Effect of the Mediterranean diet in combination with exercise on metabolic syndrome parameters: 1-year randomized controlled trial.

This work aimed to evaluate and compare the benefits of the energy restricted Mediterranean diet (MD) and Standard hypolipemic diet (SHD) accompanied by exercise on metabolic syndrome parameters. A 12-month, randomized, single-blinded, diet-controlled study was conducted on 124 obese participants in the University Hospital Dubrava. Participants were assigned to the MD (n = 63) or the SHD (n = 61) and received the same amount of nutritional education and guidance on physical activity. The completion rate was 67.7 %. Both diets produced significant beneficial changes in body weight and waist circumference (P < 0.001 for MD and SHD). Compared with the SHD, HDL cholesterol increased (P = 0.031) and systolic blood pressure (SBP) decreased (P = 0.020) in the MD group. Fasting plasma glucose decreased significantly in both diet groups (P < 0.001 for MD; P = 0.026 for SHD). Although both diets accompanied by physical activity yielded similar weight reduction results, adherence to the MD was associated with more prominent reduction of the MetS components, namely HDL level elevation and SBP reduction.

The Effect of the Mediterranean Diet on Serum Total Antioxidant Capacity in Obese Patients: A Randomized Controlled Trial.

OBJECTIVE: The aim of this work was to evaluate the combined effect of physical activity and 1 and 12 months' adherence to Mediterranean diet (MD) on serum total antioxidant capacity (TAC) in obese patients, as well as factors contributing to TAC. METHODS: One hundred twenty-four patients were randomly assigned to either MD combined with physical activity or standard hypolypemic diet (SHD) with physical activity. Both groups received counseling and education during the initial week and were invited for the follow-up visits, where data on body weight and blood samples were collected. TAC was determined by Trolox equivalent antioxidant capacity and urate was determined using a uricase spectrophotometric method at the initial visit and after 1 and 12 months. RESULTS: Eighty-four patients finished the 12-month program and were analyzed. The baseline and 1- and 12-month mean (±SD) TAC values in the MD group (n = 40) were 2.38 ± 0.48, 2.51 ± 0.47, and 2.47 ± 0.45 mmol Trolox equivalent (TE)/L, respectively. In the SHD group (n = 44), TAC values were 2.37 ± 0.49, 2.48 ± 0.49, and 2.31 ± 0.51 mmol TE/L, respectively. There was a statistically significant main effect for time (p < 0.001), as well as statistically significant time-diet interaction effect (p = 0.009). There was no statistically significant correlation between TAC and uric acid after 1 month (p = 0.733) or 12 months (p = 0.844) of the intervention. Based on the regression model, which included gender, diet, physical activity level, and percentage body weight change, the type of diet was the only significantly contributing factor to TAC change after the 12-month period, F = 3.867, df = 3, p = 0.012, R = 0.358, R(2) = 0.128. CONCLUSION: This randomized controlled trial with diet and physical activity intervention and TAC as a primary outcome demonstrated initial antioxidant improvement in both MD and SHD groups and a long-term beneficial effect of MD. The results imply that diet composition-olive oil, nuts, and fish in particular-combined with physical activity modify antioxidant capacity.

[CROATIAN GUIDELINES FOR THE PHARMACOTHERAPY OF TYPE 2 DIABETES]. / HRVATSKE SMJERNICE ZA FARMAKOLOSKO LIJECENJE SECERNE BOLESTI TIPA 2.

INTRODUCTION: The Croatian Association for Diabetes and Metabolic Disorders of the Croatian Medical Association has issued in 2011 the first national guidelines for the nutrition, education, self-control, and pharmacotherapy of diabetes type 2. According to the increased number of available medicines and new evidence related to the effectiveness and safety of medicines already involved in the therapy there was a need for update of the existing guidelines for the pharmacotherapy of type 2 diabetes in the Republic of Croatia. PARTICIPANTS: as co-authors of the Guidelines there are listed all members of the Croatian Association for Diabetes and Metabolic Diseases, as well as other representatives of professional societies within the Croatian Medical Association, who have contributed with comments and suggestions to the development of the Guidelines. EVIDENCE: These guidelines are evidence-based, according to the GRADE system (eng. Grading of Recommendations, Assessment, Development and Evaluation), which describes the level of evidence and strength of recommendations. CONCLUSIONS: An individual patient approach based on physiological principles in blood glucose control is essential for diabetes' patients management. Glycemic targets and selection of the pharmacological agents should be tailored to the patient, taking into account the age, duration of disease, life expectancy, risk of hypoglyce- mia, comorbidities, developed vascular and other complications as well as other factors. Because of all this, is of national interest to have a practical, rational and applicable guidelines for the pharmacotherapy of type 2 diabetes.

Red blood cell distribution width as a prognostic marker of mortality in patients on chronic dialysis: a single center, prospective longitudinal study.

AIM: To determine if red cell distribution width (RDW) is associated with all-cause mortality in patients on chronic dialysis and to evaluate its prognostic value among validated prognostic biomarkers. METHODS: This is a single center, prospective longitudinal study. At the time of inclusion in January 2011, all patients were physically examined and a routine blood analysis was performed. A sera sample was preserved for determination of NT-pro-brain natriuretic peptide (NT-pro-BNP) and eosinophil cationic protein. Carotid intima media thickness (IMT) was also measured. Following one year, all-cause mortality was evaluated. RESULTS: Of 100 patients, 25 patients died during the follow-up period of one-year. Patients who died had significantly higher median [range] RDW levels (16.7% [14.3-19.5] vs 15.5% [13.2-19.7], P<0.001. They had significantly higher Eastern Cooperative Oncology Group (ECOG) performance status (4 [2-4] vs 2 [1-4], Plt;0.001), increased intima-media thickness (IMT) (0.71 [0.47-1.25] vs 0.63 [0.31-1.55], P=0.011), increased NT-pro-BNP levels (8300 [1108-35000] vs 4837 [413-35000], P=0.043), and increased C-reactive protein (CRP) levels (11.6 [1.3-154.2] vs 4.9 [0.4-92.9], Plt;0.001). For each 1% point increase in RDW level as a continuous variable, one-year all cause mortality risk was increased by 54% in univariate Cox proportional hazard analysis. In the final model, when RDW was entered as a categorical variable, mortality risk was significantly increased (hazard ratio, 5.15, 95% confidence interval, 2.33 to 11.36) and patients with RDW levels above 15.75% had significantly shorter survival time (Log rank Plt;0.001) than others. CONCLUSIONS: RDW could be an additive predictor for all-cause mortality in patients on chronic dialysis. Furthermore, RDW combined with sound clinical judgment improves identification of patients who are at increased risk compared to RDW alone.

The relationship between methylenetetrahydrofolate reductase C677T gene polymorphism and diabetic nephropathy in Croatian type 2 diabetic patients.

Methylenetetrahydrofolate reductase (MTHFR) polymorphism has been shown to be associated with the development of diabetic nephropathy in many ethnic groups. In this study, we examined the correlation between MTHFR C677T polymorphism and microalbuminuria in patients with diabetes mellitus type 2 in Croatian patients. 85 patients with diabetes mellitus type 2 were recruited. Patients were classified into two groups--with and without diabetic nephropathy according to urinary albumin excretion rate in urine collected during 24 hours. The C677T genotype was determined by real-time PCR analysis. The genotype frequencies were CC 36.5%, CT 42.3% and TT 21.2% in diabetic patients without nephropathy versus CC 39.4%, CT 45.4% and TT 15.2% in those with nephropathy. There was no statistically significant difference in allele distribution between patients with nephropathy and those without (p = 0.788). Our study did not show a correlation between mutations in the MTHFR gene and diabetic nephropathy in Croatian patients. Diabetic nephropathy is influenced by multiple risk factors which can modify the importance of MTHFR polymorphism in its development.

The antioxidative protecting role of the Mediterranean diet.

Recent meta-analysis shows that adherence to a Mediterranean diet (MD) can significantly decrease the risk of overall mortality, mortality from cardiovascular diseases, as well as incidence of mortality from cancer, and incidence of Parkinson's and Alzheimer's disease. All of these diseases could be linked to oxidative stress (OS) as antioxidative effect of MD is getting more attention nowadays. Although a lot of research has been done in this area and it suggests antioxidative protective role of MD, the presented evidence is still inconclusive. The aim of this paper is to review studies investigating the effect of MD on OS, as well as to identify the areas for further research.

Effect of American ginseng (Panax quinquefolius L.) on glycemic control in type 2 diabetes.

Since diabetes tends to progressively worsen over time, glycemic control often deteriorates in spite of taking regular therapy. Therefore, numerous research studies are by and large focused on finding more efficient therapy, both new medicines for treating type 2 diabetes mellitus, as well as supplements that could serve as an addition to conventional treatment modalities. A variety of herbal preparations have been shown to have modest short-term beneficial effects on glycemia, but of these, the best studied is American ginseng (AG). AG has been shown to be effective in improving glycemic control in type 2 diabetes through increasing post-prandial insulin levels and decreasing postprandial glycemic response. However, high variability in ginsenosides may result in just as high variability in antidiabetic efficacy of over-the-counter ginseng products. Therefore, the availability of standardized extracts of AG could assist greatly in advancing our knowledge on the role of this traditionally used herb and result in a wider application of ginseng product in diabetes management. The aim of this review is to outline the efficacy and safety of American ginseng for AG preparations on glycemic control in patients with type 2 diabetes as well as to increase awareness of the evidence supporting the use of these therapies in diabetes care.

The jubilees of the discovery of insulin & glycemic index: where conventional meets complementary medicine in the management of diabetes mellitus.

This year we marked two important jubilees in the management of diabetes mellitus: one is the discovery of insulin 90 years ago and the other one is the introduction of the Glycemic Index, 60 years later, both originated at the University of Toronto, Canada. Both discoveries can help to improve diabetes tremendously and thus have contributed to the advancement of management of this troubling disease the incidence of which continues to climb at a staggering rate.

Glycemic index in diabetes.

The Glycemic Index (GI) is a rating system that ranks carbohydrate-containing foods according to their postprandial blood glucose response relative to the same quantity of available carbohydrate of a standard such as white bread or glucose. The concept of GI was first introduced in the early 80's by Jenkins and coworkers. Since then, numerous trials have been undertaken, many indicating benefits of a low GI diet on glycemic control, as well as lipid profiles, insulin and C-peptide levels, inflammatory and thrombolytic factors, endothelial function and regulation of body weight. As a result, a low-GI diet may prevent or delay the vascular complications of diabetes. However, despite many studies supporting the benefits of the Glycemic Index as part of the treatment of diabetes mellitus, several areas of controversy have been raised in the literature and are addressed here. Clinicians treating diabetic patients should be aware of the potential benefits of low-GI foods in the prevention and treatment of diabetes and its complications.

Carotid endarterectomy unexpectedly resulted in optimal blood pressure control.

Resistant hypertension is defined as hypertension that remains above 140/90 mmHg despite the provision of three or more antihypertensive drugs in a rational combination at full doses and including a diuretic. It is associated with adverse clinical outcome and therefore requires aggressive medical treatment. We present a case of 70-year-old woman who was treated for resistant hypertension with a diuretic, ACE-inhibitor, calcium channel blocker, and with centrally acting antihypertensive, moxonodine. Despite of aggressive medical treatment her blood pressure remained above 160/90 mmHg continuously. Large diagnostic workup excluded common causes of secondary hypertension, but revealed significant carotid stenosis present on left internal carotid artery. Carotid endarterectomy was performed in order to improve cerebrovascular prognosis, but unexpectedly resulted in optimal control of her blood pressure. Two months after operation patient was on only one antihypertensive drug, having blood pressure below 130/85 mmHg. We suggest that in selected patients resistant hypertension could be associated with carotid stenosis and carotid sinus baroreceptor dysfunction. For definite conclusions further studies are warranted.

[Diabetes and acute coronary syndrome]. / Pristup dijabetickom bolesniku s akutnim koronarnim sindromom.

Diabetes mellitus has a major impact on cardiac morbidity and mortality with three major aspects of the relationship: (I) coronary multiple thickening and its consequences, (2) autonomic neuropathy of the heart, and (3) cardiomyopathy. It is well established that diabetic patients are more likely than patients without diabetes to die after an acute coronary syndrome (ACS). The increased mortality is seen both in the acute phase and during long term follow up. The unfavorable prognosis of diabetic patients has mainly been attributed to more pronounced left ventricular dysfunction and a high likelihood of reinfarction. Many factors may contribute to this unfavorable outcome, such as severe diffuse coronary artery disease, disturbed autonomic tone, diabetic cardiomyopathy, and abnormal platelet activation and thrombin-generation that are pronounced in diabetes, as well as purely metabolic factors causing more oxygen consuming use of free fatty acids during acute myocardial ischemia. There are many evidence-based interventions in ACS patients that are applicable to diabetic patients with ACS, and there are no specific contraindications to evidence-based therapies in patients with diabetes; thrombolysis and the use of beta-blockers should be used alongside other evidence-based therapies. The role of intensive intravenous insulin in diabetic patients with ACS remains to be clarified.

Comparable postprandial glucose reductions with viscous fiber blend enriched biscuits in healthy subjects and patients with diabetes mellitus: acute randomized controlled clinical trial.

AIM: To compare the blood glucose-lowering effect of a highly viscous fiber blend (VFB) added to a starchy snack on postprandial glycemia between healthy participants and participants with diabetes mellitus. METHODS: Ten healthy participants (4 men and 6 women, aged 28+/-2.6 years, body mass index [BMI], 24.3+/-0.8 kg/m(2)) and 9 participants with diabetes mellitus type 2 (3 men and 6 women, aged 68+/-3.8 years, BMI 28.8+/-1.2 kg/m(2)) on four separate occasions took either 50 g available carbohydrates as control biscuits, biscuits with 10 g of highly viscous fiber blend, white bread with 12 g of margarine, or white bread alone. Postprandial blood glucose response, glycemic index (GI), and palatability were determined. RESULTS: Mean (95% confidence interval) GI values of the viscous fiber blend biscuits were 26 (16-36) and 37 (27-47) GI units for healthy participants and participants with diabetes mellitus, respectively. These values were significantly lower than those of white bread, white bread with 12 g of margarine, and control biscuits (P<0.001, paired t test) both in healthy participants (GI 100, 108 [57-159], and 101 [44-158], respectively) and participants with diabetes mellitus (GI 100, 103 [79-127], and 94 [78-110], respectively). Viscous fiber blend significantly reduced the glycemic index by 74% (7.4 GI units/g of fiber) in healthy participants and by 63% (6.3 GI units/g of fiber) in participants with diabetes. The GI did not differ between control meals in both healthy participants and participants with diabetes. There were no significant differences in palatability among the types of meals, although participants with diabetes found the viscous fiber blend biscuits more palatable (P=0.002, t test). CONCLUSION: Viscous fiber blend is a very potent and palatable soluble fiber addition to a starchy snack, which is able to reduce the glycemic response to a similar extent in both healthy participants and individuals with diabetes mellitus. Biscuits with low GI, and possibly other viscous fiber blend fortified starchy foods, may potentially be a useful replacement of high GI snack foods in the diet.

Prescribing medication errors in hospitalised patients: a prospective study.

The aims of this prospective study were to determine the incidence and types of prescribing medication errors and ways to prevent them from reaching patients. Data were collected from 4951 prescriptions over a 25 week period in 2002. Medication errors were classified as: incorrect dose, incorrect dose interval, duplication of therapy and drug interactions. The medical record analysis was used to compare prescribing with Croatian literature drug data and AHFS first Web version 2 (American Society of Health System Pharmacists). The incidence of medication errors in the entire sample, including all potential drug interactions, was 14.7%. However, as only 8 interactions (out of 356 potentially possible interactions) were assessed as clinically significant, then the total number of all types of medication errors was 379. This resulted in an incidence of 7.7%. Dosage errors were the most frequent errors, followed by incorrect interval, drug duplication and drug interaction. The difference between the incidence of potentially possible and clinically significant drug interactions was quite large (7.2 vs. 0.2%). Thus, a critical attitude is necessary when evaluating available data on drug interactions. Our findings point to the need of systematic control of prescribed therapies, which could be ensured by the application of the Unit Dose Drug Distribution System. A medication errors reporting program should be established both at the hospital and at national levels in Croatia.

[Acute coronary syndrome in diabetes]. / Akutni koronarni sindrom secernoj bolesti.

Diabetes mellitus is a metabolic disease with explicit complications on coronary vascular system. The incidence of coronary disease is rising in type 1 as well as in type 2 diabetes mellitus, and it is caused by precipitating atherosclerosis. It is unquestionable that disorders of different metabolic pathways cause acute coronary syndrome, the same holding true for postinfarction complications. Strict blood glucose control (glucose value should be close to the physiologic values) is imperative not only in the prevention but also in the treatment of acute coronary syndrome and prevention of reinfarction. It is obvious that medicamentous and surgical treatment of coronary heart disease in diabetic patients can reduce morbidity and mortality. The treatment of acute coronary heart syndrome in diabetic patients is very similar to that in nondiabetic patients, however, it demands extra efforts to establish good metabolic control. Due to more than one narrowing of coronary arteries in diabetic patients, angioplasty is often less efficient and there is a need of specific evaluation by a cardio-cardio surgical team to choose the method of treatment: stent implantation or arterial bypass. The strategy of optimal revascularization for diabetic patients who have multivascular coronary heart disease is still controversial. Although data on early percutaneous or surgical revascularization show longterm benefit, the early studies were carried out before the extensive use of intracoronary stents and thrombocyte inhibitors GP IIb/IIa. A dilemma about this question showed up when excellent results of drug eluting intracoronary stents brought up credibility of compared studies. For best patient selection, it has been recommended that decision should be based more on coronary anatomy rather than the presence or absence of diabetes mellitus. Surgical revascularization (CAGB) should be considered in patients with diabetes mellitus who have stenosis of the left main coronary artery, significant diffuse stenosis involving each of epicardial vessels, and patients who have mild to significant left ventricular systolic dysfunction. Patients with a relatively focal nature of the disease and free from left main coronary artery or confluence of front left descendent artery could be considered for PCI (primary coronary intervention). When stents become widely available, patients would probably request PCI first instead of CABG. It is very important to remember that irrespective of PCI or CABG being preferred in diabetic patients, the role of drug therapy is enormous. Due to the diabetic patient susceptibility to fast progression of the disease and plaque rupture, drug therapy is indispensable in this population, e.g., aspirin, clopidogrel, 3-hydroxy-3-methylglytaryl-coenzyme A (HMGCoA) inhibitor reductase and ACE-inhibitor.

American Ginseng Extract (Panax quinquefolius L.) Is Safe in Long-Term Use in Type 2 Diabetic Patients.

Aim. The objective of the present study was to test the safety of supplementation with the American ginseng (AG) interventional material as an adjunct to conventional therapy (diet and/or medications) in type 2 diabetes, using a double-blind, randomized, placebo-controlled, parallel design. Methods. Each participant received either AG (10% ginsenosides) or placebo capsules (500 mg/meal = 3 g/day) for a period of 12 weeks. Outcomes included measures of safety including kidney function (urates and creatinine), liver function (AST and ALT), and haemostatic function (PV and INR). Results. Seventy-four participants with well-controlled type 2 diabetes (sex: 28 M and 46 F, age: 63 ± 9.5, BMI: 32 ± 5, and HbA1c: 7 ± 1.3), randomized to either intervention (n = 35) or control (n = 39) group, completed the study. There was no change in any of the measures of safety between treatments from baseline. The number or severity of adverse events did not differ between the AG intervention and placebo. Conclusion. Following 12 weeks of supplementation with AG, safety was not compromised in a high cardiovascular disease (CVD) risk population of patients with type 2 diabetes. This demonstrated that safety is noteworthy, as reviews have continuously warned of possible adverse effects of ginseng consumption.

Effect of American ginseng (Panax quinquefolius L.) on arterial stiffness in subjects with type-2 diabetes and concomitant hypertension.

ETHNOPHARMACOLOGICAL RELEVANCE: Substantial pre-clinical and some clinical data are available showing that Asian ginseng (Panax ginseng C.A. Meyer) varieties or its particular ginsenosides exert a vasodilatating effect, thus may modulate vascular function. However, the clinical evidence for American ginseng (Panax quinquefolius L.) is scarce. Therefore, this study evaluates the effect of American ginseng (AG) on arterial stiffness, as measured by augmentation index (AI), and blood pressure (BP), in type 2 diabetes patients with concomitant hypertension. MATERIALS AND METHODS: Using a double-blind, placebo-controlled, parallel design, each participant was randomized to either the selected AG extract or placebo at daily dose of 3g for 12 weeks as an adjunct to their usual antihypertensive and anti-diabetic therapy (diet and/or medications). AI and BP were measured by applanation tonometry at baseline and after 12 weeks of treatment. RESULTS: A total of 64 individuals with well-controlled essential hypertension and type 2 diabetes (gender: 22 M:42 F, age:63 ± 9.3 years, BP: 145 ± 10.8/84 ± 8.0 mmHg, HbA1c: 7.0 ± 1.3%, fasting blood glucose (FBG): 8.1 ± 2.3 mmol/L) completed the study. Compared to placebo, 3g of AG significantly lowered radial AI by 5.3% (P=0.041) and systolic BP by 11.7% (P<0.001) at 12 weeks. No effect was observed with diastolic BP. CONCLUSIONS: Addition of AG extract to conventional therapy in diabetes with concomitant hypertension improved arterial stiffness and attenuated systolic BP, thus warrants further investigation on long-term endothelial parameters before recommended as an adjunct treatment.

The effect of pharmacotherapeutic counseling on readmissions and emergency department visits.

OBJECTIVE: To evaluate the impact of pharmacotherapeutic counseling on the rates and causes of 30-day post-discharge hospital readmissions and emergency department visits. SETTING: The study was conducted at the Medical Clinic of University Hospital Dubrava, Zagreb, Croatia. METHODS: The study included elderly patients prescribed with two or more medications for the treatment of chronic diseases. The patients randomized into the intervention group received pre-discharge counseling by the clinical pharmacologist about each prescribed medication. The control group received no counseling. MAIN OUTCOME MEASURES: The rates and causes of 30-day postdischarge hospital readmissions and emergency department visits. Medication compliance was also evaluated, using the pill count method. RESULTS: A total of 160 patients were randomly selected for the study. No significant difference was found in the readmission and emergency department visit rates between the intervention and control groups (p = 0.224). There were 34.9 % more compliant patients in the intervention group. Significantly more non-compliant patients in the control group were readmitted or visited emergency department because of the disease progression (p = 0.031). In the intervention group, significantly more patients were readmitted or visited emergency department because of an adverse drug reaction (p = 0.022). CONCLUSION: Pharmacotherapeutic counseling can reduce readmission and emergency department visit rates for disease progression. Improved patient knowledge about adverse drug reactions could be the reason for increased rates of readmissions and emergency department visits due to adverse drug reactions in the intervention group.

Pituitary metastasis presenting as ischemic pituitary apoplexy following heparin-induced thrombocytopenia.

Pituitary apoplexy (PA) typically results from infarction or hemorrhage in a pituitary adenoma, while PA in nonadenomatous pituitary gland is uncommon. Prothrombotic states have never been recognized as precipitating factors for PA. The authors report a case of an elderly female who received prophylactic fractionated heparin therapy due to sepsis, consequent rhabdomyolysis, and overt disseminated intravascular coagulation. On the seventh day of heparin therapy, she reported sudden vision loss, ptosis, diplopia, and severe headache. Severe thrombocytopenia and positive antibodies to the complex of platelet factor 4 and heparin confirmed heparin-induced thrombocytopenia type 2 (HIT). Magnetic resonance imaging disclosed a homogenous pituitary tumor mass with pronounced sphenoid sinus mucosa thickening and two hypointense zones within the tumor mass on contrast-enhanced images consistent with focal ischemic necrosis. The tumor was confirmed to be squamous cell carcinoma with no signs of necrosis. Ischemic necrosis was found within marginal pituitary tissue. This is the first reported case of ischemic PA associated with pituitary metastasis and the first case in which HIT triggered PA. Our case demonstrates that prothrombotic states such as HIT can precipitate ischemic PA. Pituitary metastasis can present with ischemic PA, but radiological features differ from those described in pituitary adenomas. Segregated low-signal intensity zones within the tumor mass on postcontrast images indicate partial infarction of the tumor, which could be a special feature of ischemic PA in pituitary metastasis and has never been described in pituitary adenomas. These are all novel findings and might enlighten the pathogenesis of PA.

Effects of prandial versus fasting glycemia on cardiovascular outcomes in type 2 diabetes: the HEART2D trial.

OBJECTIVE: Hyperglycemia and Its Effect After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus (HEART2D) is a multinational, randomized, controlled trial designed to compare the effects of prandial versus fasting glycemic control on risk for cardiovascular outcomes in patients with type 2 diabetes after acute myocardial infarction (AMI). RESEARCH DESIGN AND METHODS: Patients (type 2 diabetes, aged 30-75 years) were randomly assigned within 21 days after AMI to the 1) prandial strategy (PRANDIAL) (three premeal doses of insulin lispro targeting 2-h postprandial blood glucose <7.5 mmol/l) or the 2) basal strategy (BASAL) (NPH twice daily or insulin glargine once daily targeting fasting/premeal blood glucose <6.7 mmol/l). RESULTS: A total of 1,115 patients were randomly assigned (PRANDIAL n = 557; BASAL n = 558), and the mean patient participation after randomization was 963 days (range 1-1,687 days). The trial was stopped for lack of efficacy. Risks of first combined adjudicated primary cardiovascular events in the PRANDIAL (n = 174, 31.2%) and BASAL (n = 181, 32.4%) groups were similar (hazard ratio 0.98 [95% CI 0.8-1.21]). Mean A1C did not differ between the PRANDIAL and BASAL groups (7.7 +/- 0.1 vs. 7.8 +/- 0.1%; P = 0.4) during the study. The PRANDIAL group showed a lower daily mean postprandial blood glucose (7.8 vs. 8.6 mmol/l; P < 0.01) and 2-h postprandial blood glucose excursion (0.1 vs. 1.3 mmol/l; P < 0.001) versus the BASAL group. The BASAL group showed lower mean fasting blood glucose (7.0 vs. 8.1 mmol/l; P < 0.001) and similar daily fasting/premeal blood glucose (7.7 vs. 7.3 mmol/l; P = 0.233) versus the PRANDIAL group. CONCLUSIONS: Treating diabetic survivors of AMI with prandial versus basal strategies achieved differences in fasting blood glucose, less-than-expected differences in postprandial blood glucose, similar levels of A1C, and no difference in risk for future cardiovascular event rates.