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Explore the efficacy of dapagliflozin combined with probiotics on clinical remission and the intestinal flora in overweight and obese patients with type2 diabetes mellitus

Explore the efficacy of dapagliflozin combined with probiotics on clinical remission and the intestinal flora in overweight and obese patients with type2 diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106078
Enrollment
Unknown
Registered
2025-07-17
Start date
2023-01-10
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Overweight and obesity type 2 diabetes

Interventions

Control group:On the basis of the original treatment, dapagliflozin 10mg/day was given orally in the morning for 12 weeks and 24 weeks.
Experimental group:On the basis of the original treatment, dapagliflozin (10 mg/day, oral in the morning) combined with Bifidobacterium triple viable tablets (3 tablets/time, 2 times/day) was given fo

Sponsors

Jinan University Affiliated Shunde Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-60 years old; 2. Meet the diagnostic criteria for diabetes mellitus in WHO1999; 3. The course of the disease >=1 year; 4. Body mass index (BMI) >=24.0kg/m^2; 5. Prior treatment with metformin and premixed insulin > = half a year; 6. Glycosylated hemoglobin (HbA1c) >=7.0%; 7.eGFR>=60ml/min/1.73m^2; 8. Patients who cooperate with this study and agree to maintain the same diet and exercise habits throughout the trial and have complete data; 9. Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. T1DM, gestational diabetes, adult occult autoimmune diabetes and other special types of DM; 2. Gastrointestinal diseases (such as irritable bowel syndrome, inflammatory bowel disease, peptic ulcer, history of gastrointestinal bleeding, etc.) or history of gastrointestinal surgery (such as: gastrectomy, gastrointestinal anastomosis, bowel resection, etc.); 3. Acute complications of DM (hyperosmolar hyperglycemic coma, diabetic ketoacidosis and acute infection, etc.); 4. Various chronic complications of diabetes mellitus (diabetic nephropathy, diabetic retinopathy, etc.); 5. Combined with primary or secondary cardiopulmonary insufficiency, liver and kidney insufficiency; 6. Patients with infectious diseases such as active tuberculosis; 7. Patients with acute pancreatitis/have suffered from acute pancreatitis; 8. Pregnant and lactating women; 9. Addicts to alcohol and drug dependence; 10. Use of antibiotics within the past 12 weeks; 11. Have taken yogurt, fermented foods, dietary supplements (fish oil, probiotics, prebiotics, multimicrobials, minerals, nutritional foods or herbal preparations) and other foods or preparations that affect the intestinal flora in the past 4 weeks.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose;Blood sugar 2 hours after meal;Glycated hemoglobin;Triglyceride;Total Cholesterol;Low-density lipoprotein cholesterol;High-density lipoprotein cholesterol;High-sensitivity C-reactive protein ;Fasting insulin;Fecal bacteria;

Countries

China

Contacts

Public ContactKunyi LI

Jinan University Affiliated Shunde Hospital

201279760@qq.com+86 757 2838 5759

Outcome results

None listed

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