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Effect of Enshuangping on Glucose and Lipid Metabolism and Fat Distribution in Obese Patients with Type 2 Diabetes Mellitus

Effect of Enshuangping on Glucose and Lipid Metabolism and Fat Distribution in Obese Patients with Type 2 Diabetes Mellitus

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066159
Enrollment
Unknown
Registered
2022-11-25
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

obesity, diabetes

Interventions

2:empagliflozin
3:Enshuangping

Sponsors

Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for obesity (BMI >=28kg/m^2); or adult male waist >=90cm, adult female waist >=85cm, or waist-to-hip ratio > 1.0; 2. All the patients meet the diagnostic criteria for type 2 diabetes; 3. Aged 18-65; 4. Glycosylated hemoglobin 6-8%; 5. Did not receive any drug treatment affecting glucose and lipid metabolism or weight loss surgery.

Exclusion criteria

Exclusion criteria: 1. Have been diagnosed with secondary obesity, such as hypothyroidism, Cushing's syndrome, polycystic ovary syndrome, etc.; 2. Severe cardiovascular and cerebrovascular diseases, rheumatic and immune diseases; 3. Severe metabolic diseases, such as diabetic ketoacidosis, hypertonic hyperglycemia, etc.; 4. Patients with type 1 diabetes or other special types of diabetes; 5. Severe liver dysfunction (AST and ALT of liver function exceed the upper limit of normal by more than 2.5 times); 6. Kidney disease or moderate to severe renal insufficiency. eGFR<45 ml/min/1.73m^2); 7. Patients who have taken or are taking loop diuretic, thiazide and other diuretics within the past month; 8. Pregnant and lactating women; 9. Diagnosis of tumor (except stable thyroid papillary carcinoma) or tumor status of chemotherapy, radiotherapy, acute nephropathy, etc.; 10. Patients who have advanced malignant tumors; 11. A history of drug use known to affect glucose and lipid metabolism, such as glucocorticoids, antibiotics, anti-anxiety or antidepressant drugs; 12. Patients who have severe hyperlipidemia and acute attacks of gout; 13. Presence of urogenital system infection; 14. Severe bleeding tendency and inability to complete venous blood collection; 15. There are contraindications of MRI examination, such as patients with cardiac pacemakers, nerve stimulators, artificial metal heart valves, etc.; Patients during pregnancy; Claustrophobic; Epilepsy patients, etc.; 16. Patients who refuse to undergo MRI examination; 17. Patients who are participating in other intervention studies; 18. Other conditions that the researchers consider are not appropriate to study.

Design outcomes

Primary

MeasureTime frame
Blood glucose;visceral adipose tissue content;insulin;C-peptide;glycosylated hemoglobin;cholesterol;triglycerides;free fatty acids;

Secondary

MeasureTime frame
inflammatory cytokines(IL-2,IL-6,IL- 8,IL-10,TNF-a);

Countries

China

Contacts

Public ContactJing Ma

Department of Endocrinology and Metabolism, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China

majing@renji.com+86 158 0098 3436

Outcome results

None listed

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