30% of patients with T2D have high levels of urine albumin at diagnosis: 75% MAU 25% overt diabetic nephropathy

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1 Identifying Patients with Type 2 Diabetes at High Risk of Microalbuminuria: the DEMAND (Developing Education on Microalbuminuria for Awareness of renal and cardiovascular risk in Diabetes) Study. Rossi Maria C.E, Nicolucci Antonio, De Cosmo Salvatore, Pellegrini Fabio, Ceriello Antonio, Cucinotta Domenico, Valentini Umberto, Vespasiani Giacomo, Comaschi Marco on behalf of Associazione Medici Diabetologi. Centro Studi e Ricerche Consorzio Mario Negri Sud

2 Background Microalbuminuria (MAU) represents a well known early marker of kidney damage as well as a strong predictor of cardiovascular events in both type1 and type 2 diabetes 30% of patients with T2D have high levels of urine albumin at diagnosis: 75% MAU 25% overt diabetic nephropathy 30-40% of patients with MAU develop overt diabetic nephropathy within 20 years from diabetes onset CMAJ 2002; 167: Diabetes Care2004; 27(suppl 1): 79-83

3 Aims To evaluate the prevalence of MAU in patients with T2DM in Italy To identify the correlates of MAU To identify specific subgroups of patients at particularly high risk for MAU

4 Enrollment 55 Italian Diabetes Outpatient Clinics 36 Patients/centre Enrollment duration: November 2004 May Selection of consecutive cases : FIRST WEEK: the first 6 eligible patients on Monday, Tuesday and Wednesday SECOND WEEK: the first 6 eligible patients on Monday, Tuesday and Wednesday 6

5 Eligibility Inclusion criteria Type 2 diabetes Age years Male or female Informed consent Exclusion criteria Other types of diabetes Menstrual cycle Urinary infections Overt diabetic nephropathy

6 Centralized Laboratory measurements Albuminuria/cretininuria ratio: Microalbuminuria = A/C ratio: mg/g Macroalbuminuria = A/C ratio: 300 mg/g Urinary infections: presence of nitrites or leucocytes 250 l/ml Patients enrolled 1874 Patients analyzed 1677 Urinary infections rate 10.5% (197 patients)

7 Results: prevalence of MAU 19.4% 3.6% Albuminuria Microalbuminuria (MAU) Normoalbuminuria 77.0% Microalbuminuria = A/C ratio: mg/g Macroalbuminuria = A/C ratio: 300 mg/g

8 Results: baseline characteristics Variables Normoalb. MAU p * Males 78.8% 21.2% Females 82.2% 17.8% 0.1 Age (yr) 62.9± ±9.2 < Diabetes duration (yr) 9.4± ±9.9 < HbA1c (%) 7.3± ±1.6 < Waist circumference Males Females 101.7± ± ± ± Smoke 76.7% 23.3% 0.37 Hypertension 14.4% 22.8% < Hyperlipidemia 19.5% 19.9% 0.8 Metabolic syndrome (ATP-III) 18.0% 22.6% 0.03 Retinopathy NO YES 82.8% 68.4% 17.2% 31.6% < Diabetic foot NO YES 80.6% 73.2% 19.4% 26.8% 0.17 Total CV complications NO YES 81.4% 75.0% 18.6% 25.0% 0.01

9 Results: multivariate analysis Covariates OR 95%CI Male Age HbA1c <7 7-8 > Diabetes treatment Diet and lifestyle Antidiabetic oral agents Antidiabetic oral agents + Insulin Insulin Systolic blood pressure (by 5 mmhg) Circumference waist (by 5 mmhg) Smoke NO EX YES HDL-cholesterol > < Retinopathy

10 Results: RECPAM analysis RECursive Partitioning and AMalgamation (RECPAM) To integrate the advantages of main effects logistic regression and tree growing techniques to explore the effect of interaction between independent variables. To identify distinct and homogeneous subgroups of patients with different risk of MAU. At each partitioning step the method chooses the variable and the level of splitting to maximize the difference in the outcome of interest, while adjusting for all other variables investigated. Patient age and systolic blood pressure served as the global predictors.

11 RECPAM analysis: prevalence of MAU <7 HbA1c > Retinopathy SI NO 71 > Waist circumference YES NO, EX >8 8 Waist circumference % Class % Class Smoke HbA1c 28.4% Class % Class 6 7.5% Class % Class % Class 2

12 RECPAM analysis: risk to present MAU <7 HbA1c > Retinopathy SI NO 71 > Waist circumference YES NO, EX >8 8 Waist circumference OR=3.41 Class 4 OR=3.03 Class Smoke HbA1c OR=4.83 Class 3 OR=3.27 Class 6 OR=1.00 Class OR=13.67 Class 1 OR=5.38 Class 2

13 Results: final multivariate analysis Covariates OR 95%CI Age SPB (by 5mmHg) Diabetes treatment Diet and lifestyle Antidiabetic oral agents Insulin Antidiabetic oral agents + Insulin HDL-cholesterol Recpam class > <

14 Conclusions In an Italian population with type 2 diabetes, the risk of MAU can vary by 10 times. The interaction between poor metabolic control, retinopathy and abdominal obesity, confers the highest risk of MAU. Good metabolic control associated with mild visceral obesity and no-smoking habit confers the lowest risk of MAU. Increasing age, high blood pressure and low HDLcholesterol levels further increase the risk of MAU in all the subgroups identified.