View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:The investigators have previously studied a group of young children with T1D using brain MRI, age-appropriate neurocognitive testing and continuous glucose monitoring, followed for 18 months. The investigators observed significant differences in gray matter volumes and white matter microstructure in the children with diabetes as compared to controls. These differences appeared to increase over time, with slower rates of brain growth in the T1D group (Mazelli, et al, Diabetes 2014; Barnea-Goraly, et al, Diabetes Care 2014; Mauras, et al, Diabetes 2015). In this new protocol the investigators will include the same children with T1D and healthy controls previously studied and recruit new similar subjects to replace those lost by attrition. The investigators will be using structural and functional brain MRI, neurocognitive testing and measures of glycemic control, to determine if changes in the brain persist or worsen over longitudinal follow up, and whether these changes are associated with measures of glycemic control and neurocognitive metrics as these children grow and progress through puberty.
Over the past two decades, type 2 diabetes mellitus (T2DM) has emerged from relative obscurity to become one of the most serious complications of obesity in Hispanic obese populations, especially among those with a family history of T2DM. Few therapies have demonstrated long term efficacy in combating obesity and risk of T2DM in youth. Given the emerging evidence that glutamine and leucine (building blocks of protein) may affect energy partition and thus diabetes risk, and that the relationship of glutamine and diabetic risk has been further evaluated in one adult observational cohort study but data on leucine are lacking, we plan to conduct a clinical trial to determine the efficacy of glutamine to reduce insulin resistance, a diabetes risk factor. The primary specific aim of the research plan is to conduct a randomized, double-blind, placebo controlled, clinical trial to test the efficacy of 6 months supplements of glutamine in reducing biomarkers for insulin resistance and weight gain among 56 obese Hispanic adolescents age 12-19 years with a BMI at or above the 95th percentile and a family history of T2DM. At the end of the grant period, we will have obtained preliminary data to plan pivotal clinical trials of glutamine coupled with or without lifestyle changes.
Older people with diabetes will be assigned to the 1-year lifestyle program or no lifestyle program while continuing usual treatment for diabetes. The lifestyle program will consist of teaching how to practice healthy diet and regular exercise at our facility and continued into the community and home. It is hoped that the results would provide convincing proof about the usefulness of lifestyle change in older patients with diabetes.
The overall objective of the current proposal is to strengthen the putative link between FFA induced insulin resistance and atherosclerotic vascular disease (ASVD). To this end, the investigators will test the following hypotheses: 1) that FFA induced activation of protein kinase C βII (PKC β II) and δ and other serine kinases such as IκB kinase (IKK) in human muscle is associated with a decrease in insulin stimulated tyrosine phosphorylation of the insulin receptor substrate-1 (IRS-1) and of IRS-1 associated phosphatidylinositol 3 (PI3) kinase; 2) that these changes precede the development of insulin resistance; 3) that the decrease in IκB-α results in activation of nuclear factor κB (NFκB) and the expression of adhesion molecules and cytokines; 4) that PKC and IKK are involved in producing insulin resistance and activation of the IκB/ NFκB pathway and lastly 5) that the same mechanisms operative in healthy volunteers are also operative in patients with T2DM.The investigators will test these hypotheses in normal (current) and diabetic volunteers (previously completed) . Euglycemic-hyperinsulinemic clamps will be performed with and without co-infusion of lipid plus heparin (to raise FFAs) and by obtaining serial muscle and fat biopsies and blood samples will be obtained for measurement of substrates, hormones, enzymes and metabolites.
This is a multi-center randomized controlled trial comparing the effectiveness of community health worker (CHW) vs. usual clinician support in helping chronically-ill patients with low socioeconomic status to improve their health outcomes.
Community health centers across the US are seeking to address the growing prevalence of diabetes in adults. The University of Chicago has partnered with the MidWest Clinicians' Network (MWCN) to conduct a research study to train community health center staff and providers to implement and sustain diabetes group visits, also referred to as shared medical appointments, at their health center. The study's aims are to: 1) Develop, conduct, and evaluate a training program for health center staff to implement a diabetes group visit intervention in their health center; 2) Assess the implementation of diabetes group visits in the community health center setting and determine the cost of implementation; 3) Assess the feasibility and cost of implementing a text-messaging intervention in addition to the implementation of diabetes group visits in the CHC setting at one health center and 4) Assess the impact of the diabetes group visits alone and diabetes group visits plus text-messaging on diabetes process measures, patient outcomes, and patient satisfaction compared to control patients from the same health center with six months of follow-up once the six-month group visit program ends.
The purpose of this study is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration.
The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection. This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus. This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.
A Relational Agent (RA) "virtual counselor" (VICKY: VIrtual Counselor for Knowing Your Family History) has been developed to collect family health history information for common health conditions including heart disease, stroke, diabetes, hypertension and various cancers. In this study, the investigators will conduct a randomized controlled trial (RCT) to compare the efficacy of using VICKY to the existing My Family Health Portrait (MFHP) tool for collecting family health history information among an underserved primary care patient population. The primary aims of the study are to 1) evaluate the efficacy of VICKY versus MFHP for collecting accurate family health histories and 2) determine whether accuracy varies as a function of health literacy. This project will obtain validation data on the efficacy of both VICKY and MFHP for collecting accurate family history data among an underserved patient population, in two languages (English and Spanish). The study will determine whether a virtual counselor can overcome many of the existing barriers to using traditional web-based family history tools.
The incidence of type 1 diabetes (T1D) in young children (age <5 years) is rising. The burden of responsibility for disease management rests on parents and caregivers to check blood sugar, administer insulin, and monitor diet and physical activity to maintain tight glycemic control. This occurs at a vulnerable time in life when children's behavior is unpredictable, their T1D is difficult to control, and parenting stress is elevated. Despite behavioral interventions that have demonstrated success in reducing rates of parent stress and improving child behavior, improvements in young children's glycemic control has not been sufficiently achieved. The investigators' research will attempt to achieve this goal through the development and pilot of an innovative behavioral intervention for T1D in parents of young children. The focus of the intervention is on improving young children's nutrition and physical activity through the use of parent consultants and delivery of intervention through phone and text messaging. The study will be conducted in two phases. In Phase 1, 10 primary caregivers of young children (<5 years) diagnosed with T1D for at least 6 months will receive the intervention and then be assessed at 3- and 6- months post baseline on indices of behavior and glycemic control (including continuous glucose monitoring). Participants will also complete in-depth surveys to provide qualitative as well as quantitative data. At the end of Phase 1, the data will be analyzed and used to develop the intervention further for Phase 2. During Phase 2, 60 participants and their children will be randomized to either the revised intervention (treatment) or usual care (control) condition. Intervention components include: T1D management support delivered by trained lay parent consultants, and T1D parenting strategies specific to improving eating and physical activity behaviors delivered by bachelor's level behavioral assistants via telephone and text messaging. Biomedical and psychosocial measurements (including HbA1c, physical activity, nutrition, mealtime behavior, parenting stress, quality of life) will occur at baseline and 3- and 6-months post baseline. The results of this work will ultimately lead to a program which can improve young children's T1D management and glycemic control that can be translated into a variety of clinical practice settings.