Active clinical trials for "Diabetes Mellitus, Type 2"

Metformin is the most widely prescribed oral treatment for diabetes, and the only one that showed a survival benefit. Yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney disease (CKD) patients. The aim of the study is to describe the use and side-effects of metformin in CKD patients in routine practice.

Metformin has been used in Sweden since 1957, and it is recommended as first line therapy for type 2-diabetes (T2D) in national and international guidelines. However, adverse effects involving diarrhea, constipation, bloating, and abdominal pain are common which leads to discontinuation of medication or not being able to reach therapeutic doses. Here the investigators will perform a prospective study to investigate whether i) participants with T2D who experience adverse events following metformin treatment have an altered microbiota at baseline compared to participants without adverse events and ii) if the microbiota is altered in participants during onset of adverse events. The investigators hypothesis is that adverse effects associated with metformin are caused by an altered gut microbiota, either at base line or following metformin treatment. The study design is a nested case-cohort study. The investigators will recruit 600 patients and expect 200 individuals to have side effects and 400 without during a 24-month study period. Fecal samples will be collected at baseline, 2 months, and 4 months or when gastrointestinal symptoms occur. All fecal samples will be sequenced by 16s rRNA (ribosomal ribonucleic acid) sequencing to obtain a baseline microbiota profile; a subpopulation consisting of homogenous groups of participants will be in depth-analyzed using shotgun sequencing. If the hypothesis is confirmed this project may lead to bacterial therapies that will allow more patients tolerate metformin.

The purpose of this study is to estimate the extent to which supported exercise training through wearable technology and mobile application affects glycemic control in comparison to supervised exercise training in patients with Type-2 Diabetes.

1. People living with type 2 diabetes are told that they have a significantly higher risk of developing a disease related to the heart or blood vessels. These diseases can play a major role for the overall health of the patient and can even cause death due to a blood clot in the heart, brain or other parts of the body. Understandibly, this information can cause a great deal of stress and anxiety for the patient. As of today a doctor can not determine which patient has a higher risk of disease in the Heart and blood vessels. Therefore, we see a great need for further exploration of the mechanisms that could help identify diabetic patients with a particularly high risk of developing these diseases. In this PhD project we aim at identifying diabetic patients with a specific pattern in the amount of proteins in the blood, tissue and genetic material who are at high risk of death or disease related to the heart and blood vessels. We explore this problem from two angles. In the first part of the PhD study, we identify and measure proteins, which are related to high risk of disease in the heart and blood vessels. These proteins come from the blood vessels (a specific part called the basement membrane) and are believed to be present in a higher concentration, when people have diabetes. At the same time, we measure the same proteins in a blood sample from the patients, and we also examine their genetic properties with a focus on specific genetic areas. All the tissue and blood samples have already been collected from patients, who have undergone a by-pass operation in the Heart at Odense University Hospital since 2008. All of the material is stored in a biobank (Odense Artery Biobank). We also collect data from Statictics Denmark about each individual. These data are used to categorize people into risk categories. We then hope to see a pattern in the measurements from the laboratory that match the risk profile of the patient. In the second part of the study we use a different approach. Data from a large study done on the population of Malmö, Sweden, can be used to examine the Development of blood vessels in diabetic patients. In this study healthy people from Malmö have undergone a number of examinations in the early 1990'ies and again 15 years later. One of the tests was an ultrasound of the large blood vessel on the neck, the carotid artery. With this ultrasound we are able to measure the thickness of the wall of the blood vessel and the diameter in which the blood can pass through. We think that there is a connection between diabetes and the diameter of the blood vessel and that, over time, diabetes can cause the blood vessel to become narrower. This idea links the two studies because the same proteins that can be found in the first study are important in determining the risk of having a narrow blood Vessel when the patient has diabetes. 2. This project can contribute with a deeper knowledge about the linking mechanisms between diabetes and disease in the heart and blood vessels: which proteins are present in higher concentration? How does this relate to a higher risk? How do diabetic blood vessels change over time? We will aim at answering these questions. With regards to clinical practice, we see several perspectives: deeper knowledge and understanding of the mechanisms behind the diasease in the heart and blood vessels that follows diabetes development of a new blood test. Over time, the proteins measured in this study could be developed to a new blood test that gives information about a patients risk of developing a diasease in the heart or blood vessels better treatment for patients with diabetes because aptient with high risk can be treated more intensely In order to achieve the goals of this project there are several overall tasks: select patients form the biobank, that are suitable for the project (the correct type of tissue and blood sample available) do work in the laboratory. This includes cutting and preparing tissue, analyzing the tissue and blood samples, implementing new methods for analysis etc. collect clinical data form Statistics Denmark. This process can be quite detailed and time consuming. obtain data from 'The Diet and Cancer Study' in Sweden, Malmö analyze data from study 1 analyze data from study 2 write articles collect all parts of the projects in the final thesis

T2D is a global public health crisis and a threat to socioeconomic development of all nations, particularly in developing countries. Countries in the Gulf region, including the UAE, have some of the highest rates of T2D worldwide. The epidemic in the region has grown in parallel with the worldwide rise in obesity, which is fuelled by rapid urbanization, nutrition transition, and increasing sedentary lifestyles. Whether these unfavourable changes in environmental risk factors can explain the increased risk of T2D in the region, or whether the populations in the Gulf region are more genetically susceptible to disease is yet to be investigated. In this study, for the first time, the contribution of environmental, genetic, and epigenetic factors towards the increased risk of T2D amongst the population of the UAE will be investigated. This will be through, firstly, identifying environmental risk factors with higher prevalence rates, and bigger effect sizes on T2D in the UAE in comparison to Europe. Secondly, identifying genetic variants known to predict T2D in Europeans/other populations, but with stronger association with T2D in Emiratis. Thirdly, identifying novel genetic variants that are perhaps rare in Europeans/other populations, but confer increased risk for T2D in the UAE. Lastly, candidate genes underlying T2D pathogenesis via epigenetic mechanisms will be identified in Emiratis and Europeans. The end result is to identify the underlying candidate markers and mechanisms involved in T2D pathogenesis, which can better explain differences in magnitude of risk across populations.

The global incidence of diabetic nephropathy (DN) is increasing, with no appreciable reduction in the percent of patients progressing toward end stage renal disease (ESRD) and dialysis (Tuttle et al, 2014, Winocour et al, 2018). Therefore, identification of modifiable risk factors and early biomarkers of progressive decline in kidney function is an urgent clinical need. Phthalates are environmental and dietary contaminants with a various array of use that are identified in many consumer and industrial products; among them, di-(2-ethylhexyl) phthalate (DEHP) and its metabolites (mono 2-ethylhexyl phthalate (MEHP), 5OH-MEHP (MEHHP) and 5oxo-MEHP (MEOHP)) are widely used (Kato et al 2004, Braun et al, 2013). They partially distribute to the human tissues and their urinary and serum levels are directly related; therefore, urinary concentration of phthalates is commonly used as proxy of their exposure in humans (Kato et al 2004). While the association between phthalates exposure and development of T2D is currently being explored (Dong et al 2017, Dales et al, 2018), little is known about their role in DN. Recent observations show that DEHP and its metabolites are associated with a higher prevalence of low-grade albuminuria and in children exposed to higher phthalates concentrations (Trasande et al, 2014, Wu et al, 2018), however such association has yet to be verified in adults. The environmental ubiquity of the phthalates enhances the importance of investigating the potential relation between their exposure and different degrees of renal function. (Kato et al 2004, Kataria et al, 2015). Given this premise, the investigators will explore this potential association in a population of subjects with T2D consecutively referring to the outpatient diabetes clinic in Santa Chiara Hospital, Pisa, enrolled on a volunteer basis. During their routine visit at Santa Chiara Hospital outpatient diabetes clinic participants will provide the results of blood tests prescribed as per standard clinical practice along with a first morning, overnight fasting, urine sample collected in a phthalates-free container. The investigators will record the participants' clinical history, physical examination and anthropometric measurements, will measure their renal function, evaluated by eGFR (calculated with the CDK-EPI formula), albumin excretion, fasting glucose, HbA1c%, and the exposure to phthalates, assessed by total concentrations of MEHP, MEOHP, MEHHP and adjusted for urinary creatinine. In this way, the investigators aim to point out the relationship of urinary phthalates with higher degrees of albuminuria and/or lower eGFR after adjustment for all potential confounders, including therapies.

This single-blind, single-center, randomized, controlled trial is designed to evaluate the utility of the Chronicare Disease Management Program in the management of subjects with T2D who are being treated with insulin glargine and metformin. The Chronicare Solution comprises connected devices (a Bluetooth-enabled insulin pen sensor, a Bluetooth-enabled medication container, and a Bluetooth-enabled glucometer), a mobile smartphone app (CRx Health), an automated support system (Intervention Engine), and a remote care application (CRx Care) used by a team of clinicians to monitor and support patients.

The CUSTOM research project represents a complex intervention. The project aim of the intervention is, through the delivery of culturally sensitive Diabetes self-management education and support, to support ethnic minorities with type 2 diabetes in making health-promoting decisions about their care and gaining insight into their goals, values and motivation to improve their daily diabetes self-management. The target group comprises ethnic minorities whose native language is Arabic, Urdu or Turkish.

Multi-center, open, non-intervention and observational study to Evaluate the efficacy and safety of Suganon tab. or Sugamet XR tab. in patients with Type 2 diabetes

This study is designed as a prospective, observational, multi-centre study to evaluate the efficacy and safety of Teneligliptin when switched from other DPP-4 inhibitors in type 2 DM with inadequate glycemic control