This study is a multi-center, randomized, crossover investigator-initiated trial conducted at Shanghai Sixth People's Hospital and other centers. Each participant will undergo two 12-week dietary intervention phases, separated by a 6-week washout, for a total study duration of 30 weeks. Participants will be randomly assigned in a 1:1 ratio to one of two intervention order: (1) optimized carbohydrate diet-washout-conventional diabetes diet, or (2) conventional diabetes diet-washout-optimized carbohydrate diet. The optimized carbohydrate diet is a modified diet with adjusted carbohydrate composition and proportions, while the conventional diabetes diet adheres to an energy-matched protocol in accordance with diabetes dietary guidelines. The study aims to explore the effects of the optimized carbohydrate diet on blood glucose control and glucose metabolism in patients with type 2 diabetes, and to systematically assess its impact on cognitive function and a range of physiological and psychological indicators (such as depression, anxiety, appetite, sleep, bowel habits and others).
Patients diagnosed with type 2 diabetes according to the ADA diagnostic criteria
HbA1c ≥ 7% and < 9%
Antidiabetic medication has been stable for at least 3 months before recruitment
Aged 35-70 years
Treatment with insulin
Treatment with GLP-1 receptor agonists or DPP-4 inhibitors
Occurrence of diabetic ketoacidosis, lactic acidosis, hyperosmolar coma, or recurrent severe hypoglycemia within the past year
Having one or more severe chronic diabetic complications, including advanced diabetic retinopathy, macroalbuminuria (urine albumin-to-creatinine ratio ≥300 mg/g), or impaired renal function (eGFR ≤60 ml/min/1.73 m²)
Crossover
optimized carbohydrate diet
Other interventionIn this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 15-20% of daily starch intake (around 40 g/day), slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 75-80%, with dietary fiber at 20-40g per 1000 kcal and free sugars contributing less than 5% of total energy.
conventional diabetes diet
Other interventionIn this dietary pattern, 50-60% of total energy is derived from carbohydrates, 15-20% from protein, and 25-30% from fat. Among the carbohydrates, resistant starch (RS) constitutes 5% of daily starch intake, slowly digestible starch (SDS) 5%, rapidly digestible starch (RDS) 90%, with dietary fiber at 14g per 1000 kcal and free sugars contributing less than 5% of total energy.
Change in the average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours
Average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours will be measured at -2, 0, 10, 16, 18, and 28 weeks using the continuous glucose monitoring system.
Change in other parameters of Continuous Glucose Monitoring
Other parameters of Continuous Glucose Monitoring, including Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), Mean Glucose, Glucose Variability, Glycemic Excursions, Area Under the Curve (AUC), and other relevant metrics, will be assessed at -2, 0, 10, 16, 18, and 28 weeks.
Change in HbA1c
HbA1c will be measured at baseline, 12, 18 and 30 weeks. HbA1c will be expressed in mmol/mol.
Change in insulin sensitivity
Insulin sensitivity will be assessed at baseline, 12, 18 and 30 weeks.
Change in other clinical biochemical indicators
Other clinical biochemical indicators will be measured at baseline, 4, 8, 12, 18, 22, 26 and 30 weeks.
Change in the iAUC of postprandial blood glucose over 3 hours after each meal
The iAUC of postprandial blood glucose over 3 hours after each meal in patients with type 2 diabetes will be measured at -2, 0, 10, 16, 18, and 28 weeks using the continuous glucose monitoring system.
Change in hepatic fat content
Hepatic fat content will be assessed by Fibroscan at baseline, 12, 18 and 30 weeks.
Change in the levels of cytokines
The levels of cytokines, including FGF21, adiponectin, A-FABP, LCN2, and others, will be assessed using Enzyme-Linked Immunosorbent Assay (ELISA) and other methods at baseline, 12, 18, and 30 weeks.
Change in immunologic function
The immunologic function will be assessed through isolation and analysis of peripheral blood mononuclear cells at baseline, 12, 18, and 30 weeks.
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