Cities In Spain, Spain
Manual Diaphragmatic Release on Ventilatory Functions in Elderly Diabetic Women
Sixty elderly type 2 diabetic women were sourced from the endocrinology outpatient clinic at Mansoura University hospitals in Egypt, with referrals from endocrinologists. Patients were randomly assigned into two groups. The study group includes 30 women participating in manual diaphragmatic release plus aerobic training for 12 weeks, while the control group includes 30 women participating in aerobic training only for 12 weeks. At baseline and poststudy, the following outcomes are assessed: 1. Ventilatory functions (Forced vital capacity and forced expiratory volume in the first second). 2. Functional capacity using modified Bruce treadmill incremental exercise test (Maximal oxygen consumption estimation).
Phase
N/ASpan
22 weeksSponsor
Cairo UniversityRecruiting
Interprofessional Pharmacogenomics (IPGx) Registry and Repository
This study wants to understand how genes can affect how the body responds to medicines. This information will help us determine whether changing your medicine can make you healthier and improve your life. We will study your medical history for the last year and the next five years after you join the study. study goals include: - Enrolling patients who take multiple medications or have harmful side effects from their medications. - Keeping all medical information and genetic samples from patients in one place. - Helping doctors make better decisions about which medicines to prescribe. - Influencing insurance companies and the government to help pay for this kind of medical care for people who need to change their medicine to stay healthy.
Phase
N/ASpan
257 weeksSponsor
Texas A&M UniversityRecruiting
Safety and Efficacy of OCN19-overexpressed Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Refractory Type 2 Diabetes Mellitus
Phase
2Span
319 weeksSponsor
Lu jin ,MDRecruiting
Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes
Phase
2Span
200 weeksSponsor
Mostafa BahaaRecruiting
To Understand the Self-care Ability of Farmers and Fishermen With CMDs (Hypertension, Heart Disease, Hyperlipidemia, Type 2 Diabetes), Whether They Are Aware of CMDs, Their Treatment Status, Treatment Effectiveness, and Their Ability to Describe Known and Practice the Self-care Content of CMDs.
Research background: In addition to emphasizing three-stage and five-level prevention strategies, community nursing is also expected to demonstrate innovative capabilities and initiatives in health equality and climate change response in sustainable development. Agriculture and aquaculture are an important development of the country, the foundation of people's life and ecological conservation; Taiwan's southwestern coast is an important base for providing high-quality agricultural and fishery products to the people, accounting for one-third of the households and people engaged in agriculture and fishery in the country. However, with international economic and trade pressures and climate change, the number of these farmers and fishermen is decreasing year by year as they face declining production capacity and income. According to the preliminary research results of our team, the prevalence and mortality rate of cardiometabolic diseases among farmers and fishermen along the southwestern coast are higher than those in the country and advanced countries in Europe and the United States. At the same time, the rate of chronic dehydration is also high. Overall farmers and fishermen have low education levels, are aging, and lack medical resources. Relatively inadequate. Literature shows that if people with cardiometabolic diseases improve their self-care abilities, they can avoid health deterioration such as myocardial infarction and stroke. From the perspective of assisting the sustainable development of agriculture and fisheries, how to overcome the health inequalities caused by social factors determining health? Through The focus of this project is to provide innovative strategies that are consistent with their socio-economic background and to effectively improve their self-care abilities and chronic dehydration problems. In the past, our team has gradually reduced the incidence of liver cancer and other related cancers in the region through the detection, referral and treatment of type C virus hepatitis with a high prevalence in the region. It has also provided the Ministry of Agriculture with relevant health needs and policy initiatives for farmers and fishermen, and has gained a lot of popularity. The trust and attention of relevant units will help us continue to promote cross-domain cooperation. So far, there is a lack of relevant literature at home and abroad to explore and improve the health problems of farmers and fishermen; there is even less research on community nursing to prevent and improve the worsening of cardiometabolic diseases. Research purpose: Therefore, this project will be based on the results of previous research to conduct the following discussions: (1) the self-care ability of farmers and fishermen with cardiometabolic diseases; (2) designing a design that is consistent with the socio-economic background of farmers and fishermen to improve their self-care Ability teaching materials and teaching aids; (3) Verify the effectiveness of this teaching materials, teaching aids and the experimental design of this study, as a basis for industry-university cooperation with local governments and private enterprises, in order to achieve the influence of benefit diffusion. Research methods and objects: This project will be based on the self-care theory of nursing scholar Dorothea Orem, combined with the concept of the eight key elements of life [life essential 8, LE8] proposed by the American Heart Association, and the research results of our team in recent years, to construct a structure that is suitable for this group Teaching materials and teaching aids for [Self-care - Octathlon]. This project is expected to be completed in three years. In the first year, a cross-sectional descriptive research method will be used to target farmers and fishermen on the southwest coast. It will cooperate with the Health Bureau and regional hospitals to identify farmers and fishermen with existing cardiometabolic diseases and carry out self-care. To discuss ability, chronic dehydration and its influencing factors, the sample size is estimated to be approximately 338 people. The research methods and purposes in the second to third years are: (1) Complete [board game] teaching aids that meet the socio-economic and cultural background needs of farmers and fishermen, and train seed teachers; (2) Community-based quasi-experimental research design, select Participants in the conditions were randomly assigned to the intervention group and the control group in clusters. Participants in both groups received the [Self-Care-8thlon-SC-8] teaching materials; the intervention group also received the [SC-8-Monopoly Board Game] program. After adopting the conventional community care model with the control group, the differences in self-care ability, cardiometabolic and inflammatory indicators are estimated to be approximately 205 in both groups at this stage. Use descriptive and inferential statistical analysis, such as chi-square and variance tests, multivariable linear, logistic regression and generalized estimating equations, to process repeated measurement data and adjust the effects of influencing factors. Analysis: The study will employ both descriptive and inferential statistical analyses, such as chi-square and analysis of variance (ANOVA), multivariate linear regression, logistic regression, and generalized estimating equations (GEE) to handle repeated measures data and adjust for the effects of influencing factors. Expected results: This study will be able to present an overview of the self-care ability of farmers and fishermen with cardiovascular and metabolic diseases, as well as the distance from ideal and related influencing factors, establish self-care teaching materials and teaching aids suitable for the socio-economic background of this group, and transform it into a reliable Through the completion of patents and technology transfer, the [board game] teaching aids with validity and entertaining functions are expected to be used as convenient and effective guidance tools for health bureaus and primary medical care units.
Phase
N/ASpan
139 weeksSponsor
Chang Gung Memorial HospitalRecruiting
Jockey Club Precision Prevention Programme on Young Onset Diabetes
BACKGROUND AND RATIONALE: In Hong Kong, 1 in 10 adults have diabetes. In hospital-based clinic setting, 1 in 5 adults with diabetes were diagnosed before the age of 40, i.e. young-onset diabetes (YOD). The latter is the major driver of recurrent hospitalizations, critical illnesses and premature death. Compared to fasting plasma glucose (FPG) or HbA1c, 2-hour PG is needed to detect impaired glucose tolerance (IGT) and diabetes (DM). Besides, 2-h PG is more robust than FPG or HbA1c in predicting major events and death. The selection of participants with IGT for intervention is based on the positive effects of lifestyle modification and metformin only in individuals with IGT and not in individuals with isolated IFG in randomized clinical trials. Besides, there is strong familial tendency of YOD and based on our published and in-house 20-year prospective data in a workforce, 80% of people who developed DM came from 20-30% of individuals with high genetic risk unmasked by modifiable risk factors such as obesity and smoking. In this implementation project, investigators shall use a 2-stepped approach to identify adults aged between 18 and 44 (inclusive) with genetic predisposition to undergo yearly OGTT to diagnose IGT and diabetes early for intervention. Investigators shall apply the proprietary DForesee (DF) risk algorithm including clinical and biogenetic risk factors to select the top 25% of participants at the highest risk for IGT or diabetes in next 10 years to undergo yearly OGTT accompanied by a risk-based intervention program. STUDY DESIGN AND METHODS: By using quasi-experimental design based on an evidence-based multi-component strategy, investigators aim to detect and delay the onset of diabetes in adults aged less than 45 years. Investigators aim to identify 9,000 adults aged between 18 and 44 years (inclusive) in community- and clinic settings during a 2-year period, followed by 2 years of risk-stratified intervention. Investigators shall use clinical and biogenetic assessment including DNA testing, capillary blood test and administration of questionnaires to classify participants to high risk and low risk progressors. All participants will receive risk-based intervention. Low risk progressors will receive a personalized report indicating their genetic and modifiable risk explained by nurses and with repeated clinical and biogenetic assessment at year 2. The high risk progressors will additionally undergo annual oral glucose tolerance test to detect diabetes and impaired glucose tolerance (IGT) and will receive a personalized report explained by doctors. All participants will be offered regular access to webinars for education and empowerment for 2 years. The high risk group will additionally receive a 2-year risk-stratified intervention with different combinations of care interventions. These include clinical and laboratory assessment for comprehensive evaluation of cardiovascular-kidney-metabolic risks, medical and nurse consultations, empowerment by health messages, webinars, face-to-face workshops, subsidies for medications and self-monitoring tools (e.g. CGM devices for IGT and DM groups only, weighing scale for all high risk progressors) to motivate behavioural change. INCLUSION and EXCLUSION CRITERIA Age 18-44 (inclusive) years without known diabetes, at least one risk factor for diabetes and with usual place of residence in Hong Kong, The risk factors for diabetes include central or general obesity, family history of diabetes, smoking history, history of hypertension, high blood glucose level, abnormal lipid level/ vascular disease, or fatty liver, history of gestational diabetes polycystic ovary syndrome or delivery of baby≥ 4kg (for women only), less than 150mins of physical activity every week. People with known diabetes or conditions considered to be unsuitable by the project team including illiteracy will be excluded. OUTCOME MEASURES The outcomes will be analysed within the REAIM framework (reach, effectiveness, adoption, implementation and maintenance), progresssion to prediabetes or diabetes, patient reported outcomes and cost effectiveness.
Phase
N/ASpan
184 weeksSponsor
Juliana CN ChanRecruiting
Healthy Volunteers
I Can Do This! Managing My Diabetes
Diabetes poses a significant public health challenge in the U.S., affecting approximately 37 million people, or 11% of the population. The prevalence is rising, particularly among youth, with a forecasted 700% increase in type 2 diabetes cases by 2060. Diabetes leads to severe health complications, including increased risks of heart attacks, strokes, and kidney failure, and affects nearly 1 million people worldwide with vision loss. Many individuals struggle to manage their diabetes effectively; only about 50% achieve proper glycemic control. Diabetes self-management education is crucial for improving self-efficacy and adherence to treatment, yet only 5-7% of eligible patients receive this education. The American Diabetes Association advocates for individualized nutrition therapy, but access remains limited, especially for uninsured populations, exacerbating health disparities. To address this gap, a novel word game-based workbook is proposed to enhance diabetes self-efficacy. This workbook can be used in waiting rooms or at home, offering an engaging way to learn about diabetes management through word games and puzzles. It aims to provide accessible education for underserved communities, improve glycemic control, and ultimately reduce diabetes-related disparities.
Phase
N/ASpan
35 weeksSponsor
Emory UniversityRecruiting
Effect of Reiki on Neuropathic Pain Severity and Sleep Quality in Patients with Diabetic Neuropathy
Research hypotheses; H01: Second-level Reiki applied to patients with diabetic neuropathy for 20 minutes once a day for 4 days has no effect on reducing pain intensity. H11: Second-level Reiki applied to patients with diabetic neuropathy for 20 minutes once a day for 4 days has an effect on reducing pain intensity. H02: Second-level Reiki applied to patients with diabetic neuropathy for 20 minutes once a day for 4 days has no effect on reducing neuropathic pain intensity. H12: Second-level Reiki applied to patients with diabetic neuropathy for 20 minutes once a day for 4 days has an effect on reducing neuropathic pain intensity. H03: Second-level Reiki applied to patients with diabetic neuropathy for 20 minutes once a day for 4 days has no effect on sleep quality. H13: Second-level Reiki applied to patients with diabetic neuropathy for 20 minutes once a day for 4 days has an effect on sleep quality. Reiki/Sham Reiki Application Protocol After the assignment of patients with diabetic neuropathy to the groups by lot, the Reiki group will be applied remotely by a researcher who has received second-level training, and the Sham Reiki group will be applied remotely by a nurse who is not a Reiki practitioner trained by the researcher and has not received any training before, in accordance with the application protocol. Research Groups Intervention Group-1 A 20-minute remote Reiki application will be applied once a day for four days by a researcher who has received second-level training. No changes will be made to the standard treatment plan of the patients during the application. Intervention Group-2 A 20-minute remote Sham Reiki application will be applied once a day for four days by a nurse who has not received Reiki training and has not been initiated. No changes will be made to the standard treatment plan of the patients during the application. Control Group No application will be applied to the patients for four weeks. Individuals will continue to receive their normal treatments.
Phase
N/ASpan
61 weeksSponsor
TC Erciyes UniversityRecruiting
Diabetes-specific Formulas on Nutritional Outcomes in Individuals With Diabetes and at Risk of Undernutrition
This is a randomized, double-blind, parallel, non-inferiority study. Eligible participants will be randomly allocated (at 1:1 ratio) to one of two groups: DSF1 (experimental group) or DSF2 (control group). Both groups will incorporate one serving of the DSF into their daily diet, in addition to receiving standard of care for diabetes. The total expected duration of the study is up to 104 days, including a run-in period of up to 14 days, followed by an intervention period of 90 days. At Day 1, participants will be randomized into one of the two groups (n = 50 per group): DSF1 or DSF2. Participants will start the intervention on Day 1 and complete the intervention on Day 90.
Phase
N/ASpan
57 weeksSponsor
Abbott NutritionRecruiting
Increasing CGM Use Among Patients With T2D
Background & Significance: Approximately 30 million adults in the U.S. suffer from diabetes, a chronic condition with serious long-term health and social consequences. Diabetes is a leading cause of death and disability across the country that disproportionately burdens minoritized ethnoracial, low-income, and rural populations-such as in the border-area region of Imperial County, CA where diabetes rates far exceed state and national averages.Continuous glucose monitoring (CGM) is increasingly recognized as a valuable tool for patients with Type 1 and Type 2 Diabetes (T1D and T2D, respectively), with use of the technology associated with improved disease management, reduced diabetes distress, and healthcare costs. Unfortunately, while clinical practice guidelines recommend use of CGM in diabetes care, inequities in CGM use threaten to exacerbate existing diabetes disparities. For instance, patients from minoritized ethnoracial groups, particularly Hispanic and Black patients, are less likely to use CGM than non-Hispanic white patients. Disparities in CGM use may be attributed to a variety of factors; However, the most common barrier reported by both patients and providers is limited uptake due to perceived cost. Research has shown that providers may not prescribe CGM due to concerns about costs and their lack of knowledge about insurance eligibility requirements. Fortunately, recent expansions in insurance coverage mean costs may no longer prohibit access to CGM for low-income patients who meet clinical eligibility criteria. Notwithstanding, many providers may not prescribe CGM even to those who qualify for coverage. This may be particularly true among primary care providers who increasingly serve as the primary point of care for patients with diabetes living in rural and medically underserved areas without access to an endocrinologist. A study of over 600 HCPs showed that only 38.6% had ever prescribed CGM, but nearly two-thirds said they would be likely to do so with increased education on CGM or consultation on insurance requirements. Thus, educating HCP on current CGM clinical practice recommendations and insurance coverage eligibility requirements could greatly improve CGM prescriptions in clinics serving low-income and ethnoracially diverse patients. While increasing CGM prescriptions is an important step to providing more equitable access to CGM, additional intervention may be needed to ensure patients from historically marginalized communities can access and use the devices. More specifically, once prescribed, CGM effectiveness is contingent on patients' acquiring, applying and using the device. Research has shown that patients may share their providers' uncertainty over coverage eligibility requirements and out-of-pocket costs associated with CGM use; a study of over 1,500 patients with T1D found the most reported concerns about using CGM were insurance coverage and costs. If not addressed, cost concerns could impede patients from acquiring CGMs even if prescribed by their healthcare provider (HCP). Given the potential impact of CGM on diabetes management, efforts to increase CGM uptake are critically needed, especially in historically marginalized and under-resourced regions without access to diabetes specialty care. Strategies such as educating HCP on current CGM eligibility criteria and insurance costs and improving patient education on costs may be effective in increasing initial CGM uptake and ultimately improving patient outcomes. However, no prior studies have evaluated the impact of these strategies in low-resource, primary care settings, or with Hispanic/Latino patients. Existing studies have also primarily focused on CGM use and impact in patients with T1D rather than T2D. The proposed project will fill this gap by evaluating the impact of a system-level, provider-focused intervention on CGM prescription rates and diabetes outcomes for eligible patients with T2D of a large Federally-Qualified Health Center in Imperial County, California. The project will be guided by the following aims: 1.Determine whether the proportion of T2D patients who are prescribed CGM significantly increases following a system-level CGM intervention that is implemented sequentially in three different clinics. HCPs and staff will participate in a training and receive a CGM prescription toolkit, including procedures for determining clinical eligibility, insurance documentation templates, scripts for communication with patients, and patient education materials with information about CGM benefits, how and where to acquire the device, and any anticipated out-of-pocket costs. CGM prescription rates will be extracted from electronic health records (EHR) to determine changes over time. H1: CGM prescription rate for T2D patients will increase significantly after the intervention. 1a: Evaluate impact of toolkit training on knowledge and attitudes towards CGM among HCP/Staff. H2: Knowledge and attitudes towards CGM will significantly improve following completion of the toolkit training. 2. Compare changes in A1C values over time between T2D patients who do and do not receive a CGM. A1C values will be extracted from the EHR to compare changes over time among patients with T2D who received and filled a new CGM prescription vs. never received or did not fill their prescription. H0: Patients who use CGM will show significantly greater improvement in A1C values over 6 months compared to those who did not use CGM. 2a. Determine whether the impact of CGM use on A1C is mediated by changes in diabetes distress. H2: Reductions in diabetes distress will mediate the relationship between CGM use and A1C among patients. 3.Identify factors that influence CGM uptake among healthcare providers, staff, and patients. Providers, staff, and patients will complete interviews about their experiences with CGM post-intervention. H3: NA. Research Design & Methods: The study aims will be achieved in a three-phase, three-year project. This study will be conducted in collaboration with Innercare, which is a federally-qualified health center in Imperial County, CA, and participants will include healthcare professionals (HCPsl including prescribing clinicians and their staff) and patients recruited from the three largest Innercare clinics in Imperial County: Brawley, El Centro, Calexico. In Phase 1, the investigators will evaluate a systems-level intervention (CGM prescription toolkit and associated training for HCPs and staff) designed to improve CGM prescription rates among patients with T2D in primary care clinics (Aim 1, 1a, 3). In Phase 2, the impact of CGM use on diabetes management among patients with T2D will be evaluated through an examination of A1C laboratory values extracted from the electronic health records (EHR) of patients who were prescribed and received a CGM during the study period (Aim 2). Additionally, the mechanisms of action for CGM will be explored by examining diabetes distress as a mediator between CGM use and A1C values among a subset of patients who complete a self-report survey that will be linked to their EHR data (Aim 2a). In Phase 3, patients will participate in one-on-one interviews about their experiences with CGM, including challenges and facilitators to accessing and using the technology (Aim 3).
Phase
N/ASpan
153 weeksSponsor
San Diego State UniversityRecruiting