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Evaluation of the early renal protective effects of Canagliflozin in patients with newly diagnosed type 2 diabetes mellitus using Blood Oxygen Level-Dependent and Arterial Spin Labeling MRI

A randomized, controlled trial for evaluating oxygenation and blood perfusion level of kidney in new-onset type 2 diabetic patients treated with Canagliflozin for 24 weeks

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037951
Enrollment
Unknown
Registered
2020-09-06
Start date
2019-09-01
Completion date
Unknown
Last updated
2020-11-16

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

Conditions

Newly diagnosed type 2 diabetes

Interventions

Sponsors

Tianjin Medical University Chu Hisen-I Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed type 2 diabetes (newly diagnosed type 2 diabetes: no previous history of diabetes, without hypoglycemic treatment, reached the diagnostic criteria of type 2 diabetes in the past year); 2. Male or female, older than 18 years old; 3. The HbA1c was between 7.5% and 10.5% during the pre-screening, and the HbA1c was between 7.0% and 10.5% before the visit; 4. Fasting blood glucose is less than 13.3 mmol/L; 5. BMI is between 18.5kg/m2 and 45.0kg/m2; 6. Fasting C-peptide level > 0.33nmol/L; 7. Voluntarily participate in and cooperate with the research and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or planning to be pregnant, lactating or willing to have children in the near future; 2. Patients with severe diabetic complications such as diabetic ketoacidosis, hyperosmotic hyperglycemia syndrome, lactic acidosis, etc; 3. Patients whose blood sugar control is unstable and must use insulin to control their blood sugar; 4. Blood lipids increased significantly, fasting triglyceride was more than 9.3 mmol/L; 5. Abnormal liver function, 3 times higher than the normal upper limit of ALT or AST (based on the results of laboratory examination one month before the experiment); 6. Acute myocardial infarction, cerebrovascular accident and severe infection occurred within 6 months before entering the group; 7. Urinary ACR > 30mg / g; glomerular filtration rate < 90 ml / min / 1.73m2; 8.Previous diagnosis of heart failure, myocardial infarction or percutaneous coronary intervention; 9. Previous or current use of SGLT-2i; allergic to SGLT-2i and glimepiride; 10. Suffering from poorly controlled hypertension; systolic blood pressure greater than 180mmHg, systolic blood pressure greater than 110 mmHg; 11. Previous history of gastrointestinal diseases or operations, including intestinal obstruction, intestinal ulcer, weight loss surgery or banding surgery, gastroenterostomy, enterectomy; 12. Previous history of low immune function or malignant tumor; 13. The use of glucocorticoids and other drugs that affect blood sugar; 14. Loop diuretics are currently being used; 15. Patients with pacemakers, nerve stimulators, artificial metal heart valves, etc; 16. With aneurysm clip; 17. There are intraocular metal foreign bodies, inner ear implants, metal prostheses, metal joints, ferromagnetic foreign bodies in the body; 18. Patients with severe high fever; 19. Patients with epilepsy or claustrophobia or who are unable to cooperate with nuclear magnetic resonance examination; 20. A person who has a history of mental illness and is unable to follow the research plan and carry out research tasks.

Design outcomes

Primary

MeasureTime frame
Measuring the oxygenation status of kidney tissue;Measuring the blood perfusion level of the kidney;

Secondary

MeasureTime frame
eGFR;UCAR;Renal tubular function index;HbA1c;FBG;P2BG;Islet function;Body weight;Blood pressure;

Countries

China

Contacts

Public ContactZhou Saijun

Tianjin Medical University Chu Hisen-I Memorial Hospital

zhousaijun0102@126.com+86 13920611479

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026