2026-04-29T22:57:42Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/234742024-10-04T13:46:18Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16967

00925njm 22002777a 4500 dc Ruggenenti, Piero author Cortinovis, Monica author Trillini, Matias author Parvanova, Aneliya author Abbate, Manuela author Satriano, Chiara author Salvetti, Ferdinando author Bossi, Antonio C author Trevisan, Roberto author Perna, Annalisa author Peracchi, Tobia author Rubis, Nadia author Diadei, Olimpia author Martinetti, Davide author Gaspari, Flavio author Fontana, Luigi author Remuzzi, Giuseppe author CRESO 2 Study Organization author 2022-03 Aims: In type 2 diabetic patients with obesity, hyperfiltration is a risk factor for accelerated glomerular filtration rate (GFR) decline and is ameliorated by calorie restriction (CR). We assessed whether CR-induced amelioration of hyperfiltration could translate into slower long-term GFR decline in this population. Methods: In this academic, single-center, parallel-group, prospective, randomized, open-label, blinded endpoint trial, consenting >40-year-old patients with type 2 diabetes, BMI ≥27 kg/m2, creatinine <1.2 mg/dL and albuminuria ≤300 mg/24 h were randomized (1:1) to two-year 25% CR (n = 53) or standard diet (SD, n = 50). Primary outcome was 6-month measured GFR. Analyses were by modified intention-to-treat. Results: At 6 months GFR decreased by 5.16 ± 10.03 mL/min (P = 0.001) with CR, and by 0.98 ± 9.71 mL/min (P = 0.497) with SD. Between-group difference was significant (P = 0.044). GFR decline from 6 to 24 months was significant with SD (P < 0.01), but not with CR (P = 0.075). Between-group difference, however, was not significant (P = 0.414). Body weight, BMI, waist circumference, systolic blood pressure, HbA1c, blood glucose, serum triglycerides decreased and ApoA-I concentration increased with CR. No changes were observed with SD. Between-group differences were significant. CR was tolerated well. Conclusions: In obese type 2 diabetic patients, CR ameliorated glomerular hyperfiltration and several cardiovascular risk factors, and blunted long-term GFR decline. Trial registration: NCT01930136. Ruggenenti P, Cortinovis M, Trillini M, Parvanova A, Abbate M, Satriano C, et al. Long-term kidney and systemic effects of calorie restriction in overweight or obese type 2 diabetic patients (C.Re.S.O. 2 randomized controlled trial). Diabetes Res Clin Pract. 2022 Mar;185:109804. Epub 2022 Feb 24. 10.1016/j.diabres.2022.109804 1872-8227 Diabetes Research and Clinical Practice https://hdl.handle.net/20.500.13003/19669 35219762 L2017098851 2-s2.0-85125557637 https://hdl.handle.net/20.500.12105/23474 810140100004 Calorie restriction Cardiovascular risk Nephropathy Obesity Type 2 diabetes Long-term kidney and systemic effects of calorie restriction in overweight or obese type 2 diabetic patients (C.Re.S.O. 2 randomized controlled trial)