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

Both dapagliflozin alone and dapagliflozin plus nutritional intervention showed significant improvements over conventional care in glycaemic control and renal parameters.

• 108 patients with diabetic nephropathy (DN) were enrolled in a prospective, randomized, open-label trial.
• Patients were assigned to three groups: control group (CG, conventional care), treatment group (TG, CG + dapagliflozin 10 mg/day), or observation group (OG, TG + Mediterranean diet and oral nutritional supplements).
• Outcomes were assessed at baseline, 3 months, and 6 months.
• Both TG and OG showed significant improvements over CG in glycaemic control and renal parameters (P<0.05).

The observation group demonstrated greater reductions in HbA1c compared to the treatment group.

• HbA1c reduction was -1.5% in OG versus -0.9% in TG (P<0.05).
• OG also showed greater reductions in fasting blood glucose (FBG) and postprandial blood glucose (PBG) compared to TG.
• All glycaemic differences between OG and TG were statistically significant (P<0.05).

The observation group demonstrated greater reductions in urinary albumin-to-creatinine ratio (UACR) compared to the treatment group.

• UACR reduction was -48% in OG versus -35% in TG (P<0.05).
• Renal function parameters including BUN, sCr, UACR, and eGFR were assessed across groups.
• The difference in UACR reduction between OG and TG was statistically significant (P<0.05).

Nutritional markers improved significantly more in the observation group than in the treatment group.

• Albumin and ferritin levels improved significantly more in the OG compared to TG.
• Nutritional status was also assessed using the Subjective Global Assessment (SGA).
• The nutritional intervention consisted of a Mediterranean diet combined with oral nutritional supplements.

Quality of life as measured by SF-36 scores improved significantly more in the observation group.

• SF-36 scores improved significantly more in the OG compared to TG.
• Quality of life was assessed alongside safety, glycaemic control, renal function, nutritional status, and inflammation at baseline, 3 months, and 6 months.

Inflammatory markers decreased in both treatment groups, with a trend favoring the observation group.

• Inflammatory markers measured included CRP, TNF-α, and IL-6.
• Both TG and OG showed reductions in inflammatory markers compared to CG.
• A trend favoring OG over TG was observed for inflammatory marker reductions, though this did not reach the level of the other statistically significant findings reported.

Adverse event rates did not differ significantly among the three groups.

• Safety was assessed across CG, TG, and OG at baseline, 3 months, and 6 months.
• No significant difference in adverse event rates was found among the three groups.
• The addition of nutritional intervention to dapagliflozin did not increase the rate of adverse events.