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454 active trials for Diabetes Mellitus - Type 2

The Effect of 360 Video and MAPS on Enrollment in the DPP

We will conduct a three-armed randomized, clinical trial to test the incremental effectiveness of Mobile 360° Video and Motivation and Problem Solving in motivating individuals with Prediabetes to enroll in the Diabetes Prevention Program. all participants will receive notification that they have Prediabetes and education about Prediabetes, Type 2 diabetes, and the Diabetes Prevention Program, some participants will receive the additional interventions

Start: February 2021

Effect of Empagliflozin on Ventricular Repolarization.

The present project aims to investigate if the empagliflozin has an antiarrhythmic action. Analyzing the T-wave heterogeneity index, a new electrocardiographic risk marker associated with the prediction of cardiovascular risk, in diabetic patients and coronary artery disease, the investigators will verify if empagliflozin is associated with a reduction in electrical instability.

Start: October 2019

Cooking for Health

Type 2 diabetes is a leading cause of morbidity and mortality among American Indians (AIs) in the United States. Although healthy diet is a key component of diabetes management programs, many AIs face barriers to adopting a healthy diet including: difficulty budgeting for food on low-incomes, low literacy and numeracy when purchasing food, and limited cooking skills. The proposed project will evaluate a culturally-targeted healthy foods budgeting, purchasing, and cooking skills intervention aimed at improving the cardio-metabolic health of AIs with type 2 diabetes who live in rural areas.

Start: February 2020

Online Diabetes Education Project (ODEP)

This pilot randomized control trial will be testing an empowerment-based virtual group diabetes self-management education and support (DSME/S) for African American/Black adults with type 2 diabetes living in Detroit. Participants will be randomized to either a control group or the virtual DSME/S group.

Start: May 2021

Glycemic Targets for Pregnant Women With GDM and T2DM

The purpose of this randomized clinical trial is to determine whether glycemic targets that are lower than those currently recommended by the American Diabetes Association (ADA) and the American College of Obstetricians and Gynecologists (ACOG) would improve overall outcomes in pregnant patients with diabetes. Eligible pregnant women with a diagnosis of gestational diabetes or Type 2 diabetes will be randomized into either routine care with glycemic targets as currently recommended by ADA and ACOG (control arm), or more aggressive care with lower glycemic targets that more closely resemble normoglycemia in pregnancy (intervention arm). The glycemic targets for the control arm will be defined as follows: fasting ?95 mg/dL, pre-prandial ?95 mg/dL, and 1-hour postprandial ?140 mg/dL. The glycemic targets for the intervention arm will be defined as follows: fasting ?80 mg/dL, pre-prandial ?80 mg/dL, and 1-hour postprandial ?110 mg/dL. The primary outcome will be a 250-gram difference in birth weight between the two study arms. Secondary maternal and neonatal outcomes of interest will also be compared between the two study arms.

Start: June 2021

Social Support Intervention for Self-management of Type 2 Diabetes Mellitus

This study will assess the effect of a social support intervention for self-management of type 2 diabetes mellitus (DM2) in adults. This intervention is based on a medium-range nursing theory of individual and family self-management. Findings will be evaluated using the nursing outcomes "self-management: diabetes" and "social support" from the Nursing Outcomes Classification (NOC).

Start: July 2021

Michigan Men's Diabetes Project

The investigators propose to develop a training for male peer leaders facilitating diabetes self-management education and support (DSMES) to specifically encourage conversations regarding beliefs that affect men's health and to allow modeling of alternative views and perspectives that allow for successful disease management to be framed as competence and strength. Given that the life expectancy for Black men in the US is 71, the investigators hypothesize that targeting men in earlier stages of type 2 diabetes will assist greatly in facilitating healthy aging and improving diabetes-related health outcomes later in life. Based on the investigators previous work, the long-term goal of our research is to determine the most effective, practical, and sustainable approach to provide DSMES to older Black men. The objective is to examine the relative effectiveness, feasibility, and acceptability of a peer-leader DSMES intervention for Black men with T2D. To accomplish this, the investigators will engage in a developmental phase and a validation phase [pilot randomized control trial (RCT)]. The RCT will be conducted with 60 Black adult male residents of metro Detroit, MI. Participants will be randomized to a control group or the tailored peer-leader diabetes self-management support group (PLDSMS). All participants will receive DSME with a certified diabetes care and education specialists. Only participants randomized to the PLDSMS group will also receive an additional 6 weeks of DSMS led by the peer leaders. The investigators hypothesize that 1) participants in the PLDSMS group will have improved outcomes (A1c, blood pressure, weight, diabetes distress, self-management behaviors, etc.) over the control group, and 2) an evaluation of measures will confirm efficacy of the PLDSMS.

Start: May 2021

Remote Study Collecting Blood Glucose Values and Activity Data in Patients With Type 2 Diabetes on Different Treatments

The purpose of this study is to collect blood glucose values and activity data in patients with type 2 diabetes for approximately 12 weeks using electronic devices in a full virtual clinical setting. Virtual clinical setting means that all data are collected by use of participants' personal smartphone and study-related apps. In other words, everything will be handled without any visits to a hospital or doctor. For collection of participants' blood glucose values participants will receive two different blood glucose monitors. One where participants cannot see the blood glucose values and one where participants can see the blood glucose values. Participants must wear them consecutively for 2 and 10 weeks, respectively. Further, participants will be asked to self-apply the monitors on their upper arm. For collection of participants' activity data participants will receive an activity tracker, which participants will wear on the wrist throughout the study. We will ask participants to keep an electronic diary of the timing of the meal- and medication intake through two shorter periods of the study. On a voluntary basis, participants can choose to donate a saliva sample for the purpose of genetic research in diabetes patients. The study does not include any study medication and participants will continue the current antidiabetic treatment as prescribed to participants by their own physician. If any questions about the treatment and/or health condition while participating in the trial, participants should consult your own physician If participants are in doubt about what the blood glucose values mean or whether participants should react to the blood glucose values, participants need to contact the research staff or their general practitioner.

Start: May 2021

Mobile Health to Enhance Exercise in Type 2 Diabetes

Being physically active and exercising is important for the treatment of Type 2 diabetes as it helps control blood sugar and improve physical function. Lots of people find it hard to be physically active and sticking with exercise is difficult for most people. In this project we will investigate two strategies to support people with Type 2 diabetes to increase and then maintain a physically active lifestyle, which includes exercising regularly. Participants in one group (Exercise Counselling) will complete a 6-month structured exercise and physical activity programme supported by regular (virtual) contact with an exercise specialist. Participants in the second group (Mobile health technology (mHealth)) will receive the same 6-month exercise and physical activity programme supported by an exercise specialist, but participants in this group will also receive a fitness watch that links to a mobile phone application (App). The fitness watch and mobile App will allow the exercise specialist to provide greater support and feedback throughout the programme.

Start: February 2021

Educational Intervention to Increase Select Guideline-recommended Cardioprotective Medications in Patients With Diabetes

This is an educational outreach to patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) and their primary care and specialist providers to improve use of guideline-recommended treatments, specifically sodium-glucose cotransporter 2 inhibitor (SGLT2i) and glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications.

Start: July 2021

Impact of a Regional Program Agir Sur Sa SantE

The prevention and control of lifestyle-related non-communicable chronic diseases, including diabetes, obesity and cardiovascular disorders, that share common risk factors, has now become a major focus of the World Health Organization. Lifestyle modification, like improvement of diet, physical activity and tobacco cessation, is the corner stone of diabetes and cardio-metabolic chronic diseases (CMCD) prevention and management. Under the leadership of decision-makers of our regional health Agency in order to improve accessibility and quality of care, our team has collaborated to the development and implementation of an integrated care framework for the prevention and management of cardio-metabolic chronic diseases in primary care. This new care framework is currently being implemented in the context of community health centers (fall 2014) and family medicine groups (spring 2015), with the support of a Quebec Ministry of Health grant. The current research proposal aims to evaluate the implementation of this new care framework and explore its impact in the primary care context. This project is very important as it will generate knowledge on new models of care integrating preventive and management interventions in primary care settings, in continuum with specialized health care services and their implementation in an entire region.

Start: March 2015

Transform Type 2: Examining Meal-Delivery and Education for Diabetes Self-Care

The purpose of this research is to understand the impact of medically tailored meals on health-related biometrics (e.g., glucose time-in-range, waist-hip ratio, cholesterol) and how providing medically tailored meals promotes engagement in diabetes education and drives information-seeking behavior.

Start: May 2021

Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus

Recent studies have shown that withdrawing aspirin and maintaining P2Y12 inhibitor monotherapy for up to 12 months post-PCI, after a brief period of DAPT, reduces bleeding without increasing ischemic harm. Such effects have shown to of particular benefit in patients with diabetes mellitus (DM). However, if an aspirin-free approach can be considered after this time frame is a matter of debate. The aim of this study is to assess the PD effects of ticagrelor 60 mg with and without aspirin therapy in CAD patients and to compare this with a standard DAPT regimen of aspirin plus clopidogrel.

Start: March 2021

Electronic Alerts for Heart Failure Prevention in Diabetes

Type 2 diabetes mellitus (T2DM) is an independent risk factor for heart failure (HF) and is associated with significant morbidity and mortality. Recent therapeutic advances in pharmacotherapies, such as sodium-glucose cotransporter-2 inhibitors (SGLT2i), have shown to be beneficial in preventing HF among patients with T2DM. However, despite widely available risk prediction and stratification tools and evidence-based practice guidelines, SGLT-2i medications are under-prescribed in the United States. The proposed study is a pragmatic, single-center, randomized trial to test the feasibility and effectiveness of a clinical decision support (CDS) tool to alert providers and improve HF risk stratification in patients with T2DM.

Start: March 2021

A Randomized Trial to Slow the Progression of Diabetes

The research objective of this one-year study is to test whether an evidence-based, low-cost mobile diabetes management package (DMP), with or without an incentive program grounded in economic theory (M-POWER Rewards), can effectively and cost-effectively improve health outcomes for adults with type 2 diabetes.

Start: October 2019

Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes

The study is intended to assess the effect on glycaemic control of AZD9567, as measured by the glucose AUC(0-4) versus baseline following a standardised mixed meal tolerance test (MMTT), compared to prednisolone in adults with type 2 diabetes mellitus (T2DM). The study will also evaluate the safety, tolerability, and pharmacokinetics (PK) of AZD9567.

Start: November 2020

Peers LEAD Plus Healthy Living With Diabetes (HLWD)

The specific goal of this project is to decrease diabetes-related morbidity among African Americans (AAs) in Milwaukee through the integration of Peers LEAD, a culturally-appropriate program to increase medication adherence into Healthy Living with Diabetes (HLWD), an existing diabetes self-management program.

Start: April 2021

Phenotypes and Outcomes of Heart Failure With Preserved Ejection Fraction in Patients With Hypertension and Diabetes

Our study is the first multicenter study in Vietnam on clinical phenotypes of heart failure with preserved ejection fraction (HFpEF) in patients with concurrent type 2 diabetes (T2DM) and hypertension (HTN). The purpose of this study is to identify different phenotypes of the Vietnamese HFpEF-HTN-T2DM population, as well as the association of these phenotypes with long-term outcomes.

Start: April 2021

STUDY OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT AND PARTICIPANTS WITHOUT RENAL IMPAIRMENT

This study will characterize the effect of varying degrees of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF- 06882961 compared with participants with normal renal function.

Start: January 2021

Pilot RCT Feasibility Study: Cancer and T2D

The purpose of this study is to test a nurse-led intervention for adults with newly diagnosed cancer and undiagnosed/newly diagnosed Type-2 diabetes

Start: April 2021