Diabetes mellitus type 2
Conditions
Interventions
Experimental group:Orally consume a special medical nutritional food for diabetes (An Yiping) as a partial nutritional supplement to provide 8~10 kcal/kg·d of energy daily.
Control group:Take orally Re-Dai as a partial nutritional supplement to provide 8~10 kcal/kg·d of energy daily
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, regardless of gender or ethnicity. 2. 24.0 kg/m^2== 90 cm in men, >= 85 cm in women. (2) Elevated blood pressure: blood pressure >= 130/85 mmHg, or a confirmed diagnosis of hypertension currently under treatment. (3) Fasting triglycerides (TG) >= 1.7 mmol/L, or a confirmed diagnosis of elevated TG currently receiving pharmacological treatment. (4) Fasting high-density lipoprotein cholesterol (HDL-C) < 1.04 mmol/L, or a confirmed diagnosis of low HDL-C currently receiving pharmacological treatment. 6. Tolerance to enteral nutrition. 7. Full understanding of the study procedures and voluntary provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Life expectancy = 3 × upper limit of normal, or total bilirubin > 2 × ULN, or glomerular filtration rate < 30 mL/min/1.73m^2]; 8. Patients with active hyperthyroidism, refractory hypothyroidism, or those with severe psychiatric disorders or cognitive impairments; 9. History of chronic pancreatitis or occurrence of acute pancreatitis within the past 6 months; 10. Patients with active malignant tumors or undergoing antitumor therapy; 11. Occurrence of acute complications such as diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, severe hypoglycemia, or adjustments to diabetes medication due to glycemic control issues within 1 month prior to screening; 12. Use of other nutritional preparations that may affect trial outcomes, such as enteral or parenteral nutrition formulations, within 2 weeks prior to screening; 13. Use of medications that may interfere with insulin sensitivity within 3 months prior to screening or planned use during the trial, including chlorpromazine, olanzapine, clozapine, tacrolimus, cyclosporine A, levodopa, etc.; 14. Participation in other interventional clinical trials and receipt of treatment within 1 month prior to screening; 15. Other situations deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin Resistance Index ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose-related indicators: Fasting blood glucose, Glycated albumin;Safety assessments: vital signs, physical examination, electrocardiogram, laboratory tests (complete blood count, urinalysis, blood biochemistry), gastrointestinal symptoms, adverse events, adverse reactions, serious adverse events, serious adverse reactions;Metabolic indicators: Body composition, Calf circumference, Waist circumference, Waist-to-hip ratio, Body weight;Nutritional adequacy indicators: Serum albumin; | — |
Countries
China
Contacts
Public ContactChen Wei
Peking Union Medical College Hospital
Outcome results
None listed