Renal and Systemic Effects of Calorie Restriction in Patients With Type 2 Diabetes With Abdominal Obesity: A Randomized Controlled Trial.

In individuals with type 2 diabetes with abdominal obesity, hyperfiltration is a risk factor for accelerated glomerular filtration rate (GFR) decline and nephropathy. In this academic, single-center, parallel-group, prospective, randomized, open-label, blinded end point trial, consenting patients with type 2 diabetes aged >18 years, with waist circumference >94 (males) or >80 (females) cm, serum creatinine <1.2 mg/dL, and normoalbuminuria were randomized (1:1) with permuted blocks to 6 months of a 25% calorie restricted (CR) or standard diet (SD). Primary outcome was measured GFR (iohexol plasma clearance). Analyses were by modified intention to treat. At 6 months, GFR significantly decreased in 34 patients on CR and did not change appreciably in 36 on SD. Changes were significantly different between the groups. GFR and body weight reduction were correlated. GFR reduction was larger in hyperfiltering (GFR >120 mL/min) than nonhyperfiltering patients and was associated with BMI, waist circumference, blood pressure, heart rate, HbA1c, blood glucose, LDL-to-HDL cholesterol ratio, C-reactive protein, angiotensin II, and albuminuria reduction and with increased glucose disposal rate (measured by hyperinsulinemic-euglycemic clamps). Protein and sodium intake and concomitant treatments were similar between the groups. CR was tolerated well. In patients with type 2 diabetes with abdominal obesity, CR ameliorates glomerular hyperfiltration, insulin sensitivity, and other cardiovascular risk factors, effects that might translate into long-term nephro- and cardioprotection.

RCT Entities:   Population Interventions Outcomes