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A randomized, controlled trial to evaluate the improvement of oxidative stress levels and renal function in patients with diabetic kidney disease treated with semaglutide for 28 weeks

Study on the effect and mechanism of semaglutide in alleviating diabetic renal damage

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080751
Enrollment
Unknown
Registered
2024-02-06
Start date
2023-03-27
Completion date
Unknown
Last updated
2024-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic kidney disease

Interventions

A group:Insulin detemir
B group:Semaglutide

Sponsors

Chu Hsien-I Memorial Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
32 Years to 74 Years

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

MeasureTime 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

MeasureTime frame
HbA1c;Weight;Waist circumference;Hip circumference;Body mass index;FBG;Blood lipid;

Countries

China

Contacts

Public ContactPei Yu; Tian Shasha

Chu Hsien-I Memorial Hospital of Tianjin Medical University

yupei@tmu.edu.cn+86 138 2100 8270

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026