Impact of high intensity physical activity compared to routine counseling on renal function decline in patients with type 2 diabetes at high risk for kidney disease - the ACTIDIANE randomized controlled trial

BACKGROUND AND HYPOTHESIS: While physical activity (PA) is associated in observational studies with cardiovascular and renal protection few interventional studies have assessed its long-term effect on renal outcomes. This study is the first to specifically evaluate the impact of high-intensity PA on the slowing of renal function decline in type 2 diabetes (T2D) patients at high risk for kidney disease. METHODS: ActiDiaNe is an open, randomized controlled trial involving patients with T2D (pT2D) and rapid renal function decline (eGFR slope < -5 ml/min/year over 6-24 months). Participants were randomized to high-intensity PA (HIPA) or standard PA counseling (STPA) for two years. The primary endpoint was the slope of decline in cystatin C-derived eGFR (cys-eGFR). RESULTS: Across 21 centers, 178 patients were screened, 122 randomized, and 103 (29 women/74 men) analyzed for the primary endpoint (59 HIPA vs. 44 STPA). At baseline, mean age was 66 ± 8 years, median cys-eGFR was 54 ml/min/1.73m² (37; 65), and median eGFR decline was -9 ml/min/year (-12; -7). The primary endpoint showed a decline of -2.05 ml/min/year (95% CI: -3.46 to -0.64) in HIPA vs. -2.77 ml/min/year (95% CI: -4.40 to -1.14) in STPA (P = 0.512). Cardiovascular events and deaths occurred in 10 (17%) HIPA vs. 6 (14%) STPA patients (P = 0.646), with 3 deaths in HIPA (none of them protocol-related). Hypoglycemia was reported in 32 HIPA vs. 26 STPA patients (P = 0.623). CONCLUSION: In pT2D with rapid renal function decline, HIPA did not significantly alter renal function decline compared to STPA.