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303 active trials for Diabetes

Patient-Centred Innovations for Persons With Multimorbidity - Ontario

The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is to reorient the health care system from a single disease focus to a multimorbidity focus; centre on not only disease but also the patient in context; and realign the health care system from separate silos to coordinated collaborations in care. PACE in MM will propose multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be grounded in current realities (i.e. Chronic Care Models including Self-Management Programs), that are linked to Primary Care (PC) reform efforts. The study will build on this firm foundation, will design and test promising innovations and will achieve transformation by creating structures to sustain relationships among researchers, decision-makers, practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 4 other provinces: British Columbia (BC); Manitoba (MB); Nova Scotia (NS); and New Brunswick (NB). The Team's objectives are: 1) to identify factors responsible for success or failure of current CDPM programs linked to the PC reform, by conducting a realist synthesis of their quantitative and qualitative evaluations; 2) to transform consenting CDPM programs identified in Objective 1, by aligning them to promising interventions on patient-centred care for multimorbidity patients, and to test these new innovations' in at least two jurisdictions and compare among jurisdictions; and 3) to foster the scaling-up of innovations informed by Objective 1 and tested/proven in Objective 2, and to conduct research on different approaches to scaling-up. This registration for Clinical Trials only pertains to Objective 2 of the study.

Start: January 2016
Nepal Pioneer Worksite Intervention Study

The proposed project will develop, implement, and test methodology for the design of an acceptable, effective intervention for diabetes prevention in a real-world setting. By determining the effectiveness of the intervention, the study will serve to guide the translation of research into routine public health prevention programs and policy. And, the hands-on experience will directly support the development of expertise, tools and training to advance translational science as a discipline. The study aims to test the effectiveness of an environmental and individual level intervention to prevent diabetes at Dhulikhel Hospital-Kathmandu University Hospital (DH-KUH), Nepal. Specific aims are to measure: Effectiveness of a canteen intervention on a composite score based upon improvement in 3 cardio-metabolic risk factors (0-3) [HbA1c decrease ?0.5%; a systolic blood pressure decrease (SBP) ?5 mm Hg; and plasma triglycerides decrease ?10 mg/dl] Effectiveness of a behavioral intervention on a composite score based upon improvement in 3 cardio-metabolic risk factors (0-3) [HbA1c decrease ?0.5%; SBP decrease ?5 mm Hg; and plasma triglycerides decrease ?10 mg/dl] Effectiveness of a canteen intervention on change in HbA1C and healthy food intake after six months of the canteen only (CO) intervention compared to the change over six months during the control period. Effectiveness of a behavioral intervention on change in Hba1c and healthy food intake after six months of behavioral intervention plus the canteen (CB) intervention compared to the change over six months during CO. We will recruit 366 adult employees of DH-KUH. At baseline (T1), 6 months (T2), 12 months (T3) and 18 months (T4), we will administer a standard questionnaire to record relevant characteristics of the participants (age, sex, education, income, marital status, and family history of CVD, physical activity, smoking, alcohol intake and diet). We will abstract food consumption data from the administrative database in DH-KUH. Blood samples will be collected and analyzed for HbA1c, fasting glucose, and lipid profile (HDL, LDL, total cholesterol, triglycerides). We will measure height, weight, waist circumference, hip circumference, and blood pressure. After 6 months of control period, the participants will receive the canteen intervention: (a) form and train a canteen improvement team; (b) train canteen staff on healthy cooking; (c) add healthy food and remove unhealthy food; (d) information and communication of canteen changes to employees; (e) monitoring of the interventions. After six months of the canteen intervention, half of the participants will be randomized to receive the behavioral intervention. The behavior intervention will be a combination of intensive education sessions, group counselling, goal setting and monitoring based on the Diabetes Prevention Program (DPP). The primary analysis will use ?^2test use to compare (a) Proportion of individual with score ? 2 during CO intervention to the proportion of individual with score ? 2 during the control period; (b) Proportion of individual with score ? 2 during CB intervention to the proportion of individual with score ? 2 during CO intervention. We will conduct a logistic regression with the proportion of individual with score ? 2 as outcome and CO vs CB as exposure at T4. Secondary analysis will use paired t-test to compare (a) the change in healthy food intake and HbA1c during CO to the change in healthy food intake and HbA1C during the control period (b) the change in healthy food intake and HbA1C% during CB to the change in healthy food intake and HbA1C% during CO period. We will conduct linear regression with HbA1c% as the outcome and CO vs CB as the exposure variable at T4. Further analysis will adjust for confounding in time-varying variables and assess effect modification.

Start: November 2016
Veteran Support and Resources for Diabetes

Patients with diabetes are often challenged by the routine of managing their diabetes, and may experience both stress and medical problems. Diabetes-related medical problems and stress often happen together and affect peoples' ability to live a full, happy and healthy life. Because of this, programs that help with medical problems and stress by teaching ways to better manage diabetes and stress may improve the lives of those with diabetes. Many excellent programs are available in the VA and in the community that help persons with diabetes better manage their medical problems and stress, but often times Veterans have trouble finding these programs. The purpose of the study is to see if a telephone-based coaching program improves the physical and emotional health of Veterans with diabetes more than use of a directory of community and VA resources and no coaching. The Veterans who receive the directory of community and VA resources will be given this at the beginning of the study and will access resources as they see fit. Those in the coaching program will be coached by a Veteran with knowledge of diabetes, mental health and community resources who will help them connect to care in the VA and/or community depending on their preference. Examples of resources available in the VA and community include mental health care and programs to help with diet, exercise and learning about how to better manage diabetes. Veterans who are interested in participating and pass screening will be enrolled in the study for about 6 months. Each enrolled Veteran will have a 50% chance of being enrolled in the coaching group and a 50% chance of being enrolled in the directory group (like the flip of a coin). Both groups will be asked to complete several questionnaires about their health and well-being by telephone. This will occur at the beginning of the study and three and six months later. The questionnaires will take about an hour to complete each time.

Start: October 2019
Evaluation of Accuracy of Continuous Glucose Monitoring (CGM) in Patients With End Stage Renal Disease (ESRD) on Intermittent Hemodialysis (iHD).

Recent advances in continuous glucose monitors (CGMs) and availability of commercial CGM products to patients with type 1 and type 2 diabetes has made the use of CGM more widespread. CGMs work by placing a probe underneath the skin of a patient, into the interstitial space. Patients with end stage renal disease (ESRD) who are on intermittent hemodialysis (iHD) or peritoneal dialysis (PD) undergo fluid shifts between the interstitial fluid and intravascular space during dialysis treatments.These fluid shifts, uremia, acidosis, and volume overload (increase in interstitial fluid volume due to ESRD) have the potential to impact the performance of the most advanced and commercially available CGMs; however, use of CGM in these patients has not yet been studied.Use of CGM, and potentially hybrid closed loop insulin delivery systems that are dependent on accurate continuous glucose monitoring, has the potential to improve glucose control and quality of life in these patients (7). This study team feels that this study will be valuable in collecting preliminary data needed with the goal of validating the use of CGM in this patient population. The specific aim is to conduct a pilot study to evaluate the accuracy of continuous glucose monitors (CGM) in End Stage Renal Disease (ESRD) patients on intermittent hemodialysis (iHD).

Start: February 2020
Does Insulin Requirement Post Cardiac Surgery Predicts The Risk Of Developing Diabetes

The patient outcome in cardiac surgery is substantially linked to the occurrence of hyperglycemia. Qatar ranks 5th in the rate of diabetes globally; Moreover diabetics comprise more than 40% of patients admitted to the cardiac surgery intensive care unit (CTICU) in Qatar heart hospital. This prevalence is higher than the rest of the world. These numbers are projected to increase with accompanied morbidity-mortality hazardous by 2030 if the adequate intervention will not be directed towards better control of blood sugar within ICU and the hospital stay. The overall objective of this project is to explore the immunological profile in patients with poor glycemic control within their intensive care unit stay in Qatar. 'time in range' (TIR) was used for defining glycemic control within the ICU, where patients with time in range more than 80%, (in presence or absence of debates), had better outcomes than those with time in range less than 80% TIR. Notably, regarding wound infection, lengths of ventilation and ICU stay; they were not candidates to recurrent hypoglycemic episodes also. The high HbA1C preoperatively is probably a valid forecaster of indigent glycemic control. Previous studies demonstrated conversion of non-diabetics to diabetics when they face stress of critical illness. No previous studies explored this possible conversion cardiac surgery. Our primary objectives will be to determine whether non-diabetic patients with poor glycemic control in cardiac surgery would develop subsequent diabetes later on. Investigators will follow up non-diabetics patients after 3 months to satisfy this aim. Investigators will include all patients who will undergo cardiac surgery over two years from the time of approval without evidence of diabetes as documented by glycated hemoglobin (HbA1C). Patients will be followed up to one year with laboratory investigations to document whether they will develop diabetes or not. Data will be stored and statistically analyzed. Investigators expect to have details about the possible conversion in this high-risk population.

Start: March 2021
Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)

Bariatric surgery procedures induce weight loss through restriction and/or malabsorption. The mechanisms underlying type 2 diabetes remission and others metabolic improvements after Roux-en-Y Gastric Bypass (RYGB), sleeve gastrectomy (SG) or biliopancreatic diversion with duodenal switch (BPD-DS) have not yet been formally studied. The investigators propose a longitudinal study with the overall objective of measuring the long-term impact of these three bariatric surgeries (RYGB, SG, BPD-DS) on metabolic, renal and cardiovascular fate in patients with type 2 diabetes. The investigators overall hypothesis is that some bariatric procedures generate hitherto unrecognized effects on many disease-related outcomes, which greatly contributes to their beneficial impact in diabetic patients. The investigators propose 3 specific aims: 1) to establish the long term effect of the three surgeries on the metabolic recovery and quality of life in groups of diabetic patients treated with insulin, hypoglycemic agents or diet; 2) to establish the long term impact of the three surgeries on renal and cardiovascular functions in subgroup of patients with these conditions; 3) to compare metabolic impact of surgeries to those of best medical care for diabetes in a non-surgical control group. For most severely obese patients, lifestyle interventions, perhaps effective in inducing short-lived weight losses, are ineffective for long-term weight loss maintenance and durable metabolic recovery. The increasing popularity of obesity surgeries calls for a better understanding of the underlying mechanisms. This is especially true and urgent when considering that knowledge on the relative impact of each procedure (i.e. SG vs. RYGB and BPD-DS) in resolving T2D is still limited. Better knowledge on each of the procedures will allow stronger scientific rationale for selecting the right surgery for the right patient and improve care for the severely obese individual.

Start: March 2015
Personalised Responses to Dietary Composition Trial

The foods we eat - our diet - can affect whether we develop diseases during our lives, such as diabetes or heart disease. This is because the amount and types of foods we eat can affect our weight, and because different foods are metabolised (processed) by the body in different ways. Scientists have also found that the bacteria in our guts (the gut microbiome) affects our metabolism, weight and health and that, together with a person's diet and metabolism, could be used to predict appetite and how meals affect levels of sugar (glucose) and fats (lipids) found in blood after eating. If blood sugar and fat are too high too often, there's a greater chance of developing diseases such as diabetes. The gut microbiome is different in different people. Only 10-20% of the types of bacteria found in our guts are found in everyone. This might mean that the best diet to prevent disease needs matching to a person's gut microbiome and it might be possible to find personalised foods or diets that will help reduce the chance of developing chronic disease as well as metabolic syndrome. The study investigators are recruiting volunteers aged 18 years or over from the TwinsUK cohort to take part in a study that aims to answer the questions above. The participants will need to come in for a clinical visit where they will give blood, stool, saliva and urine samples. The participants will also be given a standardised breakfast and lunch and fitted with a glucose monitor (Abbott Freestyle Libre-CE marked) to monitor their blood sugar levels. After the visit, the participants will be asked to eat standardised meals at home for breakfast for a further 12 days. Participants will also be required to prick their fingers at regular intervals to collect small amounts of blood, and to record constantly their appetite, food, physical activity and sleep using apps and wearable devices.

Start: June 2018
Prevention of Diabetes After Transplantation by Vildagliptin in the Early Post-transplant Period

Post-transplant diabetes affects 15 to 20% of renal transplant patients and contributes to increased morbidity and reduced survival of transplants and patients. Corticosteroids, anti-calcineurin and mammilian Target OF Rapamycin (mTOR) inhibitors have a major diabetogenic impact and greatly contribute to the increase in diabetes prevalence after transplantation. There are to date few studies concerning the pharmacological prevention of post-transplant diabetes. Hecking et al. have recently reported that a short treatment with insulin, administered immediately after transplantation, reduce the incidence of de novo diabetes one-year post-transplant. This study included 50 renal transplant patients and showed that a three months treatment of (Neutral Protamine Hagedorn) NPH insulin decreased HbA1c. The occurrence of diabetes, a secondary end-point, was reduced by 73% in the treated group. No further pharmacological strategy has been developed to date. Relevant experimental evidences suggest that gliptins could be used in the pharmacological prevention of post-transplant diabetes. These drugs are inhibitors of dipeptidyl peptidase-4 (DPP-4), which inactivates the incretins, the glucagon-like peptide-1 (GLP-1) and the gastric inhibitory polypeptide (GIP). DPP-4 inhibition causes an increase in the GLP-1 and GIP concentrations which induce insulin secretion and inhibition of glucagon secretion. The gliptins are approved for the treatment of type 2 diabetes. Beyond the effects on blood glucose, gliptins have pleiotropic effects including a protective effect on ? cells and anti-inflammatory effect. The additional cost associated with new-onset diabetes after transplantation could be also significantly reduced by efficient prevention. A US study found that, for the period between 1994 and 1998, a newly diagnosed diabetic patient has cost $21,500 of medical expenses 2 years after transplantation. Moreover, transplantation resulting in one of the best increases of patients' quality of life, its estimate is essential in the treatment evaluation of this population.

Start: October 2018