Effects of Cardiac Autonomic Dysfunction on Mortality Risk in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial

OBJECTIVE

Intensive therapy targeting normal blood glucose increased mortality compared with standard treatment in a randomized clinical trial of 10,251 participants with type 2 diabetes at high-risk for cardiovascular disease (CVD) events. We evaluated whether the presence of cardiac autonomic neuropathy (CAN) at baseline modified the effect of intensive compared with standard glycemia treatment on mortality outcomes in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial participants.

RESEARCH DESIGN AND METHODS

CAN was assessed by measures of heart rate variability (HRV) and QT index (QTI) computed from 10-s resting electrocardiograms in 8,135 ACCORD trial participants with valid measurements (mean age 63.0 years, 40% women). Prespecified CAN definitions included a composite of the lowest quartile of HRV and highest QTI quartile in the presence or absence of peripheral neuropathy. Outcomes were all-cause and CVD mortality. Associations between CAN and mortality were evaluated by proportional hazards analysis, adjusting for treatment group allocation, CVD history, and multiple prespecified baseline covariates.

RESULTS

During a mean 3.5 years follow-up, there were 329 deaths from all causes. In fully adjusted analyses, participants with baseline CAN were 1.55–2.14 times as likely to die as participants without CAN, depending on the CAN definition used (P < 0.02 for all). The effect of allocation to the intensive group on all-cause and CVD mortality was similar in participants with or without CAN at baseline (P_interaction > 0.7).

CONCLUSIONS

Whereas CAN was associated with increased mortality in this high-risk type 2 diabetes cohort, these analyses indicate that participants with CAN at baseline had similar mortality outcomes from intensive compared with standard glycemia treatment in the ACCORD cohort.It has been generally accepted that intensive glycemic control is paramount for preventing development and progression of chronic diabetes complications (1,2). The recently reported increased mortality associated with intensive control of hyperglycemia in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial (3) has led to controversy about implementation of intensive glucose control in patients with type 2 diabetes.There was a consistent effect on mortality from the intensive compared with standard treatment in the prespecified subgroup analyses (3). To date no adequate explanation for these findings of increased mortality with intensive glycemic control has been identified.Cardiac autonomic neuropathy (CAN), which can be documented by abnormal heart rate variability (HRV), occurs commonly in patients with diabetes and is associated with silent myocardial ischemia (4) and increased mortality (5). In addition, peripheral neuropathy is a prevalent complication of diabetes, and emerging evidence links excess mortality in diabetes with the presence of diabetic peripheral neuropathy (DPN) (6,7).It is also possible that individuals with baseline CAN may be more susceptible to mortality associated with hypoglycemia when glycemia therapy is intensified because of impaired hormonal and autonomic responses to subsequent hypoglycemia (8,9). To further investigate possible contributors to the higher mortality risk in the intensive glycemia arm of the ACCORD trial, we examined whether the presence of CAN at baseline with or without DPN may have contributed to this outcome.     

Weight Loss,Glycemic Control,and Cardiovascular Disease Risk Factors in Response to Differential Diet Composition in a Weight Loss Program in Type 2 Diabetes: A Randomized Controlled Trial

OBJECTIVE

To test whether a weight loss program promotes greater weight loss, glycemic control, and improved cardiovascular disease risk factors compared with control conditions and whether there is a differential response to higher versus lower carbohydrate intake.

RESEARCH DESIGN AND METHODS

This randomized controlled trial at two university medical centers enrolled 227 overweight or obese adults with type 2 diabetes and assigned them to parallel in-person diet and exercise counseling, with prepackaged foods in a planned menu during the initial phase, or to usual care (UC; two weight loss counseling sessions and monthly contacts).

RESULTS

Relative weight loss was 7.4% (95% CI 5.7–9.2%), 9.0% (7.1–10.9%), and 2.5% (1.3–3.8%) for the lower fat, lower carbohydrate, and UC groups (P < 0.001 intervention effect). Glycemic control markers and triglyceride levels were lower in the intervention groups compared with UC group at 1 year (fasting glucose 141 [95% CI 133–149] vs. 159 [144–174] mg/dL, P = 0.023; hemoglobin A_1c 6.9% [6.6–7.1%] vs. 7.5% [7.1–7.9%] or 52 [49–54] vs. 58 [54–63] mmol/mol, P = 0.001; triglycerides 148 [134–163] vs. 204 [173–234] mg/dL, P < 0.001). The lower versus higher carbohydrate groups maintained lower hemoglobin A_1c (6.6% [95% CI 6.3–6.8%] vs. 7.2% [6.8–7.5%] or 49 [45–51] vs. 55 [51–58] mmol/mol) at 1 year (P = 0.008).

CONCLUSIONS

The weight loss program resulted in greater weight loss and improved glycemic control in type 2 diabetes.     

Relationship Between Baseline Glycemic Control and Cognitive Function in Individuals With Type 2 Diabetes and Other Cardiovascular Risk Factors: The Action to Control Cardiovascular Risk in Diabetes-Memory in Diabetes (ACCORD-MIND) trial

OBJECTIVE—Diabetes is associated with cognitive decline and dementia. However, the relationship between the degree of hyperglycemia and cognitive status remains unclear. This was explored using baseline cognitive measures collected in the ongoing Memory in Diabetes (MIND) substudy of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.RESEARCH DESIGN AND METHODS—The relationship of A1C and fasting plasma glucose (FPG) levels to performance on four cognitive tests was assessed, adjusting for age and other determinants of cognitive status. The tests were the Digit Symbol Substitution Test (DSST), Mini Mental Status Examination (MMSE), Rey Auditory Verbal Learning Test, and Stroop Test.RESULTS—A statistically significant age-adjusted association was observed between the A1C level and the score on all four cognitive tests. Specifically, a 1% higher A1C value was associated with a significant 1.75-point lower DSST score (95% CI −1.22 to −2.28; P < 0.0001), a 0.20-point lower MMSE score (−0.11 to −0.28; P < 0.0001), a 0.11-point lower memory score (−0.02 to −0.19, P = 0.0142), and a worse score (i.e., 0.75 s more) on the Stroop Test (1.31–0.19, P = 0.0094). The association between the DSST score and A1C persisted in all multiple linear regression models. FPG was not associated with test performance.CONCLUSIONS—Higher A1C levels are associated with lower cognitive function in individuals with diabetes. The effect of glucose lowering on cognitive function will be determined by the ongoing ACCORD-MIND trial.Mild cognitive impairment represents an important phase on the path from normal cognitive function to dementia. Affected individuals have measurable deficits in cognitive function that may affect their ability to master complex behaviors such as those required for diabetes self-care (1). Moreover, because mild cognitive impairment is more common than frank dementia, its potential population health impact is high. For example, the prevalence of mild cognitive impairment (i.e., predementia) in the Cardiovascular Health Study was 19% in individuals aged >65 years and 29% in those aged >85 years.Diabetes is associated with premature mortality and is a risk factor for mild cognitive impairment and both vascular dementia (2–5) and Alzheimer''s disease (2,6–8). Indeed, individuals with diabetes are ∼1.5 times more likely to experience cognitive decline and frank dementia than individuals without diabetes (9). Precise reasons for the high morbidity and mortality of diabetes remain unknown; however, many studies have demonstrated a link between many of the consequences of diabetes and the degree of hyperglycemia as measured by the A1C or glucose level. Emerging evidence suggests that a relationship between measures of short-term glucose control and cognitive function also exists. For example, in a cross-sectional analysis of 378 high-functioning individuals with diabetes, higher A1C but not fasting plasma glucose (FPG) levels were consistently associated with lower scores on two cognitive tests (10). Smaller studies reported a similar relationship with indexes of dysglycemia (11,12); nevertheless, details regarding such a relationship remain unclear.The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is a randomized controlled trial of 10,251 individuals with established type 2 diabetes who have a high risk for cardiovascular disease (CVD) and whose screening A1C was ≥7.5%. It will determine whether therapeutic strategies targeting normoglycemia, normotension, and/or a normal lipid profile can reduce the rate of cardiovascular events more than standard therapeutic approaches in individuals with type 2 diabetes and either previous cardiovascular events or additional cardiovascular risk factors. The Memory in Diabetes (MIND) substudy of the ACCORD trial will determine whether these interventions reduce cognitive decline and structural brain changes in a subset of 2,977 randomized individuals from sites that participated in the MIND substudy. Baseline data from the MIND substudy provide a unique opportunity to assess the cross-sectional relationship between cognitive function and two different measures of glycemia: A1C and FPG.     

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial and Hurricane Katrina: lessons for managing clinical trials during and after a natural disaster

Hurricane Katrina was one of the most catastrophic natural disasters to hit the United States. It had a major impact on health care in New Orleans, LA and the surrounding region, not only in relation to acute illness but also chronic disease. When Hurricane Katrina struck New Orleans on August 29, 2005, there were 193 participants being followed in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial at Tulane University Health Sciences Center. In the immediate aftermath of the storm, the Tulane University ACCORD Study site, in collaboration with the Study Coordinating Center and the Southeast Clinical Center Network office of the trial at Wake Forest University Health Sciences in North Carolina, took several actions in order to locate the participants, ensure their safety, and maintain the scientific integrity of the trial. We describe the actions taken and the relative success/failure of such actions.     

The Cross-sectional and Longitudinal Associations of Diabetic Retinopathy With Cognitive Function and Brain MRI Findings: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial

OBJECTIVELongitudinal evidence linking diabetic retinopathy with changes in brain structure and cognition is sparse. We used data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial to determine whether diabetic retinopathy at baseline predicted changes in brain structure or cognition 40 months later.RESULTSBaseline retinopathy was associated with lower gray matter volume (adjusted means of 470, 466, and 461 cm³ for none, mild, and moderate/severe retinopathy, respectively; P = 0.03). Baseline retinopathy also predicted a greater change in MMSE and DSST scores at 40 months in each retinopathy category (MMSE: −0.20, −0.57, and −0.42, respectively [P = 0.04]; DSST: −1.30, −1.84, and −2.89, respectively[P = 0.01]).CONCLUSIONSDiabetic retinopathy is associated with future cognitive decline in people with type 2 diabetes. Although diabetic retinopathy is not a perfect proxy for diabetes-related brain and cognitive decline, patients with type 2 diabetes and retinopathy represent a subgroup at higher risk for future cognitive decline.     

Intensive blood pressure treatment does not improve cardiovascular outcomes in centrally obese hypertensive individuals with diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial

OBJECTIVE

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial reported no differences in most cardiovascular disease (CVD) outcomes between intensive and standard blood pressure therapy in individuals with diabetes mellitus (DM) and hypertension. Many such individuals are centrally obese. Here we evaluate whether the trial outcomes varied by the level of central obesity.

RESEARCH DESIGN AND METHODS

The cohort included 4,687 people (47.7% women) with DM and hypertension. Mean age was 62.2, and mean follow-up was 4.7 years. Participants were randomly assigned to one of two blood pressure treatment strategies: intensive (systolic <120 mmHg) or standard (systolic <140 mmHg). Sex-specific quartiles of waist-to-height ratio were used as the measure of central obesity. The primary ACCORD outcome (a composite of nonfatal myocardial infarction [MI], nonfatal stroke, or CVD death) and three secondary outcomes (nonfatal MI, fatal or nonfatal stroke, and CVD death) were examined using proportional hazard models.

RESULTS

There was no evidence that the effect of intensively lowering blood pressure differed by quartile of waist-to-height ratio for any of the four outcomes (P > 0.25 in all cases). Controlling for waist-to-height quartile had no significant impact on previously published results for intensive blood pressure therapy. Waist-to-height ratio was significantly related to CVD mortality (hazard ratio 2.32 [95% CI 1.40–3.83], P = 0.0009 comparing the heaviest to lightest quartiles), but not to the other outcomes (P > 0.09 in all cases).

CONCLUSIONS

Intensive lowering of blood pressure versus standard treatment does not ameliorate CVD risk in individuals with DM and hypertension. These results did not vary by quartile of waist-to-height ratio.Central obesity is strongly and linearly related to the development of hypertension (1). The mechanisms for this association lie in the relationship of visceral fat with cardiometabolic disturbances, such as insulin resistance, increased sympathetic tone, inflammatory protein production, intravascular volume expansion, and activation of the renin-angiotensin system (2). Many of these factors also lead to the development of diabetes mellitus (DM).In general, greater relative cardiovascular disease (CVD) risk reduction is obtained from risk factor modification in individuals who are “sickest.” For example, individuals with DM, compared with those without DM, have greater risk reduction of myocardial infarction (MI) and stroke from blood pressure reduction (3). It is therefore intuitive to hypothesize (although not necessarily true) that aggressive modification of hypertension in centrally obese individuals with DM could lead to greater CVD event reduction relative to those with DM who are not centrally obese. This hypothesis has not been tested.The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial tested the hypothesis that intensive lowering of systolic blood pressure (<120 mmHg) in individuals with type 2 DM and hypertension would result in fewer adverse CVD outcomes than conventional treatment (<140 mmHg). The study reported that intensive lowering of blood pressure did not reduce the primary composite outcome of cardiovascular death, nonfatal MI, or nonfatal stroke or secondary outcomes, with the exception of stroke (4). In this study, we examine whether central obesity modifies the risk of CVD outcomes in those randomized to intensive versus standard blood pressure treatment. We hypothesize that intensive blood pressure modification results in greater CVD risk reduction in those with higher versus lower degrees central obesity.     

Intensive Risk Factor Management and Cardiovascular Autonomic Neuropathy in Type 2 Diabetes: The ACCORD Trial

OBJECTIVEThe effects of preventive interventions on cardiovascular autonomic neuropathy (CAN) remain unclear. We examined the effect of intensively treating traditional risk factors for CAN, including hyperglycemia, hypertension, and dyslipidemia, in individuals with type 2 diabetes (T2D) and high cardiovascular risk participating in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.RESEARCH DESIGN AND METHODSCAN was defined as heart rate variability indices below the fifth percentile of the normal distribution. Of 10,251 ACCORD participants, 71% (n = 7,275) had a CAN evaluation at study entry and at least once after randomization. The effects of intensive interventions on CAN were analyzed among these subjects through generalized linear mixed models.RESULTSAs compared with standard intervention, intensive glucose treatment reduced CAN risk by 16% (odds ratio [OR] 0.84, 95% CI 0.75–0.94, P = 0.003)—an effect driven by individuals without cardiovascular disease (CVD) at baseline (OR 0.73, 95% CI 0.63–0.85, P < 0.0001) rather than those with CVD (OR 1.10, 95% CI 0.91–1.34, P = 0.34) (P_interaction = 0.001). Intensive blood pressure (BP) intervention decreased CAN risk by 25% (OR 0.75, 95% CI 0.63–0.89, P = 0.001), especially in patients ≥65 years old (OR 0.66, 95% CI 0.49–0.88, P = 0.005) (P_interaction = 0.05). Fenofibrate did not have a significant effect on CAN (OR 0.91, 95% CI 0.78–1.07, P = 0.26).CONCLUSIONSThese data confirm a beneficial effect of intensive glycemic therapy and demonstrate, for the first time, a similar benefit of intensive BP control on CAN in T2D. A negative CVD history identifies T2D patients who especially benefit from intensive glycemic control for CAN prevention.     

Metabolomic Prediction of Diabetes and Cardiovascular Risk

No abstract available.     

西咪替丁对抗精神病药物所引起体重增加的影响对照研究

目的验证西咪替丁对AP源性BWG的疗效、安全性和对血脂的影响。方法采用前瞻性平行对照研究方法，90例患者分为西咪替丁治疗组和对照组，治疗8周。定期测体重、腰围、血脂，评定PANSS、TESS、住院患者生活满意度量表。结果（1）治疗组体重减轻（6周P〈0．05，8周P〈0．01）；（2）两组治疗前后TG的差值有差异（P〈0．05），血脂变化与体重变化无相关（P〉0．05）；（3）治疗组生活满意度多项因子分高于对照组（P〈0．05）；（4）两组副反应无差异（P〉0．05）。治疗组PANSS总分下降（P〈0．05）。结论西咪替丁能减轻AP源性BWG，安全性好，可影响血脂水平。     

Update on Cardiovascular Outcomes at 30 Years of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study

OBJECTIVE

To describe the beneficial long-term effects of an average of 6.5 years of intensive diabetes therapy (INT) in type 1 diabetes on measures of atherosclerosis, cardiac structure and function, and clinical cardiovascular events observed in the Diabetes Control and Complications Trial (DCCT) and the Epidemiology of Diabetes Interventions and Complications (EDIC) study.

RESEARCH DESIGN AND METHODS

The DCCT was a randomized clinical trial of 1,441 participants assigned to receive INT or conventional therapy (CON). It was conducted between 1983–1993 with an average follow-up of 6.5 years. EDIC (1994–present) is an observational follow-up of the DCCT cohort. Cardiovascular events have been recorded throughout. During EDIC common carotid intima-media thickness (IMT) was measured with ultrasound, coronary artery calcification with computed tomography, and cardiac structure and function with cardiac magnetic resonance imaging.

RESULTS

DCCT INT and lower levels of HbA_1c during DCCT/EDIC were associated with thinner carotid IMT, less coronary calcification, and a lower incidence of clinical cardiovascular events including myocardial infarction, stroke, and cardiac death. While there were no significant differences in cardiac structure and function between the former INT and CON groups, they were significantly associated with higher HbA_1c during DCCT/EDIC.

CONCLUSIONS

DCCT INT and the attendant 6.5 years of lower HbA_1c had long-term salutary effects on the development and progression of atherosclerosis and cardiovascular disease during the subsequent follow-up during EDIC.     

Effect of Intensive Compared With Standard Glycemia Treatment Strategies on Mortality by Baseline Subgroup Characteristics: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial

OBJECTIVE

To determine if baseline subgroups in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial can be identified for whom intensive compared with standard glycemia treatment had different effects on all-cause mortality.

RESEARCH DESIGN AND METHODS

Exploratory post hoc intention-to-treat comparisons were made between intensive and standard glycemia groups on all-cause mortality by subgroups defined by baseline characteristics.

RESULTS

There were few significant interactions between baseline characteristics and effects of intensive versus standard glycemia treatment on mortality: self-reported history of neuropathy (hazard ratio [HR] 1.95, 95% CI 1.41–2.69) versus no history of neuropathy (0.99, 0.79–1.26; P value for interaction 0.0008), higher A1C (A1C >8.5%: HR 1.64, 95% CI 1.22–2.22; A1C 7.5–8.4%: 1.00, 0.75–1.34; A1C <7.5%: 1.00, 0.67–1.50; P value for interaction 0.04), and aspirin use (HR 1.45, 95% CI 1.13–1.85, compared with 0.96, 0.72–1.27, in nonusers; P value for interaction 0.03).

CONCLUSIONS

We found a remarkable similarity of effect from intensive compared with standard glycemia treatment on mortality across most baseline subgroups. No differential effect was found in subgroups defined by variables anticipated to have an interaction: age, duration of diabetes, and previous history of cardiovascular disease. The three baseline characteristics that defined subgroups for which there was a differential effect on mortality may help identify patients with type 2 diabetes at higher risk of mortality from intensive regimens for glycemic control. Further research is warranted.Numerous epidemiological studies have demonstrated a relationship between elevated A1C and a greater risk of cardiovascular (CVD) events and mortality in type 2 diabetes (1–3). Therefore, it has been hypothesized that a reduction to near-normal levels of A1C in patients with type 2 diabetes would reduce the risk of these adverse outcomes. Three large randomized controlled clinical trials testing this hypothesis in individuals with longstanding type 2 diabetes reported their main results in the past 2 years (4–6).The Data Safety Monitoring Board of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial discontinued the intensive glycemia arm because of an increase in all-cause mortality in the intensive glycemia arm compared with the standard glycemia arm. The finding of excess mortality in the intensive arm of the ACCORD trial has led to controversy about implementation of intensive glucose control in patients with type 2 diabetes (7,8). Adding to the controversy were results of the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) and Veterans Affairs Diabetes Trial (VADT), demonstrating that although there was no significant reduction in the primary end point of CVD events, there was no increase in mortality with the intensive glycemia arm compared with the standard glycemia arm (4,6), which has raised questions about reasons for these discrepancies (9–12).A critical question relates to the applicability and generalizability of the conclusions of the ACCORD trial to the broader population or to specific subgroups of patients with type 2 diabetes. Indeed, prespecified subgroup analyses in ACCORD did suggest a significant benefit of intensive glycemic control on CVD events in those participants with lower A1C at entry or absence of CVD event by history, but there was no suggestion of a differential effect on mortality (5). However, these observations are based on only a few subgroup analyses at the time of the primary publication. The effect on mortality of intensive compared with standard glycemia treatment may have been modified by other possible characteristics of patients at entry. We have therefore carried out exploratory post hoc analyses of the effects of intensive compared with standard glycemia treatment in ACCORD participants categorized by various baseline characteristics on all-cause mortality at the time of discontinuation of the intensive glycemia treatment of ACCORD, with the goal to determine if particular subgroups at higher or lower risk from the intensive intervention can be identified.     

Cardiovascular Risk Attributable to Diabetes in Southern Brazil: A population-based cohort study

OBJECTIVE

To analyze the effect of diabetes on general and cardiovascular disease (CVD) mortality and morbidity in southern Brazil.

RESEARCH DESIGN AND METHODS

A population-based cohort study of 1,091 individuals was conducted. Diabetes was ascertained by medical history. The vital status of 982 individuals and the incidence of events were ascertained during another visit and through hospital records, death certificates, and verbal necropsy with relatives.

RESULTS

The mean ± SD age of participants was 43.1 ± 17 years, and 55.7% were women. The prevalence of diabetes was 4.2%, and the mean follow-up time was 5.3 ± 0.07 years. Mortality was 36.3% and 6.6% in participants with or without diabetes, respectively; the incidence of CVD was 20.8% and 3.0%, with an adjusted hazard ratio of 4.4 (95% CI 2.4–7.9). Diabetic population-attributable risk (PAR) for CVD mortality was 10.1% and 13.1% for total CVD.

CONCLUSIONS

Diabetes is responsible for a large PAR for overall mortality and cardiovascular events in Brazil.Approximately 2.2 million deaths worldwide from ischemic heart disease and stroke were attributed to high levels of blood glucose in 2001 (1). We describe the effect of diabetes on cardiovascular disease (CVD) morbidity and mortality in southern Brazil.     

Effects of Cardiovascular Disease Risk Communication for Patients With Type 2 Diabetes on Risk Perception in a Randomized Controlled Trial: The @RISK Study

OBJECTIVE

Patients with type 2 diabetes mellitus (T2DM) underestimate their risk of developing severe complications, and they do not always understand the risk communication by their caregivers. The aim of this study was to investigate the effects of an intervention focused on the communication of the absolute 10-year risk of developing cardiovascular disease (CVD) in patients with T2DM.

RESEARCH DESIGN AND METHODS

A randomized controlled trial was performed in T2DM patients newly referred to the Diabetes Care System (DCS) West-Friesland, a managed-care system in the Netherlands. The intervention group (n = 131) received a six-step CVD risk communication. Control subjects (n = 130) received standard managed care. The primary outcome measure was appropriateness of risk perception (difference between actual CVD risk calculated by the UK Prospective Diabetes Study risk engine and risk perception). Secondary outcome measures were illness perceptions, attitude and intention to change behavior, satisfaction with the communication, and anxiety and worry about CVD risk. Patients completed questionnaires at baseline, at 2 weeks (immediately after the intervention), and at 12 weeks.

RESULTS

Appropriateness of risk perception improved between the intervention and control groups at 2 weeks. This effect disappeared at 12 weeks. No effects were found on illness perceptions, attitude and intention to change behavior, or anxiety and worry about CVD risk. Patients in the intervention group were significantly more satisfied with the communication.

CONCLUSIONS

This risk communication method improved patients’ risk perception at 2 weeks but not at 12 weeks. Negative effects were not found, as patients did not become anxious or worried after the CVD risk communication.Care for patients with type 2 diabetes mellitus (T2DM) is focused on optimal control of the disease and the prevention of the development of severe complications, in particular cardiovascular disease (CVD) (1). Increasing evidence suggests that patients who take a more active role in their care achieve better health outcomes (2), and appropriate risk communication may facilitate this process (3). Although studies have shown that general risk communication is helpful for patients with T2DM, studies incorporating patients’ individual risk are scarce, and, in particular, the effects on the intention to perform self-management activities are unclear (4–7).In the current study, a cardiovascular risk communication intervention was developed for T2DM patients incorporating the individual risk for CVD. Three principles that have been shown to be important in risk communication were used in the development of this intervention. The first principle was to provide a simple and clear message on the causes and consequences of the risk of developing CVD and on what actions can possibly prevent CVD (3,8). The second was to use a simple format, such as visual presentations of the risk rather than percentages, which patients might be able to better understand, although evidence is mixed (5,9–14). Third, communication of the benefits of change in a so-called positive frame, rather than a negative presentation—for example, in terms of loss of healthy years—has been shown to increase patients’ motivation (4,13,15). The rationale for this study was based on Leventhal’s self-regulation theory and the Theory of Planned Behavior (TPB). According to the self-regulation theory, patients have perceptions concerning their disease that are either correct or incorrect (16,17). These perceptions determine how patients cope with their disease and manage their risks of developing complications (18). It is hypothesized that providing understandable risk information may change the illness perceptions, which in turn may change the attitude concerning importance of behavior change and intention to change—as laid down in the TPB (19).The aim of the current study was to investigate the effects of a CVD risk communication intervention on appropriateness of risk perception in patients with T2DM. Secondary objectives were to investigate the effects on illness perceptions, attitude, and intention to change behavior. In addition, patients’ general satisfaction with the communication and anxiety and worry about CVD risk were assessed to check for adverse effects of risk communication.