View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:Diabetic peripheral neuropathy is the most common complication to diabetes mellitus affecting as much as 50% of the population with diabetes. Symmetrical sensory neuropathy is by far the most common pattern, which often progress slowly over many years, although some individuals experience faster and more severe courses. Despite the frequent occurrence, the causes of diabetic peripheral neuropathy are largely unknown, which is reflected in the fact that no disease-modifying treatments are available for preventing, treating or even halting the progression of the disease. The consequences can be dire, as neuropathy frequently leads to foot ulcers, amputations or intolerable neuropathic pain in the lower extremities. Sensory loss may go completely undetected in diabetes, as there often are literally no symptoms. For many individuals, the development of diabetic peripheral neuropathy can therefore proceed completely unnoticed, making regular screening the most important tool for diagnosing the condition. Unfortunately, unlike nephropathy or retinopathy, diabetic peripheral neuropathy is not easily screened for, as the condition lacks reliable markers for early- or progressing disease. Therefore, screening for diabetic peripheral neuropathy currently revolves around diagnosing loss of protective sensation, judged by the inability to feel vibration or light touch. However, in their most recent guidelines, the American Diabetes Association has included screening for small fibre neuropathy using either the cold- and heat perception thresholds or pinprick as a clinical standard. Although this acknowledgement of the importance of assessing not only large- but also small nerve fibres is a huge step towards early detection of diabetic peripheral neuropathy, the overriding issue of insensitive, unreproducible, and inaccurate bedside tests for small nerve fibres remains. While cold- and heat perception and pinprick sensation are indeed mediated by small nerve fibres, the sensitivity of these methods, outside of extreme standardization only achievable in dedicated neuropathy research-centres, remain poor and not usable on an individual level. This lack of sensitivity has also become apparent in several large clinical trials, where the methods have continuously failed as robust clinical endpoints. Due to this, the hunt for a sensitive and reproducible method for adequate assessment of the small nerve fibres have begun. Amongst several interesting methods, two have gained particular interest (corneal confocal microscopy and skin biopsies with quantification of intra-epidermal nerve fiber density), due to their diverse strengths, although clinical application is currently limited to a few specialized sites. Furthermore, both methods suffer several inherent issues including that fact that they only provide information about the structure of the nerves and not the function. One method to assess the function of small cutaneous C-fibers is the assessment of the axon reflex flare response using laser doppler imaging (LDI) or Full-field laser perfusion imaging (FLPI), which has classically been studied using local heating. Unfortunately, this method is limited in clinical usage due to time-consumption. The investigators recently published an alternative method using a simple skin-prick application of histamine to evoke the response, which reduced the examination-time markedly. Before claiming the method to be a better alternative, the investigators do however need to prove that the method is as good as the original. In addition to the direct comparison of the histamine-induced and the heating-induced axon-reflex flare response the study will also assess spatial acuity in the same cohort as a secondary aim. Spatial acuity is considered as a measure of the sensory systems ability to code spatial information regarding an external stimulus. To investigate the spatial acuity, the 2-point discrimination task (2PDT) is often used. Spatial acuity has been shown to be impaired in several chronic pain condition. Additionally, it has been shown that the 2PDT may be a useful tool to understand the sensory changes in diabetes[8].
This study aims to investigate the myocardial phenotype of patients with type 2 diabetes. From 2016-2019 the investigators recruited a cohort of 296 subjects with type 2 diabetes. All subjects underwent clinical examinations including a gadolinium contrast cardiac MRI. The current study is a clinical follow-up study of the subjects, thus, the investigators will invite all participants to a reevaluation with cardiac MRI. Additionally, the investigators will aim at recruiting additionally 400 patients with type 2 diabetes. The aim it to characterize the phenotype of diabetic cardiomyopathy. Uniquely using cardiac MRI we can measure myocardial microvascular function, myocardial localised and diffuse fibrosis in addition to the quantification of myocardial structure and systolic and diastolic function.
This study aims to design, develop, and evaluate a smart insole to predict the formation of diabetic foot ulcers (DFUs) in diabetic participants at risk of developing them. The study will be conducted in two phases, using mixed-method research and engaging both diabetic participants and NHS clinicians. In Phase 1, the user-centred design of the smart insole will be developed through focus groups and online questionnaires, and a preliminary safety evaluation of the insole will be conducted with healthy team members. In Phase 2, the insole will be tested, validated, and data will be collected through baseline visits, lab studies, and insole data collection with shape-changed (pressure off-loading) insoles. The study will be conducted by researchers from the University of Manchester and the University of Exeter. It will include 10 people with diabetes and 10 healthy controls in Phase 2.
Non-communicable diseases (NCDs) are rising in prevalence because of aging, unhealthy diet and sedentary lifestyle, and common NCDs are caries and periodontitis (here oral diseases) and cardiovascular disease (CVD). Association between oral diseases and CVD has been observed in epidemiological studies, and suggested mechanisms include transfer of oral pathogen bacteria and pro-inflammatory mediators to other organs triggering immune response and systemic inflammation. Circulating mediators may initiate a response in the liver with production of C-reactive protein, serum amyloid A and increased tryptophan degradation, that contribute to CV inflammation and atherosclerosis. We have demonstrated that higher serum levels of these markers are associated with presence of hypertension and obesity and with higher risk of CVD. However, CVD and oral diseases also share many of the same risk factors, including hypertension, obesity, diabetes and smoking. Since the association of oral disease with CV risk factors mostly has been demonstrated in cross-sectional studies, the direction has not been ascertained. These CVD risk factors lead to changes in the heart and arteries (preclinical CVD); more harmful in women than men. If these conditions can impact development of oral diseases is not been investigated in large studies. Socio-economic inequalities have been reported for oral diseases and are linked to low socio-economic status (SES). It is unknown whether CV health and SES in midlife may impact prevalence of oral diseases later in life. It is also unknown if the oral microbiome differ by periodontitis severity and can be associated with inflammatory biomarkers, CV risk factors and preclinical CVD. The project will be performed in adults approaching the retirement age in Vestland county. We will combine their data from the ongoing Hordaland Oral Health Survey with their data from three surveys in the longitudinal Hordaland Health Study performed in the period 1992-2020.
The aim of this trial is to test components of a digital health outreach intervention to promote uptake of postpartum screening and lifestyle programs for diabetes prevention among patients with gestational diabetes (GDM). The outreach intervention, designed to be interactive and delivered online, includes standard health information plus up to four theory-based components, targeting motivational and logistical barriers to engaging in diabetes preventive care during the postpartum period. The trial leverages the Multiphase Optimization Strategy (MOST) using a randomized factorial study design.
Reinforcement learning is an advanced analytic method that discovers each individual's pattern of responsiveness by observing their actions and then implements a personalized strategy to optimize individuals' behaviors using trial and error. The goal of the proposed research is to refine, adapt and perform efficacy testing of a novel reinforcement learning-based text messaging intervention to support medication adherence for patients with type 2 diabetes within a community health center setting. This study will be a parallel randomized pragmatic trial comparing medication adherence and clinical outcomes for adults in a community setting aged 18-84 with type 2 diabetes who are prescribed 1-3 daily oral medications for this disease. Participants will be randomized to one of two arms for the duration of the study period: (1) a reinforcement learning intervention arm with up to daily, tailored text messages based on time-varying treatment-response patterns; or (2) a control arm with up to daily, un-tailored text messages. Outcomes of interest will be medication adherence, as measured by electronic pill bottles, and HbA1c levels over 6 months.
The objective of this study is to test the feasibility of using behavioral economic interventions (gamification with social incentives) to increase physical activity after hospital discharge to reduce incident mobility disability among older adults.
The study team's central hypothesis is that the Parkland Diabetes Detection Program (PDDP) screening invitations targeted by race/ethnicity with culturally concordant messaging and tailored by glycemic risk (known PDM vs. unknown glycemic state) plus phone-based navigation of non-responders will be more effective at closing screening gaps than PDDP generic screening invitations and usual care, opportunistic screening alone.
The DPPOS AD/ADRD project will address the overarching question: What are the determinants and the nature of cognitive impairment among persons with pre-diabetes (PreD) and type 2 diabetes (T2D), who are a high-risk group for cognitive impairment and represent a large fraction of the United States (US) population? This U19 proposal addresses the National Alzheimer's Project Act goal to "prevent, halt, or reverse AD" in the high-risk group of persons with pre-diabetes and type 2 diabetes, who represent over half of the population aged 60 years and older in the US.
Hypertension and diabetes mellitus (DM) are highly prevalent in low and middle-income countries, and the proportion of patients with uncontrolled diseases is higher than in high income countries. Innovative strategies are required to surpass barriers of low sources, distance, and quality of healthcare. Our aim is to assess the uptake and effectiveness of the implementation of an integrated multidimensional strategy in the primary care setting, for the management of patients with hypertension and diabetes mellitus (DM) in Brazil. This is a scale up implementation study that has mixed-methods, and comprehends four steps: (1) needs assessment, including a standardized structured questionnaire and focus groups with healthcare practitioners; (2) baseline period, three months before the implementation of the intervention; (3) cluster randomized controlled trial (RCT) with a 12-month follow-up period; and (4) a qualitative study after the end of follow-up. The cluster RCT will randomize 35 centres to intervention (n= 18) or usual care (n= 17). Patients ≥18 years-old, with diagnosis of hypertension and/or DM, of five Brazilian cities in a resource-constrained area will be enrolled. The intervention consists of a multifaceted strategy, with a multidisciplinary approach, including telehealth tools (decision support systems, short message service, telediagnosis), continued education with an approach to issues related to the care of people with hypertension and diabetes in primary care, including pharmacological and non-pharmacological treatment and behavioural change. The project has actions focused on professionals and patients.