Modification of diet in renal disease and Cockcroft-Gault formulas do not predict mortality (ZODIAC-6).

AIMS: An inverse relationship between estimates of renal function, with formulas such as the Modification of diet in renal disease (MDRD) study equation or the Cockcroft-Gault formula, and mortality has been suggested. These formulas both contain the variables sex, serum creatinine and age and the latter also contains body weight. We investigated whether these formulas predict mortality better than the variables they contain together in patients with Type 2 diabetes. METHODS: In 1998, 1143 primary care patients with Type 2 diabetes participated in the Zwolle Outpatient Diabetes project Integrating Available Care (ZODIAC) Study, in the Netherlands. Clinical and laboratory data were collected at baseline. Life status was assessed after 6 years. We used Cox proportional hazard modelling to investigate the association between estimates of renal function (continuous data) and the variables they contain and mortality, adjusting for confounders. Both formulas were compared with models consisting of the variables present in the formulas. Predictability was assessed using Bayesian information criterion (BIC) and Harrell's C statistics. RESULTS: At follow-up, 335 patients had died. All variables, except sex, influenced mortality. Predictive capability, indicated by lower BIC values and higher Harrell's C values, was up to 10% better for models containing the separate variables as compared with Cockcroft-Gault or MDRD. CONCLUSIONS: Using estimates of renal function to assess mortality risk decreases predictability as compared with the combination of the risk factors they contain. These formulas, therefore, could be used to estimate renal function; however, they should not be used as a tool to predict mortality risk.

Increased cancer mortality in type 2 diabetes (ZODIAC-3).

BACKGROUND: It is unclear whether there is a relationship between type two diabetes and cancer mortality. It also is unclear whether obesity and body mass index (BMI) are associated with cancer in type 2 diabetes patients. PATIENTS AND METHODS: In 1998, 1,145 patients with type two diabetes mellitus were enrolled in the Zwolle Outpatient Diabetes project Intergrating Available Care (ZODIAC) study. In this project, general practitioners (GPs) were assisted by hospital-based diabetes specialist nurses. Vital status was assessed in September 2004. The cancer mortality rate was evaluated using standardized mortality ratio (SMR) and its association with BMI (kg/m2) and obesity (>30 kg/m2) with the Cox proportional hazard ratio. RESULTS: The median follow-up time was 5.8 years. A total of 335 patients had died, of whom 70 died from malignancy. The SMR for cancer mortality was 1.38 (95% CI 1.07-1.75). BMI and obesity were not associated with cancer death. CONCLUSION: An increased cancer mortality rate was found in type two diabetes mellitus patients but there was no significant association between BMI or obesity and cancer mortality.

Intensification of therapy and no increase in body mass index with longer disease duration in type 2 diabetes mellitus (ZODIAC-5).

BACKGROUND: Decreased insulin sensitivity and beta-cell failure are the two key components in the pathogenesis of type 2 diabetes mellitus (T2DM). Secondary treatment failure is often attributed to the development of obesity-related insulin resistance in combination with continued loss of beta-cell function. OBJECTIVE: Assess metabolic control, body mass index (BMI) and treatment in relationship to diabetes duration to study these mechanisms. METHODS: Cross-sectional study of 7875 patients with T2DM in primary care in The Netherlands. Clinical data and laboratory results were obtained for the 2005 annual visit. Patients were grouped according to diabetes duration in 2-year intervals. Each step in the traditional treatment sequence was considered as a sign of progression of beta-cell failure. RESULTS: Complete data regarding duration and treatment were available for 6850 patients (87%). After the initial years following diagnosis, treatment with diet alone decreases and oral hypoglycaemic agents (OHA) are prescribed to an increasing percentage of patients. Treatment with OHA diminishes after approximately 10 years following diagnosis and treatment with insulin increases until approximately two-thirds of patients with diabetes duration of more than 20 years are being treated with insulin. BMI does not increase with longer disease duration. CONCLUSION: The concept of beta-cell failure as the primary determinant of the chronic progression of T2DM is supported by these results, whereas a deterioration of obesity-related insulin sensitivity as indicator is not supported.

Cross-sectional relationship between glycaemic control, hyperglycaemic symptoms and quality of life in type 2 diabetes (ZODIAC-2).

BACKGROUND: To describe the relationship between glycaemic control, hyperglycaemic symptoms and quality of life (HRQOL) in type 2 diabetic patients. METHODS: In a shared-care diabetes project HRQOL was assessed. A total of 1664 patients with type 2 diabetes were identified in 32 primary healthcare practices. Of these patients, 1149 were included. HRQOL was measured using a generic questionnaire (Rand-36), completed by 1006 of the 1149 participants. RESULTS: The number of hyperglycaemic symptoms was higher in women (1.88) compared with men (1.64), without differences in mean haemoglobin A1c (HbA1c) (7.5%)-Univariate analyses showed negative relationships between all dimensions of the Rand-36 and hyperglycaemic symptoms (p<0.001), but between only one dimension and HbA1c (p=0.005). Multivariate analyses showed no association between any of the dimensions of the Rand-36 and HbA1c, but the relationship between hyperglycaemic symptoms persisted in all dimensions (p<0.001). Notwithstanding these results, the presence of hyperglycaemic symptoms was related to higher HbA1c. CONCLUSION: In type 2 diabetic patients, as assessed by a generic questionnaire, there is an evident relationship between hyperglycaemic symptoms and HRQOL and not between HbA1c and HRQOL. Subjective hyperglycaemic symptoms are, independent of HbA1c, important for HRQOL in type 2 diabetic patients, and should therefore not be neglected in the management of diabetes.

Shared care with task delegation to nurses for type 2 diabetes: prospective observational study.

BACKGROUND: To study the effects of two different structured shared care interventions, tailored to local needs and resources, in an unselected patient population with type 2 diabetes mellitus. METHODS: A three-year prospective observational study of two interventions and standard care. The interventions involved extensive (A) or limited (B) task delegation from general practitioners to hospital-liaised nurses specialised in diabetes and included a diabetes register, structured recall, facilitated generalist-specialist communication, audit and feedback, patient-specific reminders, and emphasised patient education. The target population consisted of 2660 patients with type 2 diabetes treated in the primary care setting. Patients who were terminally ill or who had been diagnosed with dementia were excluded from the study. RESULTS: The participation rates were high (90%) for patients, and none of the 64 GPs discontinued their participation in the study. Longitudinal analyses showed significant improvements in quality indicators for both intervention groups (process parameters and achieved target values on the individual patient level); in standard care, performance remained stable or deteriorated. Both patients and caregivers appeared satisfied with the project. CONCLUSION: This study shows that structured shared care with task delegation to nurses, targeted at a large unselected general practice population, is feasible and can positively affect the quality of care for patients with type 2 diabetes.

[Microalbuminuria in patients with type 2 diabetes mellitus in general practice]. / Microalbuminurie bij patiënten met diabetes mellitus type 2 in de huisartspraktijk.

OBJECTIVE: Determine the prevalence of microalbuminuria in patients with type 2 diabetes mellitus (DM) in general practice, as an independent risk factor for cardiovascular diseases. DESIGN: Prospective, descriptive. METHOD: Data were collected on patients with type 2 DM in the Zwolle region of the Netherlands, all of whom were being treated by their general practitioner. The inclusion period was 1 February 2000-31 January 2001. The study formed part of a larger investigation, in which the albumin concentration in a urine sample and the albumin-creatinin ratio were determined once per year. A total of 32 general practitioners took part in the study. RESULTS: In the general practices studied, 2094 patients were known with type 2 DM and 1653 (79%) were treated exclusively by the general practitioner. Of these 1653 patients, 67 (4%) were excluded and of the 1586 invited patients remaining, 1441 (91%) participated. Microalbuminuria was present in 33% of the patients and macroalbuminuria in 7% of the patients, and the prevalences increased with age: < 50, 50-70 and > 70 years. 18% (6/33) of the patients aged < 50 years with microalbuminuria were treated with an ACE inhibitor or angiotensin II antagonist compared to 33% (183/548) of patients > or = 50 years. 91% (488/539) of the patients > or = 50 years with microalbuminuria had hypertension and/or lipid profile abnormalities and 82% (402/488) of them were not treated or did not receive adequate treatment for this condition. CONCLUSION: Microalbuminuria and macroalbuminuria were present in respectively 33% and 7% of the patients with type 2 DM in primary care. The treatment of hypertension and lipid profile abnormalities was often inadequate. Therefore, screening patients aged 50 years and older with type 2 DM for albuminuria is justified.

[Relatively poor regulation of blood pressure in patients with type-2 diabetes mellitus in the primary care setting and specialists' practice in the Netherlands]. / Matige bloeddrukregulatie bij patiënten met diabetes mellitus type 2 in de eerste en tweede lijn.

OBJECTIVE: To investigate the degree to which the goals for adequate blood-pressure control in patients with type-2 diabetes mellitus (DM) are met in Dutch specialists' practice and in the primary-care setting. DESIGN: Cross sectional. METHOD: Data were collected from all consecutive patients with DM type 2 visiting the outpatient clinic of two physicians specialised in diabetes care, in Zwolle, the Netherlands, in the period 1 November 1999-30 April 2000. The target value for blood pressure was < or = 150/85 mmHg. In addition, baseline data were collected on patients in the primary-care setting who participated in a transmural project in Zwolle in the period 1 February 1997-31 January 1998. In 1998, the target blood pressure in the primary-care setting was < or = 160/90 mmHg. Patients who met the goals for adequate blood-pressure control were compared with patients who did not. RESULTS: A total of 502 patients from specialists' practice and 1084 patients from the primary-care setting were included. The prevalence of hypertension in specialists' practice was 89% (n = 377); of these patients, 140 (37%) had a good regulation of their blood pressure. The patients who had an adequate blood-pressure control and those who did not were comparable. Both groups were prescribed an average of 2.2 kinds of antihypertensive agent per patient. The prevalence of hypertension in the primary care was 69% (n = 733). The goal for adequate blood-pressure control, i.e. a blood pressure of < or = 160/90 mmHg, was achieved in 44% (n = 324). In the primary-care setting, an average of 1.1 kinds of antihypertensive agent was prescribed, 1.6 in patients who achieved the target value and 0.8 in those who did not (p < 0.05). CONCLUSION: Regulation of blood pressure in patients with type 2 DM and hypertension was far from optimal: 37% of patients in specialists' practice and 44% of those in the primary-care setting achieved the target values.

Prevalence, incidence and mortality of type 2 diabetes mellitus revisited: a prospective population-based study in The Netherlands (ZODIAC-1).

BACKGROUND: To present actual data to estimate prevalence, incidence and mortality of known type 2 diabetes mellitus in all age categories in The Netherlands. METHODS: Prospective population-based study between 1998 and 2000 in The Netherlands. Baseline population of 155,774 patients, registered with 61 general practitioners participating in the Zwolle Outpatient Diabetes project Integrating Available Care (ZODIAC)-study. RESULTS: Age- and sex-adjusted prevalence of type 2 diabetes was 2.2% at baseline and 2.9% after 2 years of follow-up; for women and men it was 3.1 and 2.7% at follow-up, respectively. Patients aged >70 years account for almost 50% of all type 2 diabetes patients. Age- and sex-adjusted mean annual incidence per 10,000 over 3 years was 22.7 overall; for women 23.1 and for men 22.2. Incidence--even though high--decreases after the age of 70 years. The mortality rate was 47.9/1000 and standardised mortality ratio 1.40. Based on these results, the estimated total number of subjects known with type 2 diabetes was 466,000 for The Netherlands in 2000; the number of patients with newly diagnosed diabetes 36,000. CONCLUSIONS: Prevalence and incidence rates exceed all estimates regarding known type 2 diabetes for The Netherlands. Elderly patients, aged 70 years and over, account for 50% of the type 2 diabetic population. These results are important for health-care planning.

[Recommendations concerning the initial regimen and dose adjustments of insulin therapy for type 2 diabetes mellitus]. / Aanbevelingen voor het instellen en aanpassen van insulinetherapie bij diabetes mellitus type 2.

Although physicians are confronted with an increasing number of insulin-treated patients with type 2 diabetes mellitus, guidelines for the initial insulin regimen and dose adjustment are rare. If the fasting blood glucose level is > 10 mmol/l and the postprandial values are not much higher than the fasting ones, then the patient can be started on 8-12 IU of an intermediate-acting insulin before going to sleep. In the case of blood glucose levels which increase during the day or if a single insulin dose has insufficient effect, the patient can be started on a twice-daily administration of a premixed insulin. If more than 40 IU of insulin per injection are needed to regulate the blood glucose levels, it might be necessary to switch to administering insulin 4 times per day. Of this total daily quantity, initially 20% is administered as (ultra)short-acting insulin before the three daily meals and 40% as a bedtime intermediate-acting insulin. Occasionally elevated blood glucose levels do not necessarily have to be a reason for adjusting the insulin dosage.