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Study for dapagliflozin on glomerular hyperfiltration and visceral fat redistribution in patients with newly diagnosed type 2 diabetes mellitus

A randomized, controlled trial for evaluating the glomerular hyperfiltration and visceral fat redistribution in new-onset type 2 diabetic patients treated with dapagliflozin for 24 weeks

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023470
Enrollment
Unknown
Registered
2019-05-30
Start date
2019-06-27
Completion date
Unknown
Last updated
2019-06-03

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

Conditions

Type 2 Diabetes Mellitus

Interventions

Sponsors

Tianjin Metabolic Diseases Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. New diagnosis of type 2 diabetes (new diagnosis of type 2 diabetes: a history of no diabetes, no hypoglycemic treatment, and reached the diagnostic criteria for type 2 diabetes in the past 1 year). 2. Male or female, older than 18 years old. 3. HbA1c was between 7.5% and 10.5% in the early screening, and HbA1c was between 7.0% and 10.5% before the start of the visit. 4. Fasting blood glucose is less than 13.3mmol/L. 5. BMI between 18.5kg/m2 and 45.0kg/m2. 6. Fasting C-peptide level is greater than 0.33nmol / L. 7. Voluntary participation and cooperation in research and signing informed consent.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or planning to become pregnant, breastfeeding or have a fertility willingness in the near future; 2. Patients with pacemakers, neurostimulators, artificial metal heart valves, etc.; 3. Patients with aneurysm clip; 4. There are intraocular metal foreign bodies, inner ear implants, metal prostheses, metal joints, and ferromagnetic foreign bodies in the body; 5. Severe hyperthermia patients; 6. Patients with epilepsy or claustrophobia or who cannot cooperate with nuclear magnetic examination; 7. Patients with severe diabetic complications such as diabetic ketoacidosis, hyperosmolar hyperglycemia syndrome, lactic acidosis, etc.; 8. Patients with unstable glycemic control who must use insulin to control blood sugar; 9.Blood lipids are significantly elevated, fasting triglycerides are greater than 9.3mmol / L; 10. Abnormal liver function, ALT or AST is more than 3 times the upper limit of normal (based on laboratory results 1 month before the experiment); 11. Acute myocardial infarction, cerebrovascular accident and severe infection occurred within 6 months prior to enrollment; 12. Glomerular filtration rate <60 ml / min / 1.73m2 (based on laboratory test results 1 month before the experiment); 13. Previous diagnosis of heart failure, myocardial infarction or percutaneous coronary intervention; 14. Previously used or currently treated with SGLT-2i; 15. Allergic to SGLT-2i, lactose or acarbose; 16. Have poorly controlled hypertension; blood pressure systolic blood pressure greater than 180mmHg, systolic blood pressure greater than 110 mmHg; 17. Previous gastrointestinal disease or surgical history, including intestinal obstruction, intestinal ulcer, weight loss surgery or banding surgery, gastrointestinal anastomosis, intestinal resection; 18. History of previous immunocompromised or malignant tumors; 19. Use of glucocorticoids and other drugs that affect blood sugar; 20. Currently using loop diuretics; 21. Patients with a history of mental illness, who have not followed the research plan and are conducting research tasks.

Design outcomes

Primary

MeasureTime frame
Renal RBF (blood flow per 100 grams of tissue per minute);Measuring the oxygenation status of kidney tissue;Diffusion movement in renal tissue;Fat quantitative measurement;Glycated hemoglobin;

Secondary

MeasureTime frame
Change in fasting blood glucose;Postprandial blood glucose change;BMI change;Change in systolic blood pressure;

Countries

China

Contacts

Public ContactPei Yu

Tianjin Metabolic Diseases Hospital

Yupei@tijmu.edu.cn+86 13821008270

Outcome results

None listed

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