Diabetes mellitus type 2
Conditions
Interventions
Experimental group:Feeding Xinsulin
Control group:Feeding Ruidai
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18-75 years old (inclusive) and 24kg/?=90cm for males, >=85cm for females; (2) Hypertension: blood pressure >=130/85mmHg and/or those who have been confirmed to be treated for hypertension; (3) Fasting triglycerides (TG) >=1.7mmol/L; (4) Fasting high-density lipoprotein cholesterol (HDL-C) < 1.04mmol/L; 5. Able to receive enteral nutrition and have not used similar or identical products for meal replacement within 1 month; 6. The patient himself has fully understood the study procedures of this trial and is willing to sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Those who suffer from inborn metabolic disorders or are allergic to any of the ingredients in the product; 2. Patients who are not suitable for enteral nutrition, such as stress ulcers, severe abdominal distention, diarrhea and other digestive and absorption dysfunctions; 3. Fasting C-peptide < 100 pmol/L (0.3 ng/mL); 4. Life expectancy < = 12 months; 5. Patients with severe cardiologic insufficiency (New York Heart Association [NYHA] Class III and above); Impaired hepatic or renal function (glomerular filtration rate < 60 mL/min/1.73 m2, or aminotransferase or transpeptidase levels greater than 3 times the upper limit of normal); Patients with active hyperthyroidism, refractory hypothyroidism and other diseases; or patients with neuropathy or abnormal brain function. 6. Have recently (within 1 month) adjusted the treatment plan of diabetes or have had acute complications of diabetes, such as diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome; 7. Women who are pregnant or planning to become pregnant or breastfeeding; 8. Participate in other interventional clinical trials within 4 weeks before screening, including trials involving hypoglycemic drugs, nutritional preparations, medical devices, etc.; 9. Those who are currently using or have used any of the following drugs within 3 months: chlorpromazine, olanzapine, clozapine, tacrolimus, cyclosporine A, levodopa, etc.; 10. Have a history of chronic pancreatitis or have had acute pancreatitis within 6 months; 11. Patients with active malignant tumors; 12. Other conditions that, in the opinion of the investigator, do not meet the conditions of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HOMA-IR; | — |
Secondary
| Measure | Time frame |
|---|---|
| GA,Body weight,Waist,Hip;Hemoglobin,Albumin,Biceps circumferenc;Vital signs, physical examination, laboratory tests (complete blood count, biochemical profile, urinalysis, liver and kidney function tests, lipid profile, electrolyte levels), gastrointestinal reactions, AE and SAE.; | — |
Countries
China
Contacts
Public ContactChen Wei
Peking Union Medical College Hospital
Outcome results
None listed