[ Diabetes Type 1 ]

Trials

N2 – Coronary heart disease (CHD) is highly prevalent in patients with diabetes mellitus (DM), and remains the single most common cause of death among this population. In particular, we report here for the first time that FMD is independently associated with SMI; and even more specifically when ischemia is associated with CAD on angiography. Results Patients with longer duration of diabetes possessed higher rates of obstructive CAD (P < 0.001). Published for the Infectious Diseases Society of America. Significant stenosis was defined as coronary artery stenosis > 70%. 36.7 ± 8.1 years [P < 0.001] and 8.5 ± 1.1 vs. Mean LVEF at rest and after exercise in the normal group was 66 +/- 7% and 76 +/- 9%, respectively. The coronary disease distribution was described based on the affected vessel: LCA, LAD artery, circumflex artery (CX), and right coronary (RCA) artery. The prevalence and severity of asymptomatic CAD are comparably high in men and women with T2DM. Prevalence was highest in the age group between 75 and 85 years and already 600,000 individuals between 30 and 70 years were known to have diabetes [3]. MRI is more sensitive than X-ray to detect traumatic skeletal lesions [23]. The organisms are not sensitive to the commonly available antibacterial agents. This is a high volume procedure laboratory serving as the hub in our district. All eligible patients will be asked to participate. A recent US report demonstrated that the mortality rates among both American men and women with diabetes decreased substantially between 1997 and 2006, reducing the absolute difference between adults with and without diabetes [24]. At the first visit they will be given a brochure containing detailed information about diabetes, hypertension, atherosclerosis and prevention. All participants will continue with regular follow ups scheduled by the referral diabetes outpatients service. Personal and clinical data regarding diabetes, cardiovascular risk factors, medications and blood pressure measurements will be collected. Information on laboratory parameters including lipid profile, serum creatinine, HbA1c will also be collected. Cardiovascular risk will be calculated according to the Italian risk chart provided by Istituto Superiore di Sanità [14]. During follow up the occurrence of any clinical event included in the end-points will be notified and verified through the registers of local Hospital admissions.

After the completion of follow each patient will be contacted for the final visit. We chose a stratified block randomization with one to one allocation ratio. Diabetes was diagnosed according to American Diabetes Association criteria (17). Pharmacological/behavioural prevention of cardiovascular events will be the same in both groups. Experimental and control group will continue to be followed at our local Diabetic Clinics that will try to provide maximal adherence the European Society of Cardiology Guideline [18] indications about control of hypertension, hypercholesterolemia and glycaemia. A maximal symptom-limited exercise protocol will be used with a treadmill (T-2100 Treadmill – GE Healthcare medical system) according to the standard Bruce protocol. Patients underwent 2D transthoracic echocardiography at baseline and at 2-year follow-up using a commercially available system (Vivid 7 and E9, General-Electric Vingmed, Horton, Norway) equipped with 3.5-MHz and M5S transducers.

Twelve ECG leads will be recorded every minute and blood pressure will be measured manually at rest and every three minutes. Ventilatory oxygen consumption, expressed in multiples of resting requirements (METS), will be estimated by exercise duration. The exercise test will be defined as maximal if the patient will reach 80% of the predicted exercise capacity according to Gulati formula [19]. Sub maximal tests without ECG signs and/or symptoms of ischemia will be considered not diagnostic and will not lead to any other procedure. The exercise test will be considered positive if showing horizontal or downsloping ST segment depression of 1 mm or more calculated at 0.06-0.08 second after the J point at precordial leads (V3-V6). Coronary artery disease will be defined as being significant if lumen stenosis will be greater than 50% at level of left main or left anterior descending, or greater than 70% at level of circumflex or right coronary artery. Based on existing data we can assume that about 80% patients will test negative [20] and run a risk of 0.97% per year [21] while the remaining 20% of patients will test positive running a risk of 1.03% per year after treatment according to the results of the ACIP trial [22].

This results in a mean risk of 1.03 per year within the group. The cardiac event rate reported in over 10000 Italian diabetic patients without evidence of cardiac disease was collected by the Italian Istituto Superiore di Sanità (Diabetes and Informatics Study Group): the cumulative incidence of cardiac events was 2.88% per year in men and 2.33% per year in women [23]. The incidence rates will be estimated using Kaplan-Meier survival curves that will be compared using logrank analysis. The treatment efficacy will be assessed by multivariate analyses using Cox’s regression model. During the study interim analyses will be performed every year with the scope of verifying the correctness of the assumptions made for sample size estimation with regard to the primary end point event rate (this information can influence the duration of follow up) and to avoid unforecast excess of event rate in the treatment group. We will assess the incremental costs and the economic consequences of screening for asymptomatic coronary artery disease in diabetic patients with the aim of revascularization compared with usual care alone according to established methods for the analysis of patient-level data [25]. The association of diabetes mellitus and urinary tract infections is increasingly being reported.

The study will be conducted in accordance with European Commission guidelines for Good Clinical Practice and performed according to the revised Declaration of Helsinki. The study protocol was approved by local Ethical Committee. The trial was registered at ClinicalTrial: the U.S. National Institute of Health registry of federally and privately supported clinical trials conducted in the United States and around the world [NCT00547872]. The study results will be submitted for publication in an appropriate journal irrespective of the outcome. Trial data will be reported according to the Consolidated Standards of Reporting Trials (CONSORT statements) [26]. The principal investigator will be responsible for timely generation of report manuscripts, and prior to submission the co-investigators will review and approve study results.

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[ Diabetes Type 2 ]

Trials

In randomized trials and many observational studies, statins are associated with a modest excess of type 2 diabetes mellitus. RESULTS After adjustment for baseline CAC and other confounders, progression of CAC was significantly higher in more frequent statin users than in less frequent users (mean ± SE, 8.2 ± 0.5 mm3 vs. The workgroups are open to all members of PQA and use a consensus-based approach to identify, prioritize and recommend the measure concepts that are deemed to be highly important for supporting quality improvement related to medications. Although this association was not significant in subgroup analysis for the non-diabetics, this could possibly be due to the small number of patients with HbA1c results in this subgroup. An increase in statin dose was allowed only if a patient’s cholesterol levels were not controlled adequately according to Japanese guidelines, but decisions about adjusting diabetes medication were left to the treating physicians’ discretion. Patients categorized as having no known diabetes either had a normal OGTT or prediabetes. The authors found that, if they included all six studies in the analysis (a total of 2,082 cases of incident diabetes in 57,593 study participants), there was no significant association between statin use and the development of type 2 diabetes (relative risk 1.06 [95% CI 0.93–1.25]).

In September 2014, a study published in the journal The Lancet found that the enzyme that statin drugs are designed to act upon to control cholesterol is also linked to a number of factors affecting blood sugar. Al Powers, director of the diabetes division of endocrinology and metabolism at Vanderbilt University Medical Center. Pravastatin showed least benefit due to its lipophilicity and inability to cross the blood-brain barrier when compared to atorvastatin and simvastatin. This risk is likely outweighed by the benefits of reducing cardiovascular risk. Topol. “The risks of CVD in the trials may be higher than in those treated with statins in the population, but this paper unnecessarily raises a scare about diabetes and statins, using relative percentage increases that make for headlines. Nevertheless, no specific information is available for patients with diabetes mellitus, for whom there is the suspicion that aspirin could be less effective [8], making additional research urgently needed.

I’m talking about endogenous (body-produced) cholesterol, okay, so this is not your excuse to eat bacon. On the other hand, there is a substantial lack of reliable information about the benefits of primary prevention strategies aimed at reducing the overall risk associated with diabetes. For all these reasons, the evaluation of cardiovascular preventive strategies in patients with diabetes represents a priority in terms of public health. All of these statins are now available as generic drugs, and high dosage levels have been most often linked with the increase in diabetes. In addition to his lab work, Adams is also the (non-paid) executive director of the non-profit Consumer Wellness Center (CWC), an organization that redirects 100% of its donations receipts to grant programs that teach children and women how to grow their own food or vastly improve their nutrition. More recently, an analysis on more than 1000 patients with diabetes enrolled in the Primary Prevention Project (PPP) confirmed a non statistically significant reduction of 10% in the incidence of major CV events in individuals treated with aspirin as compared with controls [10]. Brown and Goldstein discovered that the underlying mechanism to hereditary familial hypercholesterolemia is a partial or complete lack of functional LDL receptors leading to decreased clearance of cholesterol from the circulation and higher levels of blood cholesterol.

This study showed that aspirin had no significant effect on the risk of myocardial infarction or cardiovascular death neither in women without diabetes, nor in those with diabetes. Previous studies have found that in this class of women, statins do not drive down the risk of dying of heart disease or other causes. On the other hand, diabetes could represent a special case of aspirin resistance [8], although no specific studies have, to our knowledge, fully explored this hypothesis. The reason for the apparently reduced aspirin efficacy in diabetic patients remains largely unclear, however both, intraplatelet mechanisms and extra-platelet inflammatory-thrombogenic factors may contribute to the complexity of aspirin failure in diabetic patients. In high risk patients treated with aspirin, inadequate suppression of Cox-1 as documented by high levels of serum thromboxane-2 [12] or urinary thromboxane metabolites [13], may be associated with increased risk of recurrent cardiovascular events. Moreover, in some cases the antiplatelet effects of aspirin can be overwhelmed by aspirin-insensitive mechanisms of platelet activation and thrombus formation, mainly related to an up-regulated vascular inflammatory reaction [8, 14]. If you have been offered a statin to reduce your cholesterol, you will only reduce your CVD risk if it is taken alongside good exercise, regular exercise and controlled blood pressure, while avoiding smoking and excessive alcohol.

Diabetes is also associated with a reduction in the production of, and sensitivity to nitric oxide and PGI2, two of the most important antiaggregants. Furthermore, an increased platelet sensitivity to aggregant agents has also been described [18]. It has been recently shown that platelet response to aspirin is linearly reduced with increasing cholesterol plasma levels. The presence of dyslipidemia, particularly common among diabetic patients, could thus be at least partially responsible for a lower efficacy of aspirin in this population [19]. R. One additional reason to hypothesize a positive effect of statins in improving platelet response to aspirin is related to their anti-inflammatory properties. Several studies have shown that treatment with statins is associated with a decrease in the levels of C-reactive protein in just a few weeks [20, 21].

People with pre-diabetes should only be treated with statins if they have a markedly elevated risk of heart attack and stroke. Clinical and experimental studies have shown that statins can reduce endothelial dysfunction by increasing the production of nitric oxide (NO), decreasing the synthesis of endothelin-1 and inhibiting the LDL cholesterol oxidation [23]. This class of drugs has also been shown to increase atherosclerotic plaque stability by reducing macrophage cholesterol accumulation and production of metalloproteases [23]. Therefore, if an upregulated vascular inflammatory reaction is responsible for aspirin resistance, it is plausible to hypothesize that statins would also improve the clinical response to aspirin therapy. On the other hand, if platelets of diabetic patients were normally inhibited by aspirin, but other thrombogenic stimuli not inhibited by aspirin overwhelm aspirin action, statins could exert a complementary action by inhibiting these mechanisms; in fact, statins may exert antithrombotic effects by interfering with platelet adhesion and aggregation, expression of tissue factor and plasminogen activator inhibitor-1 (PAI-1), fibrinogen concentration and blood viscosity [22]. Given these premises, it is of crucial importance to conduct a large-scale, pragmatic trial to evaluate the effectiveness of aspirin use in primary prevention of cardiovascular events in association with statins therapy when included in a strategy of global risk control. The choice of simvastatin is based on economical considerations; in fact, Simvastatin is the only statin available in Italy as an equivalent product, thus implying substantially lower costs in comparison with brand products.

This result was adjusted to account for demographic variables, health habits, medication use, a family history of diabetes, and body mass index/waist circumference.

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[ Diabetes Type 2 ]

Trials

Diabetic retinopathy (DR) is a common clinical expression of diabetes mellitus-induced vasculopathy and is a major cause of vision loss. A 30-year-old woman with poorly controlled type 2 diabetes mellitus visited our clinic in 2004. In 2009, NHS Scotland rolled out a new automated grading system which helped to analyse retinal eye images for a specific eye pathology associated with retinopathy. Here’s an example of a case study where an optometrist was able to save a patient’s vision and one showing how an optometrist helped a child to settle in school  to show how your finished case study will look. This study of Middle European Caucasians included patients with angiographically documented CAD (n = 487), subjects with type 2 diabetes mellitus with (n = 149) or without (n = 78) diabetic retinopathy and control subjects without clinical manifestations of atherosclerotic disease (n = 1527). We noted hard exudates (HE) in the posterior pole, but away from foveal tissue. The resulting data was evaluated block by block, using the analysis of variance (ANOVA) and a conditional logistic regression analysis.

management). These data suggest that TZDs do not cause subclinical DME in a demographically diverse patient population with diabetes. System-level factors included miscommunication about where the patient lives, their clinical situation and practical problems that could have been overcome had their existence been shared between programmes. No APD Extraocular Movements: Full OU. Focal treatment was also applied to microaneurysms or other lesions thought to be causing macular edema. This work is published and licensed by Dove Medical Press Limited. Additionally, although oleic acid is the main component of olive oil, many other substances in this fat source, especially anti-oxidants and anti-inflammatory polyphenols, could play a neuroprotective role in the retina [20–22].


Proliferative retinopathy-This indicates severe ischaemia of the retina leading to new vessel formation in the optic disc or in the periphery of the retina or iris. Personal Ocular History: Patient undergoes his first laser photocoagulation treatment on his right eye 8 months ago, and a second laser treatment 4 months ago. He is also placed on an ACE-I and a statin to achieve a blood pressure less than 130/85 mm Hg and an LDL less than 70 mg/dL. Indeed, it is a dominant concern for many trialists. For example, the Diabetic Retinopathy Awareness Program study [4] undertook many initiatives to recruit volunteers and concluded, “these experiences substantiate the need for a comprehensive coordinated approach, using planned sources, to achieve recruitment success” (pp432). As a result, the service has amended the data collection process for primary care providers. It can be argued that marketing is especially important in clinical trials.

Participation in a trial is a formal voluntary act, in that participants need to abide by a set of rules. Accordingly, not only is it necessary for people to volunteer, they also need to sign-up to behave in accordance with a set procedure [7]. In short, participants in a trial (be they clinicians or patients or their families) need to make a commitment, and undertake additional work, often without direct financial benefit to themselves. From a marketing perspective, conducting a successful trial can be seen as a process with five main stages (Figure 1 ). One explanation could be the different geographical distribution of mtDNA haplogroups. HPFH is common in populations that have high frequencies of other hemoglobinopathies and thalassemias, particularly in patients of Mediterranean, African, and Asian origin. 3.

To construct a marketing function within the trial and devise robust systems for ensuring that the marketing (and later sales) activities are undertaken efficiently, effectively and in accordance with the values and goals of the trial. The technology is COM components based and written in Microsoft Visual C++ and Microsoft VisualBasic. To convey, fully and persuasively, the ‘value proposition’ to intermediaries (e.g. doctors or nurses), influencing bodies (e.g. ethics committees) and other agents that can either help or hinder the conduct of the trial. In this case, we coordinated with the patient’s primary care physician to enroll him in Spanish-speaking diabetic education classes near the patient’s home. Undoubtedly they undertake the activities listed in the table 1 in some way.

Nevertheless, our study methodology is comparable to other epidemiological investigations done under similar conditions, such as that by Zhang et al. Moss, T.Y.

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[ Herbal Remedies ]

Trials

Background: Depression is a common comorbidity among patients with type 2 diabetes. Alloxan monohydrate in a dose of 75 mg/kg body weight effectively produced permanent diabetes. Depressive disorders and severity were diagnosed by the Structured Clinical Interview for DSM-IV Axis Ι disorders, clinical version, and the spouse and family scales of the Illness Invalidation Inventory, respectively (3*I). Most parents I know don’t want to be narcissistic and complain of their own sacrifices and challenges. Close examination of results revealed that, in fact, diabetic and nondiabetic adolescent girls were very similar. OBJECTIVE: To compare the prevalence and patterns of depressive symptoms among women with type 2 diabetes in Puebla, Mexico, and Chicago, United States. There was no evidence of cognitive impairment or depression in either group.

Firstly there is the reality of living with this all encompassing illness for every minute of every day for the rest of your life. In addition they should make sure that patients are aware of the signs of depression and alert their physician so that they can get proper help. The prevalence of MDE was 71.43%. Food and Drug Administration approval for use as a treatment for type 2 diabetes. Investigating in detail the relation of diabetic neuropathy and depression, it derives that a high degree of diabetic neuropathy is related with high score of depression [F(3.160)=9.821, p=0.001]. The severity of neuropathic pain was evaluated using the Douleur Neuropathique-4 (DN4) questionnaire and a visual analogue scale (VAS). The instrument uses a 4-point response scale ranging from “rarely or none of the time” to “most or all of the time” with total scores ranging from 0 to 60.

• Psychotherapy Depression isn’t only rooted in physical causes, though. These specialized clinics differ from general diabetic care clinics in that in these specialized clinics foremost patients with severe diabetes with complications are present and specialized clinical diabetes care is provided by a team of a diabetologist, a specialized diabetes nurse and a dietician. The Problem Areas in Diabetes (PAID) questionnaire is a 20-item, self-report scale that asks respondents to rate how much of a problem they find each of the 20 diabetes-related issues. Principally this study has a presumption that the burden of mental health especially depression is high in the population with type 2 diabetes mellitus co-morbidity and requires attention to diagnose early and treat promptly. The PAID scores are summed (with total scores ranging from 0 to 80) and transformed to a 0–100 scale with higher scores indicating more diabetes-related distress. Medication may be helpful if counseling alone isn’t effective enough. The short-form health survey (SF-12 v2) comprises self-assessments of general health, physical functioning, physical roles, bodily pain, vitality, social functioning, emotional roles and mental health.

The raw scores for particular subscales are transformed to a 0–100 scale with higher scores indicating better health-related quality of life. The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report questionnaire of diabetes self-management that includes items assessing general diet, specific diet, exercise, blood glucose testing, foot care and smoking. The questionnaire asks the respondents about the frequency with which they performed self-care activities over the previous 7 days. Higher subscale scores indicate more regular performing of the self-care activities included. Medical data were collected from the patients’ medical records. HbA1c was determined by an automated immunoturbidimetric method using Bayer reagents (Tarrytown, Il, USA) on Olympus AU600 analyser (Olympus Optical Co., Tokyo, Japan) with a normal range from 3.5 to 5.7% [26]. The first two meetings were held within a week of each other, and the third and the fourth at two-week intervals.

Patients were provided with a self-help manual for overcoming depressive difficulties based on the “Coping with depression” course by P.M. Lewinsohn [27, 28]. The manual was given to the participating patients prior to the first session in order to make them familiar with the course contents and to facilitate reflecting their own experiences. The manual’s structure aimed to stimulate introducing personal examples and making notes. The group sessions consisted of discussing particular topics rather than listening about them. A part of the manual was a workbook containing exercises to recognize depressive symptoms, become aware of daily activity patterns, plan more pleasurable activities, solve problems by using a four-step approach, and to recognize and modify cognitive patterns that contribute to maintenance of depression. The exercises were planned as homework.

It included keeping mood and daily activities diary, planning daily activities to include more enjoyable ones, practicing a problem solving technique to manage personal problems the patients were faced with, and using the acquired knowledge to improve self-awareness, primarily with respect to automatic negative thoughts that worsen the depressive mood. The patients’ experiences in going through the homework were discussed at the beginning of the subsequent session. The manual was tested for comprehensibility and clarity in a group of diabetic patients (N = 8) with different demographic and disease-related characteristics. For the purpose of this study, the programme was partially modified and adjusted to diabetes-specific emotional problems. The patients screened for depression demonstrating elevated result were given explanation of their result and were informed about available treatment options. Serum glucose was determined using a glucose oxidase assay kit (Sigma, St. Sample size calculation was based on the absolute change in depressive symptoms as measured by the CES-D questionnaire from the run-in period to the 6- and 12-month follow-up assessments.

To demonstrate a clinically meaningful difference in the CES-D scores with alpha = 0.05 and power of 90%, and assuming a common standard deviation of the CES-D scores of 8.4, 94 patients would be needed in each group. These preliminary results were analysed using non-parametric statistics including medians and modes to describe measures of central tendencies and variability, Mann-Whitney U test to determine between-group differences at the three measurement points, and the Friedman ANOVA test to determine within-group differences in depression-related and metabolic outcomes.

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