Type 2 diabetes (T2DM) has become a major public health problem. Achieving remission (HbA1c\<6.5% without glucose-lowering medications) has recently become a new treatment goal. Low-calorie diets effectively induce remission, but adverse effects like fatigue, appetite, and constipation hinder success. Integrating traditional Chinese medicine (TCM) herbs into a low-calorie diet may alleviate adverse effects and improve remission rates.
This project investigates the efficacy of a Low-Calorie Medicine Diet (LCMD) in achieving T2DM remission among overweight/obese individuals through a randomized controlled trial. The investigators will explore individual differences in remission and elucidate the underlying biological mechanisms, focusing on the brain-gut-microbiota axis. By integrating nutrition and TCM dietetics, this project provides a novel, evidence-based approach to managing T2DM in Chinese populations.
Physician-diagnosed T2DM
The history of T2DM less than 6 years
Most recent HbA1c higher than 6.5%
Body mass index: 24-45 kg/m2
Type 1 diabetes, type 2 diabetes currently treated with insulin, or HbA1c ≥12%
Cardiovascular events within 6 months before trial
Current use of anti-obesity medications, eating disorders, dieting behaviors, or weight loss >5 kg within 6 months before trial
Chronic kidney disease stage 3b or above (eGFR <30 mL/min/1.73m²)
Parallel
Low-Calorie Medicine Diet
Combination productLow-Calorie Medicine Diet meals which are 815-835 kcal/day (approximately 43% carbohydrate, 29% protein, and 29% fat), combined with physical activity.
Low-Calorie Diet
Combination productLow-Calorie Diet meals which are 815-835 kcal/day (approximately 43% carbohydrate, 29% protein, and 29% fat), combined with physical activity.
Number of participants achieving diabetes remission as assessed by American Diabetes Association criteria
The proportion of participants achieving diabetes remission, which is defined as having a glycated hemoglobin (HbA1c) level less than 6.5% while receiving no pharmacological therapy for diabetes for at least 3 months.
Number of participants achieving significant weight loss, defined as a reduction of at least 12kg from baseline body weight
Proportion of participants achieving significant weight loss (≥12kg/10kg).
Change from baseline in insulin sensitivity as assessed by insulin tolerance test
Insulin sensitivity is evaluated with insulin tolerance tests at the pre-specified time points.
Change from baseline in beta cell function as assessed by arginine stimulation test
Beta cell function is evaluated with arginine stimulation test at the pre-specified time points.
Change from baseline in liver fat content and pancreatic fat content as assessed by magnetic resonance imaging
Liver and pancreatic fat will be assessed using magnetic resonance imaging (MRI) or proton magnetic resonance spectroscopy (1H-MRS). Liver fat content will be quantified as the proton density fat fraction (PDFF) in percentage, while pancreatic fat content will be expressed as the percentage of fat signal relative to the total signal in the region of interest (ROI).
Change from baseline in plasma glucose concentration
Glucose homeostasis parameters will be assessed, including fasting blood glucose (FBG) in mmol/L, postprandial blood glucose (PBG) in mmol/L 2 hours after a standardized meal, glycated hemoglobin (HbA1c) in percentage, and time in range (TIR), which represents the percentage of time that blood glucose levels remain within the target range (3.9-10.0 mmol/L) as assessed using continuous glucose monitoring (CGM) or self-monitoring of blood glucose (SMBG).
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