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Browse 7,874 clinical trials for diabetes. Find studies that match your criteria and connect with research centers.
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NCT02423434
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.
NCT02221284
The purpose of this survey is to evaluate the safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues)\* in addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine medical care. \* Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use surveys for alogliptin tablets.
NCT00826904
The purpose of this study is to determine whether unrecognized maternal hyperglycemia and postprandial lipemia early or late in gestation predicts excess neonatal adiposity.
NCT03823027
The primary objective of STAR01 is to evaluate the performance and safety of the medical device (class IIb) SiPore15™ after a 12-week long treatment in the target population of obese and overweight subjects with prediabetes or newly diagnosed type 2 diabetes. The expected performance and safety of the device is based on the safety and efficacy results seen in an earlier First-in-Man (FIM) study. The safety and tolerability of SiPore15™ is based on the well-established and extensive use of food grade silicon dioxide and favorable data from the FIM study. Data on side-effects will be collected for verification of device safety. The study duration is 24 weeks in total, 12 weeks from baseline on investigational medicinal device (IMD) treatment, with additional 12 weeks off treatment. The study population is planned for forty (40) subjects to be enrolled, male and females, age \>18 years and fulfilling all inclusion criteria but none of the exclusion criteria.
NCT04150315
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
NCT04149067
The aim of this study is to develop a retrospective, multicenter and observational study in Spain in real clinical practice to assess the employment of dapagliflozin and to compare its effectiveness and safety with the data of sitagliptin, a DPP4 inhibitor. This is a widely used molecule in Spain with a large safety profile. It was chosen as a comparator because of the number of patients treated and because it is a real alternative at the time of making a decision about the treatment.
NCT02533648
Our recent data in mice have demonstrated a key role of xanthine oxidase in hyperglycemia-induced by Reactive oxygen species production, and a preventive role of allopurinol (inhibitor of xanthine oxidase) on the keeping of mitochondria number and structure, in skeletal muscle of diabetic mice. The investigators want to initiate a clinical trial in order to evaluate the efficacy of allopurinol on the improvement of mitochondrial alterations, oxidative capacities and insulin sensitivity, in skeletal muscle of type 2 diabetic patients.
NCT01241253
The study uses a randomized, placebo-controlled experimental design consisting of 4 different test treatments matched on carbohydrate (CHO) content. The three beans are similar in their CHO content amount for ½ cup at \~20 grams CHO. Each of the bean varieties will be served in a \~½ cup serving size with \~ ½ cup of plain steamed white rice (30 grams CHO) for a total of 50 grams of CHO per meal for each of the three test treatments. The 4th placebo or control treatment consists of \~ 7/8 cup of rice alone, an amount consistent with the CHO content of the test meals. Most diabetic meal plans recommend no more than 45-60 grams of CHO per meal. Fifty grams of CHO is a standard amount for glycemic response testing in general. The investigators hypotheses were: * The test meals containing the three bean types in combination with white rice will decrease the participants' glycemic response when eaten as part of a meal. * The reduction in post-prandial glycemia will not differ between bean types in the elicited responses among individuals with type 2 diabetes.
NCT03906201
Prediabetes is the term used for people whose glucose levels do not meet the criteria for diabetes but are too high to be considered normal. This is defined by the presence of blood glucose between 100-125 mg / dL, values per glucose tolerance curve of 140-199mg / dL and/or HbA1c 5.7-6.4%. Prediabetes should not be considered as a clinical entity in itself, but as a risk factor for diabetes and cardiovascular disease (CVD). Prediabetes is associated with obesity (especially abdominal or visceral obesity), dyslipidemia with elevated triglycerides and/or low HDL cholesterol, and hypertension.
NCT04144920
This study aims to determine the most effective strategy of reducing sedentary behavior to improve health. Specifically, we aim to answer the following questions: (a) To determine if there is a significant difference in acute post-prandial glucose response between continuous sitting and two intermittent standing regimes (high frequency, low duration breaks (HFLD) and low frequency, high duration breaks (LFHD)). We hypothesize that intermittent standing (combined HFLD breaks and LFHD breaks regimes) will result in lower overall acute post-prandial glucose compared to continuous sitting. (b) To determine if there is a significant difference in acute post-prandial glucose response between two strategies to reduce sitting with standing (HFLD standing breaks vs. LFHD standing breaks). We hypothesize that the HFLD breaks condition will elicit lower acute post-prandial glucose level compared to the LFHD breaks condition. All eligible participants will be consented and subjected to all three study conditions: (i) Uninterrupted sitting, (ii) HFLD breaks, and (iii) LFHD breaks. The order at which participants were subjected to these conditions will be randomly determined and each condition were performed a week apart. Standardized meals (breakfast and lunch) will be provided during each lab visit and participants will be then be asked to perform their usual work activity using a sit-stand workstation in the lab. Depending on their assigned condition, the participants will be prompted to stand or sit for a given period of time. A continuous glucose monitor will be used to measure glucose response to the intervention while an activPAL device will be used to make sure that participants are compliant with the study protocol.
NCT02371876
The purpose of this study was to determine if untrained subjects with diabetes can operate the Investigational ONYX PLUS Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
NCT02920918
Investigator Initiated Study to study the effects of Canagliflozin 100 milligrams (mg) vs Sitagliptin 100 mg on parameters of aerobic exercise capacity (peak oxygen consumption \[VO2\]) and ventilator efficiency (minute ventilation \[VE\]/carbon dioxide production \[VCO2\] slope) at cardiopulmonary exercise test (CPET) after 12 weeks of active treatment (primary endpoints). Blood pressure (BP), body water content, body composition, cardiac function, and diet will be also measured (secondary endpoints).
NCT02412774
The purpose of the present study is to evaluate the effect of replacing diet beverages with water on weight loss and biochemical indicators for insulin sensitivity and cardiometabolic risk factors of diabetic obese and overweight female adults when they are in a multidisciplinary weight loss plan.
NCT04139369
Type 1 Diabetes Mellitus (T1DM) is a well-studied autoimmune disease resulting in insulin deficiency due to selective β-cell destruction. Epigenetics is a novel field of biology studying the inherited changes in deoxyribonucleic acid (DNA) expression which cannot be attributed to base sequence alteration. A relatively limited number of studies are published until now concerning T1DM in children and adolescents addressing epigenetics changes in DNA expression. The purpose of the present study is to analyze the methylation status of DNA within the promoter region of specific susceptibility genes such as Protein tyrosine phosphatase, non-receptor type 22 (PTPN-22), Insulin (INS) and Human leukocyte antigen G (HLA-G) genes.
NCT02121717
The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with placebo.
NCT02344433
A Relational Agent (RA) "virtual counselor" (VICKY: VIrtual Counselor for Knowing Your Family History) has been developed to collect family health history information for common health conditions including heart disease, stroke, diabetes, hypertension and various cancers. In this study, the investigators will conduct a randomized controlled trial (RCT) to compare the efficacy of using VICKY to the existing My Family Health Portrait (MFHP) tool for collecting family health history information among an underserved primary care patient population. The primary aims of the study are to 1) evaluate the efficacy of VICKY versus MFHP for collecting accurate family health histories and 2) determine whether accuracy varies as a function of health literacy. This project will obtain validation data on the efficacy of both VICKY and MFHP for collecting accurate family history data among an underserved patient population, in two languages (English and Spanish). The study will determine whether a virtual counselor can overcome many of the existing barriers to using traditional web-based family history tools.
NCT03462420
This pilot randomized trial will compare the preliminary effect of a regular physiotherapy (PT) program to a regular PT combined with a progressive walking program (PT+) in patients with and without diabetes who have adhesive capsulitis. After signing the consent form, recruited participants will be randomized into either PT group (control) or PT+ group (experimental). Participants in both groups will be referred to a physical therapy facility. The intervention will be chosen by treating physical therapist. In PT+ group, participants will also be asked to perform free walking at their own pace. Outcomes measures for the primary outcome (shoulder functional performance) will be evaluated at baseline and after 6 weeks. Secondary outcomes (shoulder ROM, pain and function, muscle strength, and physical activity level) will be evaluated at baseline, at 3 and 6 weeks, and again at 12 weeks after enrolment. We expect adding a progressive walking program to regular PT will result in better outcomes.
NCT02066766
This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Vietnam.
NCT02590016
Pregnant women with gestational diabetes who are treated with insulin and their daily insulin dose is 30 IU or more will be randomized into two groups. Active treatment group will receive insulin-glucose-infusion during labour. In the observational group, blood glucose level during labour will be monitored and insulin-glucose-infusion is started only if needed. The hypothesis is that there will not be a difference in rate of hypoglycemia between the two groups and that the proportion of observational group participants that need infusion is low.
NCT03542071
eMOM is a randomized, controlled trial to compare the effects of two different dietary interventions during pregnancy. The comparison is based on tissue glucose content (using continuous glucose monitoring system) in pregnant women and on neonate body composition. The recruited women (n=50) have early gestational diabetes mellitus (diagnosed before gestational weeks 13), are obese (BMI \>30 kg/m²) and of Caucasian origin. Of the study diets, one is moderately carbohydrate restricted and the other one is high on plant-based protein with an emphasis on healthy Nordic foods. The study has three two-week study periods that are carried out on approximately gestational weeks 13-14 (period I), 24-25 (period II) and 34-35 (period III). Continuous glucose monitoring and other measurements (accelerometer, 3-day food record, gut microbiota, serum lipids, metabolomics, epigenetics etc.) are done during these study periods. At the beginning of the study, before study period I, the participants are randomized to either one of the intervention diets. The first study period consists of a crossover phase in which the participants receive three days' worth of food according to one of the intervention diets (according to the randomization) after which there is a three-day wash-out period. After the wash-out period, the participants receive three days' worth of food according to the other diet. After the first study period, a nutritionist advises the lastly followed intervention diet to the participant and the diet is followed until delivery. To ensure the diet is followed, the participant gets at least five personal counselling sessions, mobile reminders, recipes and food items. After delivery, the infant's body composition, epigenetic markers of cord blood and placenta, gut microbiome and urine metabolomics are measured.
