Active clinical trials for "Diabetes Mellitus"

The objective is to evaluate a culturally tailored adaptation of The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) protocol targeted for individuals with Type 2 diabetes mellitus (DM) living in the border areas of Ireland. The primary research question to be addressed is; what is the feasibility and acceptability of implementing a multicomponent intervention for the target population in a community setting in comparison to standard clinical care. The study protocol was informed by a phase 1 qualitative study (REC ref 19/NI/0011) involving the target population i.e. older people with Type 2 DM from the border areas of N Ireland and the Republic of Ireland and has been amended (version 2.0) in response to the coronavirus pandemic

The cornerstone in the initial treatment of type 2 diabetes (T2D) is lifestyle modification, involving-among other things-a healthy diet. However, scientific evidence regarding optimal nutrition therapy for patients with T2D is insufficient. This clinical study will examine the effect of a carbohydrate-reduced high-protein (CRHP) diet compared to a conventional diabetes (CD) diet for 12 months on metabolic function and body weight in patients with T2D. The hypothesis of the study is that the CRHP diet will improve metabolic control and the cardiovascular risk profile of patients with T2D to a greater extent than the CD diet. In particular, the expectation is that, compared with the CD diet, the CRHP diet will: Reduce diurnal and postprandial glycemia measured by continuous glucose monitoring (CGM) and thereby facilitate a significant reduction of glycated hemoglobin (HbA1c) Reduce body weight Reduce ectopic fat deposition in the liver and the pancreas Improve the blood lipid profile Reduce or not affect blood pressure with no adverse effect on heart rate variability Increase insulin sensitivity and secretion Decrease inflammatory markers in the blood Improve satiety Reduce or not affect the need for antidiabetic, antihypertensive and/or lipid-lowering medications

There has been a rise in type 2 diabetes (T2D) rates in adolescents, disproportionately in girls from disadvantaged racial/ethnic groups. This group of girls also is at heightened risk for depression, and depression and T2D are linked. Depressive symptoms are a risk factor for worsening of insulin sensitivity, one if the major precursors to T2D. In preliminary studies, the investigators found that a brief cognitive-behavioral therapy group decreased depressive symptoms and prevented worsening of insulin sensitivity in adolescent girls at-risk for T2D with moderate depressive symptoms. The aims of this study are: 1) to assess the efficacy of a cognitive-behavioral therapy depression group vs. a health education control group for improving insulin sensitivity and preserving insulin secretion in racially/ethnically diverse adolescent girls at-risk for T2D with moderate depressive symptoms over a 1-year follow-up; 2) to evaluate changes in eating, physical activity, and sleep as explanatory and 3) to test changes in cortisol factors as explanatory.

Pregnancy is a vulnerable period for both a mother and her developing child. The investigator hypothesizes that diet-induced glucose excursions in the pregnant mother are a key contributor to unfavourable brain development and epigenetic marks in the developing child. It is long known that metabolic conditions are influenced by maternal nutrition and that this can impact the unborn infant. The most prominent example is gestational diabetes (GDM). It is unclear at what point unfavourable changes in brain development occur during pregnancy. Unlike many previous trials, we plan to introduce healthy diet early in the first trimester. Comparative analyses of DNA methylation patterns in the offspring of women with or without GDM revealed preferentially methylated genes, particularly in pathways linked to metabolic diseases. NuPreGDM is a randomized, controlled, open label intervention trail. The investigator aims to assess the effect of individual diet counselling combined with CGM compared to regular diet on glucose levels and postprandial glycemic excursions during an OGTT in pregnancy. The investigator wants to assess the effect of dietary counselling combined with continuous glucose monitoring on GDM risk, glycaemia and pregnancy outcome, starting in the first trimester. The investigator further hypothesizes that improved glucose levels by a healthy diet will affect brain activity of the infant and prevent unfavourable epigenetic modifications. The investigator plans to include 50 pregnant women within gestational week 4 and 14 after the last menstruation, with elevated risk for development of (GDM). Participants will be randomized 1:1 to either "diet modification group" (intervention) or to "standard diet group" (control). In the current trial, the investigator aims to modulate maternal metabolism with periodic personalized diet counselling on the basis of continuous glucose monitoring (CGM) compared to regular diet throughout pregnancy. The investigator propose that a reduction in glucose excursions in the mother will lead to a healthy environment for the developing child and prevent altered brain activity in utero, which will be assessed by fMEG (fetal magnetoencephalography) during a 75g OGTT in gestational week 28. The investigator further planned to examine child's leucocytes from cord blood to assess whether a healthy diet of the mother prevented epigenetic alterations due to improved maternal glycaemia, as exploratory endpoint. The development of blood sugar levels of the mother postpartum will be assessed by an further OGTT 6-12 weeks postpartum.

This phase 2 study will include patients suffering from type 2 diabetes mellitus and will first study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. Participants with an incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily will be randomized to a random order of 3 different ASA regimens: EC ASA 162 mg once daily, EC ASA 81 mg twice daily and chewable ASA 40 mg twice daily. The aims are to determine the feasibility of a larger scale trial, and to determine the regimen associated with the lowest proportion of non-responders after randomization. Platelet function will be assessed at baseline and at day 7 of each arms of the study.

The study is being conducted to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with oral antidiabetic drugs compared to insulin Glargine QD for 26+26 weeks.

Investigator initiated, randomised, placebo-controlled, double-blind, multi-centre primary intervention study to assess whether daily administration of B. infantis EVC001 from age 7 days to 6 weeks (+14 days) until age 12 months (+ 14 days) to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood.

Diabetes is prevalent in adults admitted to subacute rehab (SAR) and long-term care (LTC) skilled nursing care facilities. Management of diabetes in these facilities is challenging due to number of older adults with higher prevalence of other diseases, functional disability, and altered nutritional intake, which increase the risk of hypoglycemia (low blood sugars). The investigators propose to conduct this randomized controlled trial to determine whether the use of Dexcom CGM with Glucose Telemetry System (CGM-GTS) with hypoglycemia alarm compared to standard of care using capillary POC testing, will facilitate diabetes treatment and reduce the risk of hypoglycemia in patients with T2D in LTC facilities. Participants in the standard of care group will also wear a CGM (blinded one). The results of this study have great potential to impact and facilitate care and to change current clinical guidelines in the management of older adults with diabetes in SAR and LTC facilities.

As more adolescents with type 1 diabetes (T1D) opt to follow very low carbohydrate diets to improve glucose control, it is becoming increasingly important to study the metabolic and neurological changes that occur on these diets and how these effect patient safety. Understanding the impact of dietary changes on metabolic and neurological factors will help guide clinical advice about the overall safety and efficacy of these diets in the pediatric T1D population. This work will be the basis of future studies testing dietary interventions to improve glycemic control and ensure that these dietary interventions are safe for growing youth with T1D.

A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System with Enhanced Features. The purpose of this clinical investigation is to evaluate the accuracy of the Eversense 524 Continuous Glucose Monitoring System (Eversense 524 CGM System) and ROME CGM System with next generation feature enhancements compared to reference glucose measurements in adults 18 years of age and older with diabetes. The investigation will also evaluate safety of the Eversense 524 CGM System and ROME CGM System usage. Additionally, the safety and accuracy of the Eversense 524 CGM System will be evaluated in the pediatric population ages 14-17 with Type 1 Diabetes Mellitus.