Clinical trial NCT06182891: Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy
Official title: Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetic Nephropathy
Keywords: dulaglutide
diabetic nephropathy
renoprotective effects
Lead sponsor: The Affiliated Hospital of Xuzhou Medical University
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with other types of kidney disease
* Urinary tract infection
* Type 1 diabetes

Primary outcomes:
measure: Evaluation of the urinary albumin-to-creatinine ratio
timeFrame: 3,6 and 12 months after dulaglutide injection treatment
measure: Evaluation of the biomarkers of the epithelial-mesenchymal transition process
timeFrame: 3,6 and 12 months after dulaglutide injection treatment
Secondary outcomes:
measure: Evaluation of the estimated glomerular filtration rate
timeFrame: 3,6 and 12 months after dulaglutide injection treatment
measure: Evaluation of the cystatin C
timeFrame: 3,6 and 12 months after dulaglutide injection treatment
measure: Evaluation of adverse event
timeFrame: 3,6 and 12 months after dulaglutide injection treatment
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Department of Endocrinology
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Renhao Wang, Ph.D
role: STUDY_DIRECTOR
References: