Type 2 diabetes and chronic kidney
Conditions
Interventions
Group A:The patients in this group followed a fixed low-sodium diet daily while taking henagliflozin orally
Group B:The patients in this group followed a fixed medium-sodium diet daily while taking henagliflozin orally
Group C:The patients in this group followed a fixed high-sodium diet daily while taking henagliflozin orally
Sponsors
The Fourth Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for type 2 diabetes as defined by the World Health Organization (WHO) in 1999; 2.Age between 18 and=60 mL/min/1.73 m^2 and urine albumin-to-creatinine ratio (UACR) >=30 mg/g in patients with chronic kidney disease stages G1 and G2. 4.Ability to sign a written informed consent; 5.Hemoglobin A1c (HbA1c) level between >=6.5% and <10%; 6.Stable dose of metformin, sulfonylureas (SU), or a combination of metformin and SU for at least 3 months before enrollment, with optional insulin use but not mandatory. Continuous use of angiotensin-converting enzyme inhibitors (ARB) or angiotensin-converting enzyme inhibitors (ACEi) for at least 6 weeks.
Exclusion criteria
Exclusion criteria: 1. Allergy to medications; 2. History of diabetic ketoacidosis, fragile diabetes, and/or frequent hypoglycemia within the past 6 months or severe hypoglycemic episodes requiring urgent intervention; 3. History of urinary retention symptoms, bladder dysfunction, or urinary incontinence; 4. Acute, chronic, or recurrent infections of the urinary or genital tract; 5. History of relevant orthostatic reactions; 6. Repeated measurements of systolic blood pressure (SBP) =110 mmHg; 7. Pregnant or breastfeeding; 8. Abnormal thyroid function or autonomic thyroid adenoma; 9. Abnormal adrenal function; 10. Abnormal function of the pituitary gland gland; 11. History of unstable or rapidly progressing renal disease, albumin-to-creatinine ratio >1000 mg/g; 12. Moderate to severe hepatic insufficiency (Child-Pugh class B and C); 13. Use of pacemaker or other implantable electronic device; 14. Cardiovascular and cerebrovascular events within 3 months prior to screening; 15. History of previous amputation, peripheral vascular disease, and diabetic foot ulcers; 16. No other hypoglycemic drugs (except metformin, SU, and insulin), NSAIDs are allowed during the study; 17. Treatment with diuretics, mineralocorticoid receptor antagonists during the study or within 2 weeks before the study; Taking other drugs that may affect water and salt metabolism, such as anticonvulsants, antipsychotics, chemotherapy drugs, glucocorticoids, immunosuppression or other immunotherapeutic drugs, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fractional proximal tubular sodium reabsorption rate of sodium (FPRNa); | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood indicators;Urine indicators;Renal imaging examination; | — |
Countries
China
Contacts
Public ContactJiang Hua
The Fourth Medical Center of Chinese PLA General Hospital
Outcome results
None listed