Active clinical trials for "Diabetes Mellitus, Type 2"

Thirty years ago, Dzau and Braunwald introduced the concept of a continuum of cardiovascular diseases and defined them as a series of events caused by numerous related and unrelated risk factors, thus developing to end-stage heart disease through many pathophysiological pathways and processes. Owing to treatment concept changes and the urgency of investigating T2D combined with CHF, SUs are being re-evaluated, of which glimepiride is undoubtedly the most promising.

The purpose of this study is to determine whether night time eating that coincides with elevated endogenous melatonin impairs glucose tolerance, particularly in carriers of the MTNR1B risk allele.

The purpose of this study is to evaluate the effects of Empagliflozin on cardiac structure, function and circulating biomarkers in patients with Type II diabetes. Empagliflozin (anti-hyperglycemic agent), approved by Health Canada and the FDA for the treatment of Type II diabetes, demonstrated a reduction in cardiovascular deaths and heart failure from a previous post-marketing clinical trial. The use of empagliflozin to treat patients with diabetes and heart disease has been approved by Health Canada. However, the process by which it may give this beneficial effect remains unclear and needs further investigation. Therefore, the aim of this study is to provide a fundamental understanding of the mechanistic basis by which Empagliflozin could provide its potential cardio-protective effects by employing the use of Cardiac Magnetic Resonance Imaging (CMRI).

The purpose of this study was to investigate the influence of micro- and macrovascular changes on the cardiac function in relation to left ventricular function and coronary arteries during one year in patients with type 2 diabetes.

Recent reports show increased prevalence of obesity in patients with type 1 diabetes (T1DP)s while some studies stated that patients with type 2 diabetes (T2DPs) have islet cell auto-antibodies. These results raise the question of a common pathway in T1DM and T2DM via an association with T helper cells. In this study investigators aimed to investigate the difference between T helper 1 (Th1) cytokines levels in T1DPs, T2DPs and healthy subjects. The study included 114 T1DPs on insulin treatment, 35 newly diagnosed T2DPs who had not used oral antidiabetics but insulin before and 31 healthy subjects (CG). Serum interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α) levels were measured using ELISA method. Serum levels of those cytokines in T1DPs were compared with those in T2DPs and controls.

Investigators propose to use a natural experiment design to examine the impacts of the new CPT code (99490) for chronic care management on health outcomes. The Investigators will collaborate with partners in the Louisiana Clinical Data Research Network (LaCDRN) who serve more than 90,000 patients with type 2 diabetes mellitus in Louisiana to examine impacts of the CMS reimbursed care coordination. Now, LaCDRN is renamed as Research Action for Health Network (REACHnet). Patient and stakeholder engagement will be planned and implemented across all phases of this natural experiment. This project will examine outcome differences created by the policy change in a natural experiment framework. The analyses will utilize the RE-AIM framework to identify the critical elements of the programs that will enhance the reach, effectiveness, adoption, implementation, and maintenance of these strategies in the diverse LaCDRN diabetes populations. PCORI Proposal COVID-19- Related Enhancement for Existing Research: The proposed enhancement will contribute timely information to address two important implications of the coronavirus pandemic: Disparities in continuity of care and Health systems' responsiveness in terms of telehealth delivery for high risk populations. The enhancement builds upon our current project by further examining effects of CMS payment innovations to expand remotely delivered care. Our proposed study is a rapid assessment of telehealth services, using an existing "learning health system" infrastructure to provide timely, actionable evidence to inform telehealth service provision during the pandemic and recovery.

CVD-REAL is a multinational, observational cohort study in patients with type 2 diabetes mellitus evaluating the comparative effectiveness of initiating treatment with a sodium-glucose co-transporter-2 (SGLT-2) inhibitor versus another glucose-lowering drug. This study will compare the risk of all-cause mortality and clinically relevant cardiovascular (CV) outcomes respectively in patients who are new users of SGLT-2 inhibitors with those who are new users of other glucose-lowering drugs. CVD-REAL is aiming to collect data from approximately 4 million patients overall, from twelve countries across three major world regions.

Cross-sectional study to investigate subjects at different stages of type 2 diabetes development with expected stratification of pancreatic islet mass. Non-diabetic individuals were assigned as control. The primary outcome was the [11C]5-hydroxy-tryptophan uptake and retention in the pancreas as a surrogate marker for the endogenous islet mass.

Through the multinational pooled dataset approach, this trial will aim to derive and validate specific in vivo Corneal Confocal Microscopy (CCM) parameter thresholds for the identification of diabetic polyneuropathy, and - more importantly - the identification of individuals at future risk. Results of the study will permit application in clinical practice and intervention trials for diabetic polyneuropathy (DPN) risk stratification. The primary goal of the study is to re-examine individuals with type 1 and type 2 diabetes with and without neuropathy, who had CCM performed in the past as a part of their neurological examination, to assess concurrent and predictive validity of different CCM parameters in individuals . These subjects will be invited to the study to be re-examined by CCM along with other neurological tests (physical exam, nerve conduction studies, quantitative sensory testing, blood test and in some centres also skin biopsy) during the single study visit. Additionally CCM data will be analyzed both manually and by recently developed automated analytical software to evaluate accuracy of the automated method. Evaluation of automated image analysis will influence likelihood of successful knowledge translation of this surrogate biomarker for DPN into clinical practice - in which the procedure could be harmonized with annual retinal examinations - and into intervention trials. Secondary aim of the study is to determine the factors associated with CCM parameters and their longitudinal change and collect bio-samples for future research in this field.

Diabetic foot ulcers constitute an increasing health problem in Denmark concurrent with an ageing population and an increase in diabetes prevalence. Diabetic foot ulcers belong to the most serious and costly complications. Several studies have found that the size and depth of the ulcer is one of the major etiologic factors for delayed healing. Wound measurement is important in the monitoring of the wound healing process. For the last decade different 3D (three-dimensional) techniques for measuring wounds have been proposed in order to measure wound volume, but none of the technologies have been widely used. A 3D Wound Assessment Monitor (WAM) camera has been developed, which is able to measure wound size in 3D and to assess wound characteristics. The investigators hypothesize that three-dimensional measurements of diabetic foot ulcers are feasible in the assessment of wound healing. A prospective cohort study is conducted in which newly admitted patients with a diabetic foot ulcer are included at the first visit at the multidisciplinary clinic. The patients are followed for one year or until complete wound healing, amputation or death. The four wound measurements: 2D area, 3D area, perimeter and volume are measured using the 3D-WAM camera with frequent intervals. Patient anthropometrics and wound data are collected during the study and correlated to the wound healing.