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Study of the effect and mechanism of Jinlida granules combined with insulin on blood glucose and insulin sensitivity in obese type 2 diabetes patients based on intestinal flora

Study of the effect and mechanism of Jinlida granules combined with insulin on blood glucose and insulin sensitivity in obese type 2 diabetes patients based on intestinal flora

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057005
Enrollment
Unknown
Registered
2022-02-25
Start date
2022-02-23
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

Type 2 diabetes

Interventions

Experimental group:Jinlida+ insulin intensive therapy + lifestyle intervention
Control group:Insulin intensive therapy + lifestyle intervention

Sponsors

He'nan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the 1999 WHO standards for diagnosis and treatment of diabetes; 2. Insulin resistance or relative lack; 3. Aged 18-70 years; 4. Course of disease = 25 kg/m^2; 6. HbA1c > 9.0%; 7. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Antibiotics have been used within the past 3 months for 3 days or more; 2. Persistent vomiting or suspected gastrointestinal obstruction; 3. Gastrectomy, fundus folding, colostomy and other digestive system surgery; 4. Patients with acute or chronic inflammatory diseases or infectious diseases, or who are receiving antibiotics, probiotics, probiotics or any other medications that may affect the gut microbiome during the 3 months prior to inclusion; 5. Patients with moderate or severe renal function injury (serum creatinine > 2 mg/dL or 177 mmol/L) or abnormal liver function (ALT > 2 times the upper limit of normal value); moderate to severe chronic obstructive pulmonary disease; patients with severe hypertension and cerebrovascular accidents; 6. There are serious cardiovascular, cerebrovascular, liver, kidney and hematopoietic system diseases; 7. Suffering from serious organic diseases, such as cancer, coronary heart disease, myocardial infarction and stroke; 8. Suffering from infectious diseases such as tuberculosis and AIDS; 9. Patients with severe diabetes complications, such as diabetic ketosis, ketoacidosis, lactic acidosis, diabetic hyperosmolar state, diabetic foot, severe retinopathy, etc.; 10. Alcoholism (drinking more than 5 times a week, with an average of 2 taels of white wine or half catty yellow wine or 5 bottles of beer every time ); 11. Abnormal thyroid function such as cholecystitis, gastrointestinal ulcer, urinary tract infection, acute pyelonephritis, cystitis and hyperthyroidism; 12. Pregnant and lactating patients; 13. Anemia: hemoglobin < 10 g/dL; 14. Physically disabled, or otherwise unable to take care of themselves, recall clearly, answer questions, or have obvious motor disorders; 15. There is no guarantee of sufficient time to participate in the project.

Design outcomes

Primary

MeasureTime frame
Change in HBA1c from baseline;

Secondary

MeasureTime frame
Change in fasting blood glucose from baseline;Change in 2h postprandial blood glucose compared to baseline;Change in glucose tolerance test (OGTT) from baseline;Change in body weight from baseline;Change in body mass index (BMI) from baseline;Changes of four blood lipids compared with baseline;Changes of hepatorenal function and metabolism-related indicators compared with baseline;Change in C-peptide release test from baseline;Change in serum creatinine compared to baseline;Change in serum uric acid compared to baseline;Change in waist circumference from baseline;

Countries

China

Contacts

Public ContactYuan Huijuan

He'nan Provincial People's Hospital

lmls3712@163.com+86 13513891997

Outcome results

None listed

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