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NCT04226027
In this project, the investigators will evaluate the efficacy of a novel approach to personalizing behavioral interventions for self-management of type 2 diabetes (T2DM) to individuals' behavioral and glycemic profiles discovered using computational learning and self-monitoring data. This study is a two-arm randomized controlled trial with n=280 participants recruited from the participating Federally Qualified Health Centers (FQHCs). The participants will be randomly assigned to the intervention group and the usual care (control) group with 1-1 allocation ratio. Half of the participants (n=140) will be randomly assigned to a usual care (control) group. Both groups will receive standard diabetes education at their respective FQHC site. In addition, the experimental group will receive instructions to use T2.coach for a minimum of 6 months.
NCT07579702
This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.
NCT07187830
Obesity is considered a global pandemic and is associated with various diseases and metabolic complications, such as type 2 diabetes mellitus, high blood pressure, cholesterol disorders, cancer, cardiovascular disease, and kidney disease. Obesity can affect the kidneys in two main ways: indirectly, through mechanisms related to diabetes mellitus and/or high blood pressure, and directly, through complex proteins called "adipokines," which are produced by adipocytes. Many of these adipokines are secreted by adipocytes under normal conditions, as they contribute to maintaining immune defenses and energy production. However, in obesity these adipokines acquire harmful properties and produce chronic inflammation in vital organs, such as the heart, blood vessels, the pancreas, and the kidney, leading to a deterioration in liver and kidney function. New drugs such as glucagon-like peptide-1 receptor agonists (GLP-1Ras / Semaglutide), are not only effective to regulate blood sugar levels, but they produce weight loss improving kidney and liver function. However, little is known about their specific effect on the adipose tissue. Therefore, studies focusing on how these drugs work in fat could help us understand how diseased adipose tissue can affect patients with heart, liver, and kidney disease. Investigators are asking patients who attend the diabetes clinics associated with the University of Alberta to join the study.
NCT07234864
A Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of ZE63-0302 administrated orally in T2DM patients.
NCT05046886
In a randomized trial of 255 participants with early-stage T2D, participants will be randomized to 1 of 3 groups: Standardized, Personalized, or a Usual Care Control (UCC). In the first phase, participants will be randomized with equal allocation to these 3 groups. In the second phase (current phase), the remaining participants will be randomized with equal allocation to the Standardized and UCC groups.
NCT06613854
The goal of this clinical trial is to learn if early combination with two antidiabetic drugs further improves blood glucose control compared to a single drug regimen in adults with short duration of type 2 diabetes. It will also learn about the effect of the combination treatment on body weight, body composition, blood lipids, oxidative stress, inflammation, metabolic control, insulin resistance and insulin secretion from pancreas, together with its safety profile. The main questions it aims to answer are: * Does early combination with two antidiabetic drugs improve blood glucose levels, determined by continuous glucose monitoring system? * Is early combination treatment as safe as treatment with a single antidiabetic drug? * Does early combination treatment reduces the need for rescue therapy? * Does early combination treatment reduces body weight and improves body composition? * Does early combination treatment improves blood lipid parameters, oxidative stress and inflammation? * Does early combination treatment improves metabolic parameters? * Does early combination treatment improves insulin resistance and insulin secretion? Researchers will compare early combination treatment with metformin and either peroral semaglutide or empagliflozin to a single drug regimen with only metformin to see if the combination treatment works to treat type 2 diabetes. Participants will: * Take the combination of two antidiabetic drugs or only metformin for every day for 26 weeks. * Visit the clinic four times during the study duration for checkups and tests. * Carry a continuous glucose monitoring sensor for 14 days prior to study visits.
NCT06993064
Type 2 Diabetes Mellitus (T2DM) is a very common disease in Mexico, and its long-term complications affect years of healthy life and a high cost in treatmenty. T2DM is a chronic disease associated to inflammation. We aim to establish if Vitamin D may help decrease this inflammation and improve the condition in adults with T2DM. Patients included in the study will have to take 1 pill/day of vitamin D for six months. The investigators will measure weight, height, waist and hip circumference, systolic and dyastolic blood pressure; obtain dietary and clinical information, as well as a 10mL blood sample from the arm, for laboratory analyses, finger-prick blood sample for glucose at the beginning and end of the study; ´plus a finger-prick blood samplo for the initial vitamin D status. The study is completely free for the participants and they may withdraw their consent at any time without any consequences. Participants will have to attend the clinic at the beginning and every two months until the end, to receive their supplement (total 4 appointments). They will receive a phone call once a week to remind you to take your pills. They will be handed your results at the end of the study.
NCT07487103
This study is to evaluate the efficacy and safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes. The primary objective is to demonstrate equivalence of QLG1091 and Rybelsus. This study is a randomized, open-label, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 33 weeks including screening and follow-up.
NCT06376240
Patients with type 2 diabetes have an increased risk of developing vascular complications. Microvascular dysfunction might be caused by the increased production of methylglyoxal under hyperglycaemic conditions. Methylglyoxal is a by-product of glycolysis and forms advanced glycation endproducts (AGEs) on proteins and DNA, thereby disrupting their function. Preventing methylglyoxal accumulation and AGEs formation may offer a therapeutic option for treating microvascular complications in diabetics. Pyridoxamine is a vitamin B6 vitamer that scavenges methylglyoxal and thereby inhibits the formation of AGEs. In this study, the researchers investigate whether pyridoxamine supplementation in type 2 diabetes improves microvascular function in the eye, kidney and skin, and reduces markers of endothelial dysfunction and glycation.
NCT05734989
In Aim 1 of this study, the investigators will utilize community organizations to screen Hispanics/Latino(a)s for kidney disease, diabetes, and other risk factors, and refer them for care with a PCP. In Aim 2, the investigators will implement an intervention in local health clinics to assist PCPs with screening and treating Hispanic and Black patients with diabetes. Completion of the project will hopefully slow progression of kidney disease among Hispanic/Latino(a) and Black patients in Durham, and the information gained will allow the investigators to eventually perform the intervention on a larger scale.
NCT01283113
The main aim of this study is to compare 2 different measurements of visceral fat that can be easily used in clinical practice (waist circumference versus bioelectric impedance) in relation to known risk factors of coronary artery disease in a large cohort of patients with type 2 diabetes and with a BMI range between 20-45 kg/m2
NCT07537088
The purpose of this study is to evaluate whether adding dulaglutide to the combination therapy of Sodium-Glucose Co-Transporter 2 Inhibitors(SGLT2i) and finerenone can provide additional kidney protection and safety for Chinese adults with Type 2 Diabetes Mellitus(T2DM) and Chronic Kidney Disease(CKD). Eligible participants will be adults with T2DM and mild-to-moderate CKD who have been receiving SGLT2 inhibitor plus finerenone for at least 3 months on the basis of maximum tolerated dose of renin-angiotensin system inhibitor (RASi). Participants will be randomly assigned to either continue the original regimen or to receive add-on therapy with dulaglutide.The study will last for 26 weeks, with participants required to attend scheduled visits for efficacy and safety assessments at Week 13 (±1 week) and Week 26 (±1 week, final visit).
NCT07542834
As the U.S. population ages, future physicians must be prepared to care for older adults with multiple health conditions and complex needs. This study will test whether cinematic virtual reality (VR)-an immersive, interactive learning tool-is more effective than traditional lectures in helping medical students learn about geriatric care. Students who complete the VR training will experience realistic patient scenarios that show what can go wrong in medical care and learn how to apply osteopathic principles to improve outcomes. Researchers will compare students' performance on a clinical skills assessment and explore their experiences with the VR training. The goal is to determine whether cinematic virtual reality can better prepare students for residency and improve their ability to provide compassionate, high-quality care for older adults.
NCT07272837
The aim of this study is to use advanced MRI scans to track changes in both muscle and fat in the body and heart over a 12-month period in individuals starting semaglutide. By doing so, we hope to gain a clearer understanding of how semaglutide affects muscle health and function. Our goal is to ensure the medication supports long-term well-being, particularly for people who may be at higher risk of muscle loss. This study involves (3) in-person study visits. At each visit, participants will be asked to: * Undergo magnetic resonance imaging (MRI) while resting and during exercise to take pictures of their heart, abdomen, and legs. * Complete tests to assess balance, sit-to-stand, walking speed, and handgrip strength. * Complete questionnaires related to demographics, health information, physical activity, and nutrition. * Have a blood sample collected from a vein in your arm. * Have your blood levels assessed through three finger pricks. * Complete three days of food records.
NCT07232537
This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone are collected and studied. Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and extra water from the blood. Type 2 diabetes occurs when the body does not produce enough insulin or does not use it effectively, leading to high blood sugar levels that can harm the kidneys. As a result, CKD can develop as a complication of T2D. The study drug, finerenone, is already approved for doctors to prescribe to patients with CKD and T2D. Finerenone is a medication that works by blocking certain proteins known as mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. The main purpose of this study is to learn more about characteristics and treatment patterns of people with CKD and T2D who have recently started or will start finerenone treatment as prescribed by their doctor as part of their routine medical care in South Korea. The FINE-REAL Korea study is designed to collect additional data on people with CKD and T2D who are treated with finerenone according to the approved product information, and it will work alongside the original FINE-REAL study (NCT05348733) to gather enough information for safety assessments in Korean population. To achieve this, researchers will collect data on: * Clinical characteristics of participants, including their medical history related to CKD and T2D, blood pressure, and heart health. * Reasons for starting finerenone. * Reasons for stopping finerenone early. * The planned and actual duration of finerenone treatment. * The dosing of finerenone. * Other medications taken alongside finerenone. The study will also monitor any medical problems (known as adverse events) that participants may experience during the study. All adverse events will be recorded, regardless of whether they are related to the treatment. One specific concern is hyperkalemia, which refers to high potassium levels in the blood. This condition can occur when finerenone is used with certain blood pressure medications. Researchers want to understand how often hyperkalemia happens and whether it leads to: * Early discontinuation of finerenone treatment. * The need for dialysis, a procedure that filters waste from the blood. * Hospitalization for care. Data for this study will be collected from medical records and through interviews conducted by study doctors during routine medical visits. Participants will be involved in the study for up to 12 months, although this duration may be shorter if their finerenone treatment is stopped early.
NCT07394075
The goal of this project is to see if an electronic health record (EHR)-based smart order set with continuous glucose monitoring data to provide decision support can improve blood sugar management in people with type 2 diabetes (T2D) using insulin.
NCT06815081
Type 1 diabetes (T1D) is a chronic condition, affecting 1 in 490 children under the age of 15 years. It is caused by the immune system damaging the pancreas, the organ which makes insulin. T1D has recognised stages before symptoms develop, providing an opportunity for early diagnosis, education and treatment which may delay the onset of symptoms. Type 2 diabetes (T2D) is also a chronic condition where the body cannot make enough insulin, or cannot respond to the insulin properly. It is usually related to obesity, rather than an immune problem. It is more common in adults, but the early stages often start in childhood (up to 1 in 4 children in some clinics). Like T1D, early detection can delay onset of T2D, or even prevent it altogether. Early diagnosis of T1D or T2D often relies on a test called the oral glucose tolerance test (OGTT), which is commonly used but not well tolerated, possibly because it requires a drip inserted into the vein, and several blood samples taken over 2-3 hours in a healthcare setting. Our study aims to test whether we can do an OGTT using a finger-prick to test glucose, at home. We call this the 'GTT@home'. The finger-prick creates a drop of blood, which is done before and two hours after drinking a sugary drink. We will also explore whether a continuous glucose monitor (CGM), which reads glucose levels through the skin could be an alternative. We plan to recruit 90 children and young people, across two groups to assess the GTT@home. To understand the experiences of those involved in monitoring, we will invite young people, parents and healthcare workers to take part in an interview, to understand the impact of testing to predict clinical T1D. Group 1 will assess the accuracy of measuring glucose from a finger-prick blood test when compared to a blood test from the vein. We will recruit individuals who are having an OGTT as part of a research study, for clinical care or if they have agreed to have an OGTT for this study. Those with T1D will be invited to wear a CGM to explore its use as an additional, practical alternative. Groups 2 and 3 will assess how well the GTT@home test works when done at home and how acceptable it is. This will only be offered to those known to be at risk of T1D. These studies will help us to understand if the GTT@home can be used in routine care.
NCT07509502
The goal of this pilot clinical trial is to examine how receipt of ingredients for a Mediterranean diet (with or without nutrition classes) impacts Type 2 Diabetes Mellitus risk factors among adults in the US South. The main question it aims to answer is: \- Will greater improvements in diet quality (HEI Score) and body weight be seen in the group that receives grocery delivery and nutrition classes (TK+FiM) compared to the group receiving grocery delivery only (FiM only)? Researchers will evaluate the changes in diet quality and body weight among participants in each group to see which group experiences greater improvements. Participants will: * be randomly assigned to either receive weekly grocery deliveries and attend weekly virtual nutrition classes for 4 weeks or receive weekly grocery deliveries only. * be asked to complete surveys/questionnaires at the baseline and 4-week timepoints in the study. * be asked to participate in a post-study focus group to talk about their experiences during the intervention.
NCT06608212
This is an observational study in which data from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are collected and studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. CKD is a long-term condition in which the kidneys' ability to work properly gradually decreases over time. It is common in people with Type 2 diabetes mellitus (T2D), a condition in which glucose levels rise in the blood. People who have T2D and CKD may also develop heart disease over time. The study drug, finerenone, is already approved for doctors to prescribe to people with CKD and T2D in the US. It blocks the activity of a protein involved in worsening kidney function. The participants in this study are allowed to take finerenone as part of their regular care from their doctors. The main purpose of the study is to learn about how safe finerenone is and how well it works in people with CKD and T2D in routine medical care. To do this, researchers will collect information about the time to first occurrence of any of the following heart-related problems for participants in the US who are taking finerenone and those who are not taking it: * Heart attacks * Hospitalization due to heart failure The data will come from the electronic healthcare records of people with CKD and T2D in the US who are allowed to take finerenone after July 2021. Researchers will track participants' data and will follow them until the occurrence of heart-related problems, the participant's data is no longer available, there is a change in the participant's treatment strategy, or the end of the study. In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
NCT07507305
Brief Summary: Many people with diabetes in Nigeria have trouble controlling their blood sugar. This can lead to serious health problems such as heart disease, kidney damage, eye problems, and nerve pain. Medicines alone are often not enough if patients do not take them correctly, understand how to use them, or make healthy lifestyle changes. This study looks at whether extra support from a pharmacist can help patients with type 2 diabetes mellitus get better health results. The study is being done at Yobe State University Teaching Hospital in Nigeria. What the study is about: The investigators want to find out if a special "pharmaceutical care" program run by a pharmacist can improve participants' blood sugar control and overall health compared to the usual care they receive in the hospital. What participants will do: Participants who agree to join the study will be divided into two groups by chance. One group will receive the normal diabetes care from doctors and nurses. The other group will receive normal care plus regular meetings with a trained pharmacist. In the pharmacist sessions, participants will get: Clear explanations about their diabetes medicines (why they are needed, how and when to take them, and possible side effects). Help to solve any problems with taking medicines correctly. Simple advice on healthy eating, physical activity, and checking blood sugar at home. Regular follow-up to answer questions and check progress. No new or experimental drugs are being tested. No injections, surgeries, or invasive procedures are involved. Patients continue with their usual diabetes medicines prescribed by their doctors. Why this matters: If the pharmacist support helps patients control their blood sugar better and feel healthier, it could be a simple and useful way to improve diabetes care in hospitals like ours. Better control can reduce the risk of serious complications and improve quality of life for patients and their families. The study will measure changes in blood sugar levels (HbA1c), blood pressure, how well patients take their medicines, and how they feel about their health. Investigators will compare the two groups after several months. This research does not involve any risk beyond the usual care patients already receive. Participation is voluntary, and patients can leave the study at any time without affecting their normal treatment.