View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:Introduction: Type 1 diabetes is a chronic autoimmune disease with multifactorial etiology, resulting in partial or complete destruction of pancreatic β cells, leading to an absolute deficit of insulin and vital dependence on exogenous insulin. Treatment for type 1 diabetes (T1D) involves externally replacing the functions of pancreatic β cells through the administration of external insulin, aiming to achieve blood glucose levels close to normal ranges. Among the factors influencing postprandial glycemic excursions is the glycemic index (GI), defined as the potential of a food's carbohydrates to raise blood glucose. Many studies to date conclude that foods with a higher glycemic index (GI) result in a greater area under the curve in postprandial glycemia. Studies in children and adults with diabetes have reported that individuals with higher non-nutritive sweetener (NNS) consumption do not exceed the acceptable daily intake (ADI) limit in most cases. Regarding the effect of non-caloric sweetener consumption on appetite-satiety and postprandial glycemia in T1D patients, there is no available evidence. General Objective: To compare the effect of consuming a breakfast with and without sweeteners on postprandial glycemic response and appetite-satiety sensation in subjects with type 1 diabetes. Methodology: A prospective experimental study will be conducted with non-probabilistic convenience sampling over 2 months. Thirty-two adult volunteers with T1D using intensified insulin analog schemes or insulin pumps will be recruited. Nutritional assessment and a dietary survey will be conducted to determine the habitual consumption of non-nutritive sweeteners. Two breakfasts will be tested, one with and one without non-nutritive sweeteners (separated by 7 days). Additionally, a test with White Bread (as a standard food) will be conducted. Both the standard food and the breakfast will provide 50 g of available carbohydrates in each session. Subjects will administer rapid-acting insulin before ingestion according to their ratio and sensitivity. The glycemic index of each breakfast will be determined, and the glycemic response will be analyzed using capillary glucometry and continuous glucose monitoring, with each subject serving as their own control. Finally, appetite-satiety will be determined using a visual analog scale. One-way ANOVA and the t-student test will be used for statistical analysis. Statistical analysis will be performed using IBM SPSS Statistics v.22 (SPSS Inc., Chicago, Illinois). A p-value < 0.05 will be considered significant for each analysis. Expected Results: It is expected that the breakfast with non-nutritive sweeteners will induce a higher postprandial glycemic response, measured as a greater area under the curve in adult T1D subjects. Furthermore, it is anticipated that after consuming the breakfast with non-nutritive sweeteners, T1D subjects will experience increased appetite and reduced satiety.
FOOTSAK is a Footwear Self-Assessment Kit intended to empower people with diabetes by providing the necessary tools and instructional materials to enable self-assessment to determine whether footwear has adequate length and width. This feasibility study aims to determine whether people with diabetes and their footwear buddies can use FOOTSAK with sufficient (1) accuracy, (2) reliability and (3) ease of use to identify incorrectly fitting footwear (IFF). Ten people with type 1 or 2 diabetes without any minor or major toe or foot amputation will be recruited to use the FOOTSAK. Given that foot measurements have to be made whilst standing (to ensure full blood flow to feet during measurements), ten 'Footwear buddies' - will also be recruited. These are people with or without diabetes willing to measure the feet of participating people with diabetes (for example, a spouse, partner, carer, friend, neighbour, or housemate). Both participants are asked to watch instructional videos/short demonstrations and read large text instructions. Footwear buddies are asked to repeatedly measure the feet of people with diabetes. People with diabetes are asked to repeatedly measure their footwear then assess whether they are correctly fitting. The feet and footwear of participants with diabetes are then measured by a trained researcher to determine accuracy. 1. Determine whether foot measurements made by footwear buddies are accurate: +/- up to 5mm when compared to a trained researcher. 2. Determine whether repeated footwear and foot measurements made by participants are reliable: Intraclass Correlation Coefficient ≥0.83 for footwear length and ≥0.72 for footwear width (assuming a 15% decrease in reliability when compared to a trained researchers' scores). 3. Determine whether FOOTSAK measuring tools and instructional materials ease of use ≥7.0 /10.0 using Visual Analogue Score with free text comments. Any measuring tool failing to obtain a score of 7.0 or higher will be replaced in consultation with PPI participants and any instructional tool amended through PPI.
The trial is expected to enroll 120 confirmed cases of type 1 or type 2 diabetes. All eligible subjects must wear a continuous glucose monitoring system on both the left and right upper arms for a maximum of 15 days (360 hours) and adhere to the clinical visit protocol. The entire trial process consists of pre-screening visits, 5 clinical visits, and 1 telephone follow-up. After enrollment, all subjects will be randomly assigned to either Group A or Group B to determine the time points for clinical visits. Group A subjects will have venous blood drawn on days 1 and 10 (±1) post-wearing, while Group B subjects will have venous blood drawn on days 5 (±1) and 15 (-1) post-wearing. All subjects will remove all devices on day 15 (-1) based on system prompts and undergo a telephone follow-up on day 4 (±3) thereafter. This clinical trial does not involve long-term follow-up. During the trial, the blood glucose values measured by the "continuous glucose monitoring system" worn by the subjects will be analyzed against the EKF venous blood glucose values measured at the medical institution on days 1, 5 (±1), 10 (±1), and 15 (-1) as control reference values. This analysis aims to evaluate the accuracy, repeatability, stability, high and low blood glucose event alerts, and safety of the continuous glucose monitoring system. Additionally, fingertip blood glucose measurements taken by subjects during home use will be collected to assess the operational feasibility of the continuous glucose monitoring system in a home setting.
The American Society of Anesthesiologists (ASA) does not specify a fasting period for patients with certain comorbidities, such as diabetes, for elective surgery, and does not make a separate recommendation for surgery. The European Society of Anesthesiology (ESA) guidelines do not differentiate between diabetic patients and normal patients. Aspiration of gastric contents is a common cause of perioperative morbidity and mortality. Aspiration can cause hypoxia, bronchospasm, pneumonia, acute respiratory distress syndrome and death. The presence of food or fluid in the stomach before induction of anesthesia is one of the greatest risk factors for perioperative pulmonary aspiration. Sedation and general anesthesia suppress or inhibit physiologic mechanisms (tone of the lower esophageal sphincter and upper airway reflexes) that protect against aspiration. Because restriction of fluid and food intake before general anesthesia is vital for patient safety, Anesthesiology societies have developed guidelines for preoperative fasting. Current ASA guidelines recommend at least 2 hours fasting for clear liquids, 6 hours fasting after a light meal (toast and clear liquids) and 8 hours fasting after a high calorie or fat meal. The information obtained from gastric ultrasound allows anesthesiologists to determine the optimal timing of procedures, type of anesthesia and airway management technique.
With over 4 million people living with diabetes in France, i.e. 6% of the general population, it is necessary to consider both their physical and mental health. Indeed, recent studies have shown that with a good quality of life, patients have better disease management, improved physical health and social life, and reduced anxiety and depressive symptoms. Quality of life is at the heart of this research project. In order to improve it, several psychotherapies can be used, notably those that include mindfulness. Of all those proposed in the literature, Acceptance and Commitment Therapy (ACT), developed by Hayes, appears to be ideally suited to this objective. The aim of this psychotherapy is to improve the patient's psychological flexibility. According to the scientific literature, ACT therapy has been shown to improve the quality of life of patients living with diabetes, as well as their ability to manage their condition and reduce anxiety and depressive symptoms. This research project aims to: 1. To help patients cope better with their illness through learning the different dimensions of ACT therapy in order to obtain a toolbox to use on a daily basis, when necessary. 2. To offer professionals alternatives to the traditional care of diabetic patients with the toolbox cited above. 3. To enable health authorities to take advantage of this program and these different exercises to reduce complications in the medium and long term for people with diabetes and change health behaviors. In 2020, the French Diabetics Federation created the "Slow Diabetes" movement. The initial objective of which was to help people with diabetes to better cope with their isolation linked to the Covid-19 pandemic. Since its launch, this movement has taken the form of several programs lasting three or six weeks and developed to improve the general well-being of people with diabetes. The research proposed here seeks to improve the quality of life of diabetic patients through online ACT therapy, based on the "Slow Diabetes" model.
Insulin-treated diabetes in dependent or institutionalized patients is often poorly balanced and continuous glucose measurement is underused. The purpose of this tudy is to know how smart connected insulin pens and continuous glucose measurement can improve insulin therapy practice in dependent and/or institutionalized patients?
This project will use a mixed design and will be conducted at the West Parry Sound Health Centre. Based on similar studies there is an expected 10% drop-out rate so 20 participants per group will be invited to aim to have 15 finish. Total participants invited over the two-year study will be 40. The participants will be followed over a Complete 6-month Lifestyle medicine Intervention Program (CLIP) involving a collaboration between physicians, health coach, registered dietitians, and kinesiology. The CLIP will cover the 6 pillars of lifestyle medicine in 12-14 fundamentals of lifestyle medicine group classes.
Type and Aim of Research This research will be conducted as a randomised controlled experimental study design to test the effect of web-based diabetes education on the quality of life and self-care activities of individuals with Type 2 Diabetes. Place and Time of the Study This research will be conducted between September 2023 and March 2024 with individuals registered to the Cyprus Turkish Diabetes Association. Population and Sample of the Study The population of the study consisted of individuals with Type-2 diabetes who applied to the Cyprus Turkish Diabetes Centre. The sample of the study included individuals with type-2 diabetes who met the inclusion criteria at the Turkish Cypriot Diabetes Centre. Sample size was calculated using G Power statistical programme (n=74). In order to evaluate the effectiveness in the experimental and control groups, simple randomisation was performed to ensure the similarity of the two groups. Randomisation was applied after the pre-tests. The data of the study will be collected by Sociodemographic Data Form, Diabetes Specific Quality of Life Scale, Diabetes Self-Care Activities Questionnaire, Website Analysis and Measurement Inventory. The forms will be applied to the participants face to face. People in the experimental group, whose information was sent to the researcher, will receive reminder messages twice a week (Wednesday-Friday) during the 3-month follow-up period via the website. No intervention will be applied to the control group. The post-test will be applied.
The goal of this clinical trial is to learn about inour study aimed to evaluate serum lipid profiles of T2DM patients before and after Chiglitazar Sodium administration. The main question[s] it aims to answer are: - Quantitative lipidomics information enables in-depth analysis of lipids and can reveal Chiglitazar Sodium-specific lipid metabolic patterns, thereby strengthening lipidomics as a promising tool for exploring the molecular mechanisms of T2DM. - It can also be applied to other T2DM lipidomics studies to better understand lipid metabolism patterns and integration with other omics measures.
Observation study, shows the relation between diabetes, its neurological and optical complication and hearing loss, by asking participants questions about there age,BMI,job,the history of any cataract,diabetes retinopathy or heart attack,hypertension,swollen or tingling legs and take there consent to measure the hearing impairment.