Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy
- Conditions
- Type 2 Diabetic Nephropathy
- Interventions
- Registration Number
- NCT06182891
- Brief Summary
The purpose of the real-world observational prospective study is to access the renoprotective effects of dulaglutide as well as to explore corresponding mechanisms in patients with Type 2 Diabetic Nephropathy.
- Detailed Description
Related studies have found that Glucagon-like peptide-1 (GLP-1) receptors are localized on a variety of tissues and cell types in addition to pancreatic β-cells, and GLP-1 and GLP-1 receptor agonists can exert diverse effect on multiple organs and tissues, with pleiotropic potential physiological, pathophysiological as well as pharmacological implications. Multiple clinical trials suggest that GLP-1 receptor agonists can exert renoprotective effects and persuasively inhibit the progression of kidney disease in type 2 diabetic patients. The beneficial effects of GLP-1 receptor agonists on Type 2 Diabetic Nephropathy, independent of their hypoglycemic ability, might are mediated by anti-oxidative stress, anti-inflammatory and natriuresis properties. However, it is not clear whether the above-mentioned properties are involved in the EMT process of renal tubular epithelial cells.
All participants meeting all eligibility criteria received routine medical consultations. During routine medical visits, patients were randomized into two groups (1.07:1) to receive a total duration of 12 months of hypoglycemic therapy - dulaglutide plus other hypoglycemic agents not including GLP-1 receptor agonists (intervention group), and other hypoglycemic agents not including GLP-1 receptor agonists (control group). A random number method was applied for grouping in this study. Dulaglutide and other hypoglycemic agents were administered according to the drug package insert. Of course, the investigators decided on other background treatments for hypertension, hyperlipidemia, or cardiovascular-related risk factors based on the latest guidelines throughout the trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- All adults aged 18 and above
- No minors involved in the study
- Diabetic Nephropathy defined as a urinary albumin-to-creatinine ratio ≥30 mg/g at least twice in three measurements within a period of 3-6 months
- Patients with other types of kidney disease
- Urinary tract infection
- Type 1 diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dulaglutide Dulaglutide Injection Dulaglutide was injected subcutaneously at standard dose and frequency for consecutive 12 months. other hypoglycemic agents not including GLP-1 receptor agonists Dulaglutide Injection Other hypoglycemic agents not including GLP-1 receptor agonists were used at standard dose and frequency for consecutive 12 months.
- Primary Outcome Measures
Name Time Method Evaluation of the biomarkers of the epithelial-mesenchymal transition process 3,6 and 12 months after dulaglutide injection treatment the changes in the biomarkers of the epithelial-mesenchymal transition process from the baseline at 3, 6 and 12 months. These biomarkers of the epithelial-mesenchymal transition process include E-cadherin and periostin.
Evaluation of the urinary albumin-to-creatinine ratio 3,6 and 12 months after dulaglutide injection treatment the changes in the urinary albumin-to-creatinine ratio
- Secondary Outcome Measures
Name Time Method Evaluation of the cystatin C 3,6 and 12 months after dulaglutide injection treatment the changes in the cystatin C
Evaluation of the estimated glomerular filtration rate 3,6 and 12 months after dulaglutide injection treatment the changes in the estimated glomerular filtration rate
Evaluation of adverse event 3,6 and 12 months after dulaglutide injection treatment Tolerability and safety outcomes included the incidence of hypoglycemia, gastrointestinal reaction and other adverse events, which were recorded in detail at follow-up (3,6 and 12 months after dulaglutide injection treatment).
Trial Locations
- Locations (1)
Department of Endocrinology
🇨🇳Xuzhou, Jiangsu, China