Adjunctive nutritional intervention improves glycaemia and quality of life in dapagliflozin-treated diabetic patients

Objectives: This study aimed to evaluate the added benefits of a structured nutritional intervention combined with dapagliflozin in patients with DN. Methods: In this prospective, randomized, open-label trial, 108 patients with DN were assigned to a control group (CG, conventional care), a treatment group (TG, CG + dapagliflozin 10 mg/day), or an observation group (OG, TG + Mediterranean diet and oral nutritional supplements). Key outcomes included glycaemic control (FBG, PBG, HbA1c), renal function (BUN, sCr, UACR, eGFR), nutritional status (albumin, ferritin, SGA), inflammation (CRP, TNF-?, IL-6), safety and quality of life (SF-36), assessed at baseline, 3 and 6 months. Results: Both TG and OG showed significant improvements over CG in glycaemic control and renal parameters (P<0.05). The OG demonstrated superior outcomes compared to TG: greater reductions in HbA1c (-1.5% vs. -0.9%), FBG, PBG and UACR (-48% vs. -35%) (all P<0.05). Nutritional markers (albumin, ferritin) and SF-36 scores improved significantly more in the OG. Inflammatory markers decreased in both treatment groups, with a trend favoring OG. Adverse event rates did not differ significantly among groups. Conclusion: Adjunctive nutritional intervention significantly enhances the glycaemic, renal, nutritional and quality-of-life benefits of dapagliflozin in patients with DN, offering a promising integrated therapeutic strategy.