1. 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)
- Author
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Ruggenenti, P, Cortinovis, M, Trillini, M, Parvanova, A, Abbate, M, Satriano, C, Salvetti, F, Bossi, A, Trevisan, R, Perna, A, Peracchi, T, Rubis, N, Diadei, O, Martinetti, D, Gaspari, F, Fontana, L, Remuzzi, G, Ruggenenti P., Cortinovis M., Trillini M., Parvanova A., Abbate M., Satriano C., Salvetti F., Bossi A. C., Trevisan R., Perna A., Peracchi T., Rubis N., Diadei O., Martinetti D., Gaspari F., Fontana L., Remuzzi G., Ruggenenti, P, Cortinovis, M, Trillini, M, Parvanova, A, Abbate, M, Satriano, C, Salvetti, F, Bossi, A, Trevisan, R, Perna, A, Peracchi, T, Rubis, N, Diadei, O, Martinetti, D, Gaspari, F, Fontana, L, Remuzzi, G, Ruggenenti P., Cortinovis M., Trillini M., Parvanova A., Abbate M., Satriano C., Salvetti F., Bossi A. C., Trevisan R., Perna A., Peracchi T., Rubis N., Diadei O., Martinetti D., Gaspari F., Fontana L., and Remuzzi G.
- Abstract
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.
- Published
- 2022