Achieving Diabetes Remission Through Dietary Intervention: A 12-Month Randomized Controlled Trial of Caloric-Carbohydrate Restriction in Overweight Patients With Early-Stage Type 2 Diabetes Mellitus

OBJECTIVE: We are aimed at evaluating the effects of a calorie-restricted low-carbohydrate diet (CR-LCD) on diabetes remission, weight control, and metabolic parameters in overweight patients with early-stage Type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: This 6-month randomized intervention trial with a 12-month follow-up randomly assigned 68 adults with early-stage T2DM to receive either a CR-LCD or a control diet. Of the original cohort, data from 66 participants (two dropouts in the CR-LCD group) were analyzed. The primary outcome was diabetes remission, defined as achieving a glycated hemoglobin (HbA1c) level < 6.5% without glucose-lowering medications; secondary outcomes included anthropometric, glycemic, and lipid parameters. RESULTS: The CR-LCD group had a significantly higher 6-month diabetes remission rate than the control group (62.50% vs. 35.29%, χ² = 4.885, p = 0.027). After multivariate adjustment, the intervention was associated with higher remission rates (odds ratio [OR] = 4.592, 95% confidence interval [CI]: 1.276-16.524; p = 0.020). At 12 months, between-group comparisons following false discovery rate (FDR) correction revealed significant differences in body mass index (FDR - adjusted p = 0.006, η²p = 0.150), waist circumference (FDR - adjusted p = 0.040, η²p = 0.085), fasting blood glucose (FDR - adjusted p < 0.001, r = 0.613), 2-h postprandial blood glucose (FDR - adjusted p = 0.040, η²p = 0.088), and high-density lipoprotein cholesterol (FDR - adjusted p = 0.040, η²p = 0.095). No severe adverse events were reported. CONCLUSIONS: A CR-LCD was effective in inducing diabetes remission in early-stage T2DM, suggesting that it may offer a viable nonpharmacological management strategy for this condition. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2600118189.