Abstract:
BACKGROUND:Patients with type 2 diabetes (T2DM) are at increased risk for macrovascular events as well as for microvascular complications. There is evidence that in patients with coronary artery disease (CAD), about 35 % suffer from manifest T2DM. Early glucose-lowering intervention in subjects with T2DM has been demonstrated to be beneficial in terms of cardiovascular risk reduction. But thus far, no data are available regarding investigating the impact of linagliptin treatment in patients with early diabetes on cardiovascular endpoints or surrogate parameters. Therefore, the aim of this study is to investigate the effects of linagliptin in CAD patients with early T2DM on various cardiovascular surrogate measurements including mechanical and biochemical endothelial function assessments. METHODS/DESIGN:Forty-two subjects with early diabetes and CAD are included in this investigator-driven, randomized, placebo-controlled, double-blind, phase IV, single-center study. Participants will be randomized to receive either linagliptin (5 mg) administered once daily per os or placebo for 12 weeks. Before and after the intervention, evaluation of endothelial function (flow-mediated dilatation and biochemical biomarkers) and a Meal Tolerance Test are performed. DISCUSSION:Cardiovascular surrogate parameters, such as endothelial function, are able to provide insights into the potential mechanisms of the cardiovascular effects of antihyperglycemic agents. Currently ongoing trials do not specifically focus on early diabetes as a target of intervention and we therefore believe that our study will contribute to a better understanding of the cardiovascular effects of dipeptidylpeptidase-4 (DPP-4) inhibitors in early diabetes. TRIAL REGISTRATION:NCT02350478 . Registered 26 January 2015. Protocol date/version 24 October 2014/version 2.4 EudraCT number: 2013-000330-35.
journal_name
Trialsjournal_title
Trialsauthors
Tripolt NJ,Aberer F,Riedl R,Hutz B,Url J,Dimsity G,Meinitzer A,Stojakovic T,Hödl R,Brodmann M,Hafner F,Sourij Hdoi
10.1186/s13063-016-1627-3subject
Has Abstractpub_date
2016-10-13 00:00:00pages
495issue
1issn
1745-6215pii
10.1186/s13063-016-1627-3journal_volume
17pub_type
杂志文章,随机对照试验相关文献
Trials文献大全abstract:BACKGROUND:There is a strong evidence base for the benefits of parenting interventions for parents without severe mental illness (SMI). As the impact of maternal SMI can be significant on child development, mothers need support to maximise outcomes for themselves and their children. Some mothers with SMI require admiss...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2869-z
更新日期:2018-09-10 00:00:00
abstract:BACKGROUND:Depression and bipolar disorder are associated with reduced neural plasticity and deficits in memory, attention and executive function. Drug treatments for these affective disorders have insufficient clinical effects in a large group and fail to reverse cognitive deficits. There is thus a need for more effec...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-11-97
更新日期:2010-10-13 00:00:00
abstract:BACKGROUND:The burden of acute gastroenteritis on children and their families continues to be enormous. Probiotics, defined as viable microbial preparations that have a beneficial effect on the health of the host, represent a rapidly expanding field. Although clinical trials in children with gastroenteritis have been p...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-170
更新日期:2014-05-14 00:00:00
abstract:BACKGROUND:Coronary artery disease is the leading cause of morbidity and mortality in patients with type 2 diabetes. Screening for asymptomatic coronary artery disease with treatment by means of revascularization seems to be an appealing option for prevention. The utility of such a strategy has never been challenged in...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-10-119
更新日期:2009-12-23 00:00:00
abstract:BACKGROUND:Carotid atherosclerosis disease (CAD) is generally associated with the occurrence of cardiovascular and cerebrovascular accidents. However, CAD has not been taken seriously enough in the clinic, which, coupled with the single treatment and prevention of CAD, has led to a generally low level of patient compli...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04709-0
更新日期:2020-09-07 00:00:00
abstract:BACKGROUND:Cognitive behavioural therapy is an effective treatment for depression. However, one third of the patients do not respond satisfactorily, and relapse rates of around 30 % within the first post-treatment year were reported in a recent meta-analysis. In total, 30-50 % of remitted patients present with residual...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0875-y
更新日期:2015-08-11 00:00:00
abstract:BACKGROUND:In a sham-controlled double-blind trial, we aim to establish the efficacy and safety of the local application of laser therapy in patients with diabetes, onychomycosis and risk factors for diabetes-related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn lead to increas...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0622-4
更新日期:2015-03-22 00:00:00
abstract:BACKGROUND:There has been a recent steep growth in platelet-rich plasma (PRP) use for musculoskeletal conditions, but findings from high quality clinical trial data are lacking in the literature. Here, we describe the statistical analysis plan (SAP) for the Platelet-rich plasma in Achilles Tendon Healing 2 (PATH-2) tri...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2840-z
更新日期:2018-08-29 00:00:00
abstract:BACKGROUND:The ACTION study (Attention deficit hyperactivity disorder Controlled Trial Investigation Of a Non-stimulant) is a multi-center, double-blind, randomized cross-over trial of the non-stimulant medication, Atomoxetine, in children and adolescents with attention deficit hyperactivity disorder (ADHD). The primar...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-12-77
更新日期:2011-03-13 00:00:00
abstract:BACKGROUND:Acute kidney injury is a common and devastating complication of critical illness, for which renal replacement therapy is frequently needed to manage severe cases. While a recent systematic review suggested that "earlier" initiation of renal replacement therapy improves survival, completed trials are limited ...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-320
更新日期:2013-10-05 00:00:00
abstract:BACKGROUND:Surgery induces insulin resistance that might be alleviated by a nutritional drink given preoperatively. The authors hypothesized that some of the beneficial effects of the drink could be attributed to the volume component (approximately 1 L) rather than to the nutrients. METHODS:Sixty patients scheduled fo...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-13-97
更新日期:2012-07-02 00:00:00
abstract:BACKGROUND:Photobiomodulation using low-level laser therapy (LLLT) has been tested as a new technique to optimize recovery of patients with traumatic brain injury (TBI). The aim of this study is to evaluate inhibitory attentional control after 18 sessions of active LLLT and compare with the placebo group (sham LLLT). O...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-2414-5
更新日期:2018-01-08 00:00:00
abstract:BACKGROUND:Idiopathic sudden sensorineural hearing loss (ISSNHL) is a rapid-onset sensorineural hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction has been considered as a poor indicator in the clinical manifestations and prognosis of ISSNHL, which occurred in approximat...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04579-6
更新日期:2020-07-22 00:00:00
abstract:BACKGROUND:Depression occurs in up to 50% of patients after stroke and limits rehabilitation and recovery. Mood disorders are also highly prevalent in carers; their mental health intertwined with the physical and mental wellbeing of the person they are caring for. We argue that working with families, rather than patien...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-105
更新日期:2011-04-30 00:00:00
abstract:BACKGROUND:The serious mental illness Health Improvement Profile [HIP] is a brief pragmatic tool, which enables mental health nurses to work together with patients to screen physical health and take evidence-based action when variables are identified to be at risk. Piloting has demonstrated clinical utility and accepta...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-167
更新日期:2011-07-04 00:00:00
abstract:BACKGROUND:Generalized anxiety disorder (GAD) is a psychiatric disorder characterized by a constant and unspecific anxiety that interferes with daily-life activities. Its high prevalence in general population and the severe limitations it causes, point out the necessity to find new efficient strategies to treat it. Tog...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-9-25
更新日期:2008-05-05 00:00:00
abstract:BACKGROUND:HIV-related stigma significantly impacts HIV care engagement, including in prevention of mother-to-child transmission of HIV (PMTCT) programs. Maisha is a stigma-based counseling intervention delivered during the first antenatal care (ANC) visit, complementing routine HIV counseling and testing. The goal of ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-019-3933-z
更新日期:2019-12-30 00:00:00
abstract:BACKGROUND:Anxiety in children is common and incapacitating and increases the risk of mental health disorders in adulthood. Although effective interventions are available, few children are identified and referred for specialist treatment. Alternative approaches in which prevention programmes are delivered in school app...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-77
更新日期:2014-03-13 00:00:00
abstract:BACKGROUND:Incurable cancer does not only affect patients, it also affects the lives of their partners. Many partners take on caregiving responsibilities. The burden of these caregiving tasks are often associated with physical, psychological, and social difficulties and many partners have unmet supportive care needs. O...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-4037-5
更新日期:2020-01-31 00:00:00
abstract:BACKGROUND:Attrition is problematic in trials, and may be exacerbated in longer studies, telehealth trials and participants with depression - three features of The Healthlines Study. Advance notification, including a photograph and using action-oriented email subject lines might increase response rates, but require fur...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1234-3
更新日期:2016-02-24 00:00:00
abstract::Adaptations to the gold standard randomised controlled trial (RCT) have been introduced to decrease trial costs and avoid high sample sizes. To facilitate development of precision medicine algorithms that aim to optimise treatment allocation for individual patients, we propose a new RCT adaptation termed the nested-pr...
journal_title:Trials
pub_type: 信件
doi:10.1186/s13063-020-04965-0
更新日期:2021-01-06 00:00:00
abstract:BACKGROUND:Burns and the associated wound care procedures can be extremely painful and anxiety-provoking for children. Burn injured children and adolescents are therefore at greater risk of experiencing a range of psychological reactions, in particular posttraumatic stress disorder, which can persist for months to year...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1346-9
更新日期:2016-04-29 00:00:00
abstract:BACKGROUND:Acute respiratory failure (ARF) remains the leading reason for intensive care unit (ICU) admission of immunocompromised patients. In the most severe cases, high-flow oxygen therapy may fail to ensure adequate gas exchange, and mechanical ventilation (MV) must be used. This scenario is associated with high mo...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-372
更新日期:2014-09-25 00:00:00
abstract:BACKGROUND:Depressive and anxiety disorders are common in general practice but not always treated adequately. Introducing stepped care might improve this. In this randomized trial we examined the effectiveness of such a stepped care model. METHODS:The study population consisted of primary care attendees aged 18-65 yea...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-171
更新日期:2011-07-07 00:00:00
abstract:BACKGROUND:Among clinical trials of interventions that aim to modify time spent on mechanical ventilation for critically ill patients there is considerable inconsistency in chosen outcomes and how they are measured. The Core Outcomes in Ventilation Trials (COVenT) study aims to develop a set of core outcomes for use in...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0905-9
更新日期:2015-08-20 00:00:00
abstract:BACKGROUND:Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and m...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-8-2
更新日期:2007-01-18 00:00:00
abstract:BACKGROUND:The cross-sectional area of the subclavian vein (csSCV) is an important factor determining the success rate of SCV catheterization. The head-down position increases the csSCV. However, the effects of lateral tilting on subclavian venous cross-sectional area have not yet been explored. In this trial, we test ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2666-8
更新日期:2018-05-24 00:00:00
abstract:BACKGROUND:For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet drugs results in an increase in the...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2542-6
更新日期:2018-03-05 00:00:00
abstract:BACKGROUND:Despite a burgeoning interest in using interprofessional approaches to promote effective collaboration in health care, systematic reviews find scant evidence of benefit. This protocol describes the first cluster randomized controlled trial (RCT) to design and evaluate an intervention intended to improve inte...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-8-23
更新日期:2007-09-18 00:00:00
abstract:BACKGROUND:Depression accounts for the greatest burden of disease among all mental health problems, and is expected to become the second-highest amongst all general health problems by 2020. By the age of 75, 1 in 7 older people meet formal diagnostic criteria for depression. Efforts to ameliorate the burden of illness ...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-12-225
更新日期:2011-10-11 00:00:00