Type 2 diabetes
Conditions
Interventions
Experimental group:Take special medical purpose full-nutrition formula food for diabetes
Control group:Take special medical purpose full-nutrition formula food for diabetes
Sponsors
The First Medical Center of the General Hospital of the Chinese People's Liberation Arm
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-90 years old (including boundary values), no gender restriction; 2. Patients with type 2 diabetes who meet the diagnostic criteria of the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition)"; 3. After 1 month of dietary intervention, lifestyle intervention, and stable oral hypoglycemic drugs, glycated hemoglobin =3 points; 5. Expected not to require adjustment of hypoglycemic regimen during the clinical trial period; 6. Able to tolerate enteral nutrition; 7. Understand the purpose and process of the trial, voluntarily participate, and can sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe liver or kidney dysfunction [Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) =2.5 times the upper limit of normal (ULN), creatinine =1.5 times ULN]; 2. Presence of cancer cachexia; 3. New York Heart Association (NYHA) functional class III or higher; 4. Major adverse cardiovascular events within 1 month prior to screening; 5. Severe diabetes-related complications (proliferative diabetic retinopathy, diabetic foot with skin ulceration); 6. Severe local skin damage affecting the use of continuous glucose monitoring systems; 7. Acute diabetic complications within 3 months prior to screening, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state; 8. Presence of severe hypertriglyceridemia (triglycerides =5.6 mmol/L), hypoproteinemia (albumin <20 g/L), infection, high fever, or other stress conditions; 9. Use of insulin or glucagon-like peptide-1 receptor agonists (GLP-1 RA); 10. Use or planned use of other drugs or nutritional supplements that may affect trial outcomes within 2 weeks before the screening period or during the trial; 11. Patients unsuitable for enteral nutrition, including: (1) Complete mechanical intestinal obstruction, gastrointestinal bleeding, severe abdominal infection; (2) Early stage of severe stress or shock; (3) Early short bowel syndrome; (4) High-output jejunal fistula; (5) Persistent severe vomiting, intractable diarrhea, severe small intestine or colon inflammation; (6) Gastrointestinal dysfunction or conditions requiring bowel rest; 12. Acute severe pancreatitis; 13. Known allergy, intolerance, or congenital metabolic disorder related to the trial sample or its metabolites; 14. Injection or oral administration of glucocorticoids within 1 month prior to screening or expected during the clinical trial; 15. Unsuitable for body composition analysis, such as having a pacemaker or metal implants; 16. Pregnant or breastfeeding women, or those planning pregnancy during the study; 17. Participation in another clinical trial within 1 month prior to screening; 18. Other conditions deemed by the investigator to make the patient unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effect of special medical use; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical safety;Nutritional adequacy;Clinical effect of special medical use; | — |
Countries
China
Contacts
Public ContactYinghua Liu
The First Medical Center of the General Hospital of the Chinese People's Liberation Arm
Outcome results
None listed