumference > 85 cm or body fat rate = 28%. (5) Willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Type 1 diabetes, immunological diabetes, carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine transferase II deficiency, beta-oxidation enzyme deficiency, medium-chain acyl dehydrogenase deficiency, long-chain acyl dehydrogenase deficiency, short-chain acyl dehydrogenase deficiency, medium-chain 3-hydroxyacyl CoA dehydrogenase deficiency, long-chain 3-hydroxyacyl CoA dehydrogenase deficiency, pyruvate carboxylase deficiency, porphyria, etc. (2) Type 2 diabetes with ß-cell failure, LADA, eating disorders, severe impairment of vital organs (heart, liver, lung, kidney, etc.), recent (within 12 months) myocardial infarction and cerebral infarction, decreased cardiac ejection fraction, unstable angina, arrhythmia, etc., ALT, AST levels more than three times the upper limit of normal, GFR = 45ml/min, SBP = 180mmHg and/or DBP = 110mmHg, fat digestion disorders, urinary system stones, pancreatitis history, active cholecyst disease, frequent gout, fat digestion disorders, renal failure history, pregnancy and lactation, active infection or very poor physical condition, inability to cooperate with the study. Endocrine system diseases, such as hyperthyroidism, hypothyroidism, Cushing's syndrome, etc., affecting fatty liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| random urinary albumin/creatinine ratio;24h urinary protein quantification;serum creatinine level;serum urea nitrogen level;estimated glomerular filtration rate;indicatorstotal effective rate;adverse reaction rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose;Glycated Hemoglobin, HbA1c;Fasting Insulin/C-Peptide;Triglycerides;Total Cholesterol;Low-Density Lipoprotein Cholesterol, LDL-C;High-Density Lipoprotein Cholesterol, HDL-C;Alanine Aminotransferase (ALT) Levels;Homeostasis Model Assessment of Insulin Resistance, HOMA-IR;Body Fat Percentage;Visceral Fat;Waist Circumference; | — |
Countries
China
Contacts
Public ContactHuang Wei
Affiliated Hospital of Southwest Medical University
Outcome results
None listed