View clinical trials related to Diabete Mellitus.
Filter by:The primary objective of this clinical trial is to assess the clinical efficacy and safety of the Buyuan Zhixiao Formula in treating elderly patients with diabetes and multiple metabolic disorders exhibiting symptoms of renal deficiency and blood stasis. Furthermore, this study aims to intervene in high-risk factors to prevent arteriosclerosis and to investigate the clinical efficacy of the Buyuan Zhixiao Formula in the prevention and treatment of cognitive impairments. The main questions it aims to answer are: 1. What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity? 2. Can Buyuan Zhixiao Formula improve cognitive impairment in diabetes? Researchers compared Buyuan Zhixiao Formula with a placebo (a drug that looks similar but contains only 10% of the active ingredients) to see if the drug Buyuan Zhixiao Formula can treat elderly people with diabetes and multiple metabolic disorders. Participants will: 1. Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months；Follow-up for 6 months； 2. Check fasting blood sugar and 2-hour postprandial blood sugar every month; check HbA1c, blood lipids, vascular function, and cognitive impairment serum markers every 3 months; 3. Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events; 4. Urine and serum samples were collected before and after treatment;
This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures.
Diabetes is a chronic condition that affects around 8% of the French population, and is associated with severe complications. Maintaining a constant blood glucose level of between 0.7 and 1.80 g/l is the day-to-day objective of diabetic patients.Insulin can be administered by injection via syringes or pens, or by insulin pumps and patients can perform self-monitoring of blood glucose. All these actions can be the subject of therapeutic education, which involves a range of tools, including dedicated individual consultations carried out by state-qualified nurses. The aim of the study is to evaluate the benefit of therapeutic education consultations conducted by nurses in addition to medical consultations, on the follow-up of diabetic patients, insulin pump carriers or treated with multiple injections, in terms of glycemic control, quality of life and medical complications. The objective of the study is to evaluate whether the therapeutic education consultations conducted by nurses can improve the care of the diabetic patient.
Objectives The aim of this intervention is to assess how well and how efficiently the O2O Service Model works in delivering primary healthcare and managing chronic diseases for patients living in Pyeongchang-gun at the local government level. Trial design This is a randomized controlled trial with restricted, batch, blocked and individual random assignment. Investigators will allocate 1,000 participants from Pyeongchang-gun into two groups: one with diabetes (and pre-diabetes) and one with hypertension (including borderline cases), focusing on poorly controlled patients. As participants visit local health centers, their data will be sent to the research team for blocked randomization based on disease type, severity, and region. Assignment results will be communicated back to the centers and patients. Study setting The intervention will take place in Pyeongchang-gun, Kangwon-do, South Korea. The Smart Healthcare Center affiliated to Public Medical Center of Pyeongchang will primarily manage the O2O service by providing necessary education and human resources while receiving and monitoring data from each participant and local medical centers. The overall study (including the design of trial) is managed by Seoul National University College of Medicine while the provision of O2O service and data collection are primarily in charge of Smart Healthcare Center of Pyeongchang. Intervention in O2O Service Model: After initial health exams, each patient gets a custom care plan, classifying their disease and care level. The Pyeongchang Smart Healthcare Center, with doctors, tracks patients via an online platform, sending automated health messages. High-risk patients receive a two-week glucose monitor and guidance on lifestyle adjustments. Doctors access patient health records through the participant's personal online datastore (POD), with consent, integrating health and prescription history from national insurance, and can assess heart disease risk. Sample size The trial's sample size is determined using the MDES(Minimum Detectable Effect Size), with 1,000 participants divided equally between diabetes and hypertension groups. Each group is then split into treatment and control subgroups through random allocation. The MDES calculation, accounting for an explained outcome variation of 50% due to blocking and controls, and based on 500 subjects per group with equal allocation, aims for a high-accuracy effect size of 0.216 at a 5% significance level and 80% power. Assignment of interventions: allocation Participants will be randomly placed into groups by a computer program. This study uses a specific randomization method that is restricted and organized by individual characteristics. The research team will tell the centers and patients about their group assignment via phone and email. Neither the healthcare staff nor the participants will know the group allocation beforehand. The research team is in charge of the randomization process and informing everyone involved. The staff at Pyeongchang's Smart Healthcare Center will sign up participants and manage their placement into the assigned intervention groups. There will be no blinding after participants are assigned to their groups. List of Data For the study, the investigators have created questionnaires and interview formats to collect various data types, including random assignment records, baseline information, outcomes, service usage and costs, demographic and health details, physician-collected health records, life-log data from apps or web, clinical exam results, and service effectiveness and efficiency from the perspective of medical staff and administrators. Statistical methods For the analysis of primary and secondary outcomes, the investigators will employ ITT(Intention-to-Treat) and Regression-Adjusted Impact Estimate. When data allows (especially data from control group), the investigators will also conduct timeseries effect analysis. To investigate the time-series changes in program effects across multiple time points, the dependent variable (outcome variable) should be measured at each time point to estimate program effects repeatedly. Data management and monitoring The data management for the study will be conducted using electronic systems for secure and accurate data entry, coding, and storage, with robust checks and backups to ensure data quality, which will be archived for three years in compliance with bioethics standards before disposal according to privacy regulations. Participant confidentiality is prioritized through secure data collection and restricted access, with sharing only to authorized research team members and regulators using password protection or encryption. Additionally, a dedicated Data Monitoring Committee will oversee trial progress and adherence to protocols, while the Smart Healthcare Center collaborates with healthcare workers to manage patient services, with minimal adverse events expected.
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions ranging from liver steatosis (NAFL), steatohepatitis (NASH), advanced liver fibrosis and ultimately leads to cirrhosis in a significant proportion of individuals. NAFLD is intimately associated with insulin resistance and associated disorders, such as obesity, type 2 diabetes, metabolic syndrome, and dyslipidemia. It has been noted that several individuals with liver transplantation develop nonalcoholic fatty liver disease in the transplanted liver. This is because of the presence of various risk factors of obesity and NAFLD, such as decreased physical activity, that persist following liver transplantation. Post-liver transplant patients are particularly at risk for developing NAFLD, as these patients are on oral steroids and immunosuppressants for a significant period of time. There is no medication approved for the prevention or treatment of NAFLD. Semaglutide is an GLP-1 receptor agonist that have been approved for the treatment of type 2 diabetes and obesity. Semaglutide has also been demonstrated to have beneficial effects on NAFLD. However, there is no data on the effect of semaglutide on liver fat accumulation or changes in body composition in patients following liver transplantation. Therefore, the current pilot study is planned to evaluate the effect of oral semaglutide on the liver fat, liver enzymes and body composition in patients undergoing liver transplantation
Hospitalized patients with severe COVID-19 have an increased incidence of insulin resistance, impaired beta cell function, glucose intolerance (prediabetes), and overt type 2 diabetes (T2D) compared to non-hospitalized patients with COVID-19 and COVID-19 negative individuals on long-term follow up.
Type 2 Diabetes mellitus (T2DM) is a chronic disease with a high prevalence and several comorbidities impacting on public health and society. Among the complications of T2DM it has been showed a high prevalence of hypogonadotropic hypogonadism. Even if hypogonadism is associated to a worse metabolic profile and cardiovascular risk, it is discussed whether and when to treat this potentially reversible form associated to diabetes. In fact, the pathogenic mechanism of this condition in diabetic patients is not fully understood, and its clinical correlates, including the prevalence of other possible associated hypothalamic-pituitary axes dysfunctioning, questioned. The aim of the present study is to assess with an observational, cross sectional study on a large series of type 2 diabetic patients, enrolled consecutively: all the suspected etiologies of this complication in one single evaluation (both acquired and genetic congenital predisposition), its clinical correlates and the real prevalence of the disease using the lastly validated criteria for late onset hypogonadotropic hypogonadism.
The study will be conducted on women with risk factors for SSI assigned to gynecological surgery with an open abdominal approach. The participants will be designated to either Irrigation and suction arm by bilateral drain insertion or the control arm by randomization through the parallel assignment. The participants will be followed for the outcome for four days in the hospital and then at 4 weeks, 8 weeks and 12 weeks postoperatively. The primary outcome measure will be the SSI rate. Secondary outcomes will be signs of SSI, post-operative pain, other complications and patient satisfaction.
The investigators aim to objectively identify the Traditional Chinese Medicine (TCM) syndrome differentiation of type II diabetic and prediabetic patients in Singapore through modern technologies thereby potentially increasing the accuracy of identification, diagnosis, and prevention of diabetes and prediabetes through a system of targeted treatment. This observational study integrates the concept of TCM diagnostic methods with modern tools aim to provide an objective view on the syndrome differentiation of diabetic and prediabetic patients in Singapore and hence provide a guideline in the treatment options targeted specifically at Singaporeans demographic. A total of 250 subjects with 50 allocated in each group will be recruited to ensure a sufficient sample size for statistical analysis of the diabetic and prediabetic syndrome differentiation. Subjects aged 21-65 years old, of either gender, with no limitations on race, and is diagnosed with either diabetes (FPG ≥ 7.0 mmol/L, or 2hPG ≥ 11.1mmol) or prediabetes (IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L) will be included. Subjective and objective assessments through health evaluation, Physical Activity Questionnaire and Sugar Intake, Constitution in Chinese Medicine Questionnaire, radial pulse diagnosis and tongue diagnosis will be performed for each subject in a single visit. Statistical analysis of assessments will be conducted using unpaired t-test with significance level of p<0.05. Statistical software SPSS 15.0 (SPSS Inc.) will be used for the analysis.
This randomized controlled trial will investigate whether use of continuous glucose monitoring (CGM) vs. usual care with self-monitored blood glucose 1) enhances glycemic control, 2) reduces hypoglycemia risk, and 3) improves quality of life, diabetes distress, and fear of hypoglycemia in hemodialysis patients with diabetes mellitus.