Active clinical trials for "Diabetes Mellitus, Type 1"

A Cluster-controlled Intervention Trial regarding Prevention of Dermatological Complications towards use of Continuous glucose monitoring and insulin pumps in pediatric patients with Type 1 Diabetes. The patients will be followed prospectively with visits every 3rd month for the first year of initiation of device. Besides a standardized treatment plan if dermatological complications evolve, will be used.

Type 1 diabetes mellitus (T1DM) is an immune-mediated disease characterized by diminished insulin secretion due to damage to islets of Langerhans in the pancreas, which eventually results in high levels of glucose in the blood. According to World Diabetes Foundation, in Palestine, 4.4% of diabetic patients are diagnosed with T1DM, while 95.3% are diagnosed with type 2 diabetes (T2DM) (World Diabetes Foundation, 2020). Observational studies have reliably provided evidence that T1DM patients with acceptable glycemic control have higher 25(OH)D levels than T1DM with lesser glycemic control. Additionally, it has been specified by some of the research-based studies that there is a strong connection between the deficiency of vitamin D and the incidence of T1DM. In interventional studies of T1DM children and adults, repletion of vitamin D in deficient individuals improved HbA1c in a period of 12 weeks. Participants were more likely to achieve HbA1c < 7.8% if they had higher 25(OH)D levels on week 12 than on baseline, especially if 25(OH)D levels were exceeded 51 nmol/l. According to the Food and Drug Administration (FDA), The Institute of Medicine's (IOM) recommended Upper Limit (UL) for chronic Vitamin D intake for infants (children less than 1 year of age) is 25 mcg/day (1,000 IU/d), and for children age 1 year and older the recommended UL is 50 mcg/day (2,000 IU/d) (Institute of Medicine Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, 1997). Despite a large amount of evidence from observational and experimental studies supporting the effects of vitamin D on glucose metabolism and the immune system, results from clinical studies remain inconsistent, which makes it impossible to recommend vitamin D supplementation for the treatment of T1DM. Therefore, this study aimed to investigate the status of vitamin D among T1DM children for vitamin and to examine the effects of vitamin D supplementation on glycemic control in children with T1DM. This is the first randomized controlled trial that studied the effects of vitamin D supplementation on glycemic control among T1DM children in the Gaza Strip, Palestine.

Empagliflozin, an inhibitor of the sodium glucose co-transporter 2 (SGLT2), reduces post-prandial glucose levels in adults with both type 2 and type 1 diabetes and importantly reduces both cardiovascular and renal complications in type 2 diabetes. In adults with type 1 diabetes empagliflozin improves endothelial function and vascular stiffness when used in conjunction with insulin. There is clear evidence that complications in type 1 diabetes have their origins during adolescents thus to reduce diabetic complications with adjunctive therapy, this age group must be studied. These studies will need to focus on the effects of these adjunctive agents on functional biomarkers for development of complications. This study is designed to develop pilot and feasibility data for a large scale trial of low dose empagliflozin, 2.5 mg daily, on biomarkers for the development of cardiovascular and renal complications in adolescents between 12 and 18 years of age. The investigators will specifically study the effects of 8 weeks of empagliflozin on: Pre-and post-prandial inflammatory markers using high carbohydrate and high fat meals. Inflammatory markers to be measured include interleukin-6 (IL-6), tissue necrosing factor α (TNF-α), complement component C3 concentrations and skin advanced glycosylation endproducts (AGE). Pre-and post-prandial vascular function including forearm vascular resistance, endothelial function and pulse wave velocity. Microalbuminuria and pre- and post-prandial glomerular hyperfiltration, tubular injury and renal inflammation. The investigators will, also, measure more traditional risk markers including blood pressure, hemoglobin A1c, and lipids. Eligible participants will have had diabetes for at least 1 year and not have other chronic medical illnesses or diabetes complications. Because of the risk of diabetic ketoacidosis (DKA) subjects must have a hemoglobin A1c level less than 9% and have no history of recurrent DKA or known insulin omission. This will be the first pilot study designed to explore primary endpoints regarding cardiovascular and renal disease rather than glucose control with empagliflozin therapy in adolescents with type 1 diabetes.

This single center case control study will assess differences in bone structure between women and men with longstanding type 1 diabetes (diabetes duration>/= 25 years) and healthy controls.

The study is a prospective, randomized, double-blind, placebo-controlled, multicenter trial in subjects with established T1D.

The study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial in subjects with new onset T1D.

Over 1.25 million Americans have type 1 diabetes (T1D), increasing risk for early death from cardiorenal disease. The strongest risk factor for cardiovascular disease (CVD) and mortality in T1D is diabetic kidney disease (DKD). Current treatments, such as control of hyperglycemia and hypertension, are beneficial, but only partially protect against DKD. Hyperfiltration is common in youth with T1D, and predicts progressive DKD. Hyperfiltration is also associated with early changes in intrarenal hemodynamic function, including increased renal plasma flow (RPF) and glomerular pressure. Intrarenal hemodynamic function is strongly influenced by the renin-angiotensin-aldosterone system (RAAS), which is also considered a key player in the pathogenesis of DKD. Preliminary data demonstrate differences in intrarenal hemodynamic function and RAAS activation in early and advanced DKD in T1D. However, the pathophysiology contributing to the differences observed in RAAS activation and intrarenal hemodynamic function in T1D are poorly defined Animal research demonstrates that arginine vasopressin (AVP) acts directly to modify intrarenal hemodynamic function, but also indirectly by activating RAAS. Preliminary data suggest that elevated copeptin, a marker of AVP, which predicts DKD in T1D adults, independently of other risk factors. However, no human studies to date have examined how copeptin relates to intrarenal hemodynamic function in early DKD in T1D. A better understanding of this relationship is critical to inform development of new therapies targeting the AVP system in T1D. Accordingly, in this study, the investigators propose to define the relationship between copeptin and intrarenal hemodynamics in early stages of DKD, by studying copeptin levels, renal plasma flow, and glomerular filtration in youth (n=50) aged 12-21 y with T1D duration < 10 y.

Over 300, 000 youth and young adults across Canada are living with Type 1 Diabetes (T1D) which is considered the most common endocrine condition. Physical activity offers numerous health benefits however the majority of persons living with T1D are physically inactive, primarily due to fear of low blood sugar (hypoglycemia). This fear of hypoglycemia continues to exist for physically active persons with T1D as no established physical activity guidelines exist. Several acute studies have used high intensity interval training as a way to reduce the risk of hypoglycemia as it has the ability to activate fight or flight hormones which can raise blood sugar; however the intensity needed to elicit this response is unknown. The purpose of this project is to determine the acute effects of varying exercise intensities on the time spent in a low blood sugar range in 10 sedentary (VIGOR acute sedentary) and 16 physically active (VIGOR acute trained) individuals with T1D. Each participant will complete a maximal exercise test prior to the exercise sessions. Sedentary participants will complete 45 minutes of continuous moderate intensity exercise at 45-55% heart rate reserve (HRR) and three high intensity interval sessions with six one minute burst of high intensity at 70%, 80%, or 90% of HRR every four minutes. Active participants will complete 45 minutes of moderate intensity exercise at 45-55% of HRR and one high intensity interval session at 90% of HRR with intervals spaced every two minutes. The investigators will track the blood sugar response to exercise using a device called a continuous glucose monitor (CGM) which records blood sugar every five minutes over a period of six days. The CGM will help determine which exercise intensity does a better job at reducing the time spent in a low blood sugar range. The information gained through this study will help individuals with T1D remain active without fear of low blood sugar and provide guidelines for professionals working with this population. Adding high intensity bursts at 80% and 90% of maximum aerobic capacity (active participants) or heart rate reserve (sedentary participants) to a moderate intensity exercise session will significantly reduce the amount of time spent in a low blood sugar range in sedentary and active persons with T1D compared to moderate intensity exercise alone.

This is the first prospective randomized double-blind placebo-controlled study to investigate the effect of a GLP-1 analog, specifically liraglutide, on blood glucose levels and variability in subjects with type 1 diabetes treated with insulin. Liraglutide is the preferred GLP-1 analog for this study because the pharmacokinetics and pharmacodynamics of the drug are consistent with a sustained duration of action. The current gold standard for management of type 1 diabetes is based on insulin replacement with novel analogs with specified pharmacodynamic profiles or with unique insulin delivery systems (insulin pump therapy). No other adjuvant therapy has demonstrated sustained benefit in this population. This study will also investigate the effect of liraglutide on suppression of glucagon secretion during meal challenges. This is of particular importance since, in the absence of insulin secretion from the β-cell, there is no paracrine inhibition of glucagon secretion by the α-cell. Dysregulation of glucagon secretion may impact the glycemic control and overall pathogenesis in those with type 1 diabetes. The use of CGM technology in this study will allow us to determine the rapidity, consistency, and sustainability of any response to liraglutide.

German Multi-centered, randomized, crossover study in diabetic patients evaluating two infusion sets under real life conditions at home. Subjects will be randomized to use one of the infusion set devices during the first period of 4 weeks, and be switched to the other infusion set for the second period of 4 weeks.