Diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above, with no restrictions on gender. 2. Diagnosed with type 2 diabetes mellitus (T2DM) or impaired glucose tolerance (IGT) by a medical institution, with a fasting blood glucose (FBG) level ranging from 6 to 8 mmol/L or a 2-hour postprandial blood glucose (2h PPG) level ranging from 8 to 10 mmol/L. 3. Currently on a stable hypoglycemic regimen for no less than 60 consecutive days, with no anticipated need for regimen adjustment during the clinical trial period. 4. Able and willing to cooperate with and complete the dietary survey prior to enrollment. 5. Voluntarily participates in the nutritional intervention and signs the written informed consent form for the study.
Exclusion criteria
Exclusion criteria: 1. Patients who are unable to take oral nutrition, or whose oral intake fails to meet their own nutritional requirements, such as those with chewing or swallowing disorders, reduced gastrointestinal motility, etc. 2. Patients with diseases that impair food digestion and absorption, including severe gastrointestinal inflammation, active peptic ulcers, post-gastrointestinal resection status, short bowel syndrome, etc. 3. Patients with comorbid acute or chronic infectious diseases (e.g., tuberculosis, HIV infection, viral hepatitis); those with abnormal liver function (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels exceeding 3 times the upper limit of normal [ULN]); those with renal diseases (serum creatinine levels exceeding the upper limit of normal); and patients with malignant tumors. 4. Patients with hyperuricemia or gout. 5. Patients with psychiatric disorders. 6. Patients who are pregnant or lactating. 7. Patients with communication difficulties that prevent them from completing questionnaires, such as those with speech, hearing or visual impairments, etc. 8. Patients with known allergies to any component of the study intervention diet, or patients with congenital metabolic disorders. 9. Any other circumstances that the investigators deem inappropriate for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated albumin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin;Glucose;16S rRNA of gut microbiota;Body Composition Analysis; | — |
Countries
China
Contacts
The Second Affiliated Hospital of Zhejiang University School of Medicine