Type 2 diabetes
Conditions
Interventions
Test group:Tang'ansu
Control group:Ruidai (intestinal nutrition emulsion TPF-D)
Sponsors
General Hospital of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1) 18-90 years old, including boundary values; (2) According to the diagnostic criteria of China's Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition), the diagnosis of type 2 diabetes is confirmed, and it is expected that there is no need to adjust the treatment plan in the next month during screening; (3) After 1 month of dietary intervention, lifestyle intervention and stable oral hypoglycemic drugs, glycated hemoglobin =3; (5) Sign the informed consent voluntarily on the basis of a full understanding of the test.
Exclusion criteria
Exclusion criteria: (1) Patients who are not suitable for enteral nutrition, such as active gastrointestinal bleeding, intestinal ischemia, paralytic/mechanical intestinal obstruction, reduced gastrointestinal tension, stress ulcers, and severe abdominal distension, diarrhea and other digestive and absorption dysfunctions; (2) The local skin is seriously damaged, affecting the use of the CGM system; (3) The patient participated in other interventional clinical trials, including those related to nutritional support, within 4 weeks before joining the group; (4) New York Society of Cardiology (NYHA) Cardiac Function Grade III and above; (5) There are major cardiovascular events 2 weeks before screening; (6) Pregnancy or lactation; (7) A known history of allergy to any component of the research product; (8) There are acute complications of diabetes within 3 months before screening, such as diabetic ketoacidosis and hyperosmotic hyperglycemia syndrome; (9) The dosage of hyperthyroidism and hypothyroidism is stable for less than 3 months; (10) Combined with tumor malignant fluid; (11) Patients with hepatorenal insufficiency [Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >=3×normal upper limit (ULN); total bilirubin (TBIL) >=2×ULN; creatinine (Cr) >=1.5×ULN]; (12) Subjects with severe hyperglyceridesemia (triglyceride >=5.6 mmol/L), hypoproteinemia (albumin <20 g/L), severe immunosuppression (neutrophil <1500/mm3 or lymphocytes <500/mm3), infection, high fever and other stress disorders; (13) Other nutritional preparations that may affect the effect of the test are being used; (14) Subjects who have used systemic glucocorticoid therapy within 2 weeks before screening or are planned to use it during the study; (15) The subjects had one of the following conditions: hemodynamic instability, multiple injuries that are life-threatening, and severe acidosis, shock and sepsis; (16) Those who use insulin or glucagon-like peptide-1 receptor agonist (GLP-1 RA); (17) Patients with diabetic nephropathy; (18)Other researchers believe that cases that do not meet the conditions for this study, such as inflammatory bowel disease (Cron's disease or ulcerative colitis), acute pancreatitis, and unstable vital signs, if they exist, should record the reasons that do not meet the study conditions.
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 Army
Outcome results
None listed