View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:The purpose of this study is to assess the effects of diabetes mellitus (DM) on anterior chamber cytokine production and postoperative macular edema in patients undergoing femtosecond laser-assisted cataract surgery (FLACS). Patients with DM routinely undergo FLACS, yet the majority of studies evaluating intraocular inflammation following femtosecond laser treatment have excluded this patient population. Importantly, DM alters the inflammatory status of the eye, which may influence the production of inflammatory mediators following femtosecond laser treatment and the development of postoperative macular edema. The results from this study will provide insight into the risks and benefits of FLACS in patients with DM.
The purpose of this study is to evaluate the effectiveness and safety of the RIGHTEST Continuous Monitoring (CGM) System in adult population with diabetes mellitus.
Phase I/II Randomized Clinical Trial to evaluate the safety, pharmacokinetic and efficacy of Anti-SARS-CoV-2 hyperimmune serum. The study will include patients at early stage of COVID-19 with increased risk for severe disease due to underlying medical conditions to determine the utility of an equine heterologous serum anti-SARS-CoV-2 to avoid progression to a severe COVID-19
Results of this project will enable investigators to get information and to compare maternal and pregnancy characteristics and perinatal outcomes of women with different types of Diabetes Mellitus and to identify the independent risk factors for adverse perinatal outcomes. Particularly, the impact of the advanced age, obesity, and type of diabetes on the course and outcome of pregnancy will be evaluated.
This study is a RCT aiming to use CBT-I as intervention, compared to usual care as control, to elucidate the effect of CBT-I on glycemic control, sleep quality, psychological outcomes, and cognitive function in Hong Kong Chinese older T2D comorbid with insomnia.
Goals: to compare the effects of two distinct rehabilitation protocols (conventional shoulder musculoskeletal rehabilitation combined with aerobic exercises versus solely conventional shoulder musculoskeletal rehabilitation) on shoulder pain, function, strength, kinematics and tendon thickness in patients with type 2 DM after 12 weeks of intervention and a subsequent follow up of 8 weeks. The secondary objective of this study will be to evaluate the association between AGEs accumulation and shoulder pain, function, strength, kinematics and tendon thickness in individuals with type 2 DM. Methodology: is a single-blinded randomized controlled trial, in which all subjects with a clinical diagnosis of type 2 DM (with at least 1 year of diagnosis), of both sexes, between 40 and 70 years, presenting shoulder pain (uni or bilateral) for at least 3 months with a pain intensity score from 3 points on a numerical rating scale for pain intensity, will be invited to participate. The main outcomes of this study will include the AGEs accumulation through skin autofluorescence measurement; shoulder pain through NRS scales; shoulder function through SPADI questionnaire and range of motion measurement; isometric shoulder muscles strength through manual muscle dynamometer measurement; shoulder kinematics through three dimensional inertial units measurements; supraspinatus tendon thickness through ultrasound measurement. All these outcomes will be measured before and after the rehabilitation protocols. Participants will be randomly assigned to one of the two rehabilitation groups: specific shoulder rehabilitation protocol group (SRG); or 2) specific protocol of shoulder rehabilitation plus aerobic exercise group (ARG). All individuals will be evaluated before starting the rehabilitation protocol (baseline) and at the end of rehabilitation (post 12 weeks) and 8 weeks after the end of the rehabilitation (follow up). For the statistical analysis, to verify the effectiveness of protocols over time, a variance analysis (ANOVA) of mixed model with Bonferroni adjustment will be performed for pairwise comparisons. Variables that do not meet the ANOVA assumptions will be analyzed by the Mann-Whitney and Wilcoxon tests with Bonferroni correction a priori. In order to assess the secondary objective of the study, correlation tests depending on data distribution will be performed (Pearson or Spearman correlation tests). A simple linear regression analysis will also be performed in order to analyze how much the AGEs accumulation can explain the alterations in the musculoskeletal and biomechanical variables. The significance level will be set at 5%.
To compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1C in inadequately controlled T2DM subjects on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents. To assess the safety of repeat administration of ORMD-0801 in inadequately controlled T2DM subjects on on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents.
Earlier protocol ID was NN1250-4630, protocol ID is changed to NN1535-7774. The purpose of this study is to collect blood glucose values and activity data in patients with type 2 diabetes for approximately 12 weeks using electronic devices in a full virtual clinical setting. Virtual clinical setting means that all data are collected by use of participants' personal smartphone and study-related apps. In other words, everything will be handled without any visits to a hospital or doctor. For collection of participants' blood glucose values participants will receive two different blood glucose monitors. One where participants cannot see the blood glucose values and one where participants can see the blood glucose values. Participants must wear them consecutively for 2 and 10 weeks, respectively. Further, participants will be asked to self-apply the monitors on their upper arm. For collection of participants' activity data participants will receive an activity tracker, which participants will wear on the wrist throughout the study. We will ask participants to keep an electronic diary of the timing of the meal- and medication intake through two shorter periods of the study. On a voluntary basis, participants can choose to donate a saliva sample for the purpose of genetic research in diabetes patients. The study does not include any study medication and participants will continue the current antidiabetic treatment as prescribed to participants by their own physician. If any questions about the treatment and/or health condition while participating in the trial, participants should consult your own physician If participants are in doubt about what the blood glucose values mean or whether participants should react to the blood glucose values, participants need to contact the research staff or their general practitioner.
Three SGLT2i were commercially available in Italy at the time the trial was designed: canagliflozin, dapagliflozin, and empagliflozin. Preliminary evidence suggests that the higher dose canagliflozin (300 mg/day) might exert a stronger glucose-lowering effect than dapagliflozin or empagliflozin. The clinical relevance of this putative difference is however unknown. On the other side, the use of canagliflozin, but not empagliflozin and dapagliflozin, has been associated with an increased risk of some adverse events, namely bone fractures and lower limb amputations. Currently, the available information on the efficacy and safety of SGLT2i in elderly (70+ years) patients with type 2 diabetes are is very scant. Thus, a compelling need now exists of comparing efficacy and safety of the commercially available SGLT2i in a population of frail patients at high risk of cardiovascular and renal diseases.
The aim of the study is to assess whether the implementation of faster insulin aspart in children with Type 1 diabetes treated with intensive insulin therapy with the use of an insulin pump and using Real Time Continuous Glucose Monitoring (RT-CGM) systems leads to prolonged time in range (TIR) compared to insulin aspart.