ArticlesIntensified multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: the Steno type 2 randomised study
Introduction
Although macrovasular events cause most deaths in patients with type 2 diabetes, there is a great demand on health resources to manage the microvascular complications. Many patients develop retinopathy and neuropathy and type 2 diabetes is a principal cause of end-stage renal disease.1 Some of the risk factors of microvascular complications are modifiable and a multifactorial approach has been suggested.
Our randomised trial was designed to find out whether intensive multifactorial intervention that includes changes in behaviour and pharmacological therapy, slows the initiation and progression of microvascular complications in microalbuminuric patients with type 2 diabetes compared with a standard multifactorial treatment. Patients with microalbuminuria were selected since this is a strong predictor for the development of both microvascular and macrovascular complications.2, 3 Each year, 4–8% of patients with microalbuminuria have progression of their retinopathy or progression to nephropathy.1, 4
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Patients
All patients were recruited from the Steno Diabetes Center during 1992–93. 315 patients who had urine albumin excretion rates (AER) of 30–300 mg in a 24 h urine sample were eligible. Patients were then asked to collect six 24 h urine samples. We defined microalbuminuria for this study as an AER of 30–300 mg per 24 h in four of these six samples: these criteria were used to improve the specificity of the diagnosis. Diabetes was diagnosed by 1985 WHOcriteria. The exclusion criteria were: age
Results
The flow of patients in the study is shown in figure 1. No patients were at any time excluded because of unwillingness to adhere to the assigned treatments. Clinical and biochemical characteristics of the 160 patients assigned standard or intensive treatment are in table 3. The medications taken by the participants are shown in table 2.
The mean (SD) follow-up was 3·8 (0·3) years. The changes in lifestyle, biochemistry in the two groups at the end of the study and differences between groups are
Discussion
We found that nearly 4 years of intensive multifactorial treatment slowed the progression to nephropathy and progression of retinopathy and autonomic neuropathy in our patients with type 2 diabetes and microalbuminuria—most of whom were obese.
By comparison, the impact of intensive antihyperglycaemic treatment on the progression from microalbuminuria to overt nephropathy in type 1 diabetes mellitus is controversial.14, 15, 16, 17, 18 An analysis of all 218 patients with type 1 diabetes patients
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