This study aims to evaluate the efficacy and safety of Hebenrun (a functional food based on natural grain bran) combined with metformin in patients with type 2 diabetes mellitus (T2DM). The study hypothesis is that Hebenrun combined with metformin will achieve a higher complete discontinuation rate of oral hypoglycemic drugs compared to metformin alone. A total of 110 T2DM patients will be randomly assigned (1:1) to the study group (metformin + Hebenrun) or the control group (metformin alone) and followed for 48 weeks. The primary outcome is the complete discontinuation rate of oral hypoglycemic drugs at the end of follow-up.
Meets the Western medicine diagnostic criteria for type 2 diabetes (T2DM), referring to the Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 Edition). If typical diabetes symptoms are present (such as polydipsia, polyuria, polyphagia, unexplained weight loss), meeting any one of the following can confirm the diagnosis: fasting blood glucose (FBG) ≥7.0 mmol/L; random blood glucose ≥11.1 mmol/L; oral glucose tolerance test (OGTT) 2-hour blood glucose ≥11.1 mmol/L; glycated hemoglobin (HbA1c) ≥6.5%. If typical diabetes symptoms are lacking, two of the above blood glucose indicators at the same time point or at two different time points (excluding random blood glucose) need to reach or exceed the diagnostic cut-off point to diagnose diabetes.
Age 18-65 years, glycated hemoglobin (HbA1c): 6.5%-8.5%.
Good patient compliance, cooperation with treatment and follow-up.
The research has been approved by the hospital ethics committee, and all patients voluntarily participate and sign informed consent.
Type 1 diabetes, gestational diabetes, and special types of diabetes.
History of acute diabetic complications (ketoacidosis, hyperosmolar coma, lactic acidosis).
Major organ diseases (severe heart, liver, kidney dysfunction), malignant tumors, or severe mental disorders.
Contraindications or allergy history to any component of Hebenrun.
Parallel
Metformin
DrugMetformin tablet, 0.5 g, twice daily, taken before meals; dose may be adjusted ±500 mg/d based on glycemic control; treatment duration: 48 weeks.
Hebenrun
Dietary supplementHebenrun, a functional food based on natural grain bran, taken as one sachet twice daily (morning and evening) before meals, for 48 weeks.
Complete discontinuation rate of oral hypoglycemic drugs
Complete discontinuation is defined as: (1) Complete discontinuation of all hypoglycemic drugs (insulin, metformin, GLP-1, SGLT-2, sulfonylureas, etc. all stopped; not including simple antihypertensive or lipid-regulating drugs); (2) Discontinuation sustained for ≥3 months, with glycated hemoglobin (HbA1c) ≤6.5% and fasting blood glucose (FBG) ≤7.0 mmol/L. The complete discontinuation rate = (number of patients meeting the complete discontinuation criteria at the end of follow-up) / (total enrolled diabetic patients in the group) × 100%.
Partial discontinuation rate of metformin at follow-up endpoint
Partial discontinuation is defined as: (1) Compared with baseline metformin 1000 mg/day, the metformin dose at follow-up endpoint is less than 1000 mg/day, without addition of other hypoglycemic drugs (insulin, GLP-1, SGLT-2, sulfonylureas, etc., not including simple antihypertensive or lipid-regulating drugs); (2) Dose reduction sustained for ≥3 months, with glycated hemoglobin (HbA1c) ≤6.5% and fasting blood glucose (FBG) ≤7.0 mmol/L.
Mean reduction in daily metformin dose (mg/d) from baseline to endpoint
Mean reduction in daily metformin dose at the end of follow-up compared to baseline dose.
Changes in HbA1c from baseline at each visit
Difference in glycated hemoglobin (HbA1c) at each visit time point relative to baseline.
Changes in fasting plasma glucose (FPG) from baseline at each visit
Difference in fasting plasma glucose (FPG) at each visit time point relative to baseline.
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Jiangxi University of Traditional Chinese Medicine
Lead sponsor
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Collaborator
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