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309 active trials for Diabetes Mellitus

Identifying Therapeutic Targets of Accelerated Sarcopenia

The proposed research is designed to identify the mechanisms that can accelerate loss of muscle size, strength and physical function in type 2 diabetes and with hospitalization in older persons. About ? of older Americans have type 2 diabetes, and about ? of the hospitalizations in the USA involve persons older than 65 year of age. The proposed research is relevant to the part of NIH's mission that pertains to development of the fundamental knowledge that will improve health and reduce the burdens of disability, because this work will provide the fundamental evidence to identify new targets for the development of innovative treatments to slow down muscle loss and disability in our aging society.

Start: May 2017

The Influence of Malnutrition, Diabetes Mellitus, and Helminth Infections on Biosignatures in Latent Tuberculosis in a South Indian Population

About 2 billion people worldwide are infected with tuberculosis (TB). Ninety percent of those people have latent TB infection (LTBI). Risk factors like malnutrition, diabetes mellitus (DM), and helminth infection can affect the development of active TB. Researchers want to study LTBI individuals with these issues to see how they may contribute to a person s higher risk for developing active TB. This study will take place in Chennai, India. Objective: To estimate the prevalence of malnutrition, DM, and helminth infections in people with LTBI. Eligibility: People age 14 65 with or without LTBI. Design: Participants will be screened with a medical history and physical exam focused on symptoms of active TB. Those who have TB symptoms will not take part in the study. Those who do not have TB symptoms will have a physical exam with vital signs, height, and weight. They will give blood and stool samples. Participants will be assigned to 1 of 6 groups. They will repeat some of the screening tests. They will give urine samples. Some groups will have a chest X-ray. Some groups will have an ultrasound of the abdomen. Participants will complete a survey about their history of smoking and drug and alcohol use. Participants will have data collected about their nutritional status and body composition. Their skinfold thickness, ratio of waist/hip circumference, and grip strength will be measured. Participants with DM, malnutrition, or helminth infection will be given standard of care or referred for follow-up treatment. Participation will last up to 6 months.

Start: June 2021

ASCEND: ApproacheS to CHC ImplEmeNtation of SDH Data Collection and Action

This work will test a set of strategies for helping community health centers (CHCs) routinely identify and take action on the SDH-related needs of patients with / at risk for DM using a stakeholder-driven process to develop EHR-based SDH data collection / summary tools for CHCs.

Start: September 2018

A Transition of Care Model From Hospital to Community for Hispanic/Latino Adult Patients With Diabetes.

This pilot study was designed to address the existing gap in the transition of care of Hispanic/Latino Adults with diabetes from hospital to community. The over arching goal of this study is to develop, test, and determine the feasibility of a transition of care (TOC) model from the hospital to the community for adult Hispanic/Latino patients with diabetes.

Start: July 2021

Comorbidities And Reducing inEquitieS

Black cancer patients tend to have worse outcomes than White cancer patients. Some of this disparity may be due to comorbidities. The purpose of this study is to improve management of co-morbidities among cancer patients in order to improve cancer outcomes and improve health equity. Comorbidities such as diabetes and hypertension can complicate cancer treatment or can make it difficult to reach optimal health after treatment. This study will offer additional support and tools to manage cancer patient's health needs. First, the study will use a mobile health application, managed by a company called Welldoc, to monitor patient progress in real time and to provide ongoing guidance. Second, the study will connect patients with a Community Health Worker who will speak with them weekly to discuss self-care information, including medical scheduling or appointment needs, and assist with daily self-monitoring of blood pressure and/or blood glucose monitoring. Lastly, an oncology nurse will monitor reported health and triage any medical needs and whether additional medical care is needed.

Start: May 2021

A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.

Start: April 2021

Integrating Community Health Workers to Improve Diabetes Prevention

Cluster randomized trial to test the impact of peer health coaches on prediabetic patients. This study will test a scalable model of peer health coaching to address the millions of patients at risk for Diabetes Mellitus, using low cost, culturally congruent personnel to promote prevention of Diabetes Mellitus in patient-centered medical home (PCMH) practice.

Start: July 2017

The Effect of Family Support on Diabetes Patients' Health Beliefs, Behavioral and Metabolic Results

This study, designed according to the randomized pre-test and post-test control group experimental model, will be carried out with the patients who apply to the Diabetes Education Unit of Samsun Training and Research Hospital The universe of the study will consist of adult patients between the ages of 20-65 among the diabetic patients who apply to Samsun Training and Research Hospital Diabetes Education Unit. The sample of the study will consist of 100 diabetic patients who comply with the selection criteria and volunteer to participate in the study. The average scores of Hensarling's Diabetes Family Support Scale in Diabetes Patients were determined as 64.12, with an error margin of %5% and a 95% confidence interval, with a sample size of 80% with a sample size of 35 patients for each group, a total of 70 patients. Considering the participant losses during the project, 50 diabetic patients (experiment = 50, control = 50) for each group were determined as a total sample group of 100 diabetic patients with 50% reserve. Personal questionnaire prepared by the researcher in line with the literature, Health Belief Model Scale in Diabetes Patients, Hensarling's Diabetes Family Support Scale and Diabetes Attitude Scale will be used. The purpose of the study will be explained to the diabetic patients who apply to Samsun Training and Research Hospital Diabetes Education Unit and the study will be carried out with diabetic patients who agree to participate in the study. Diabetes patients will be divided into experimental and control groups by Simple Random Method. A training program will be applied to the diabetic patient and their family members included in the experimental group. After the training, a reminder text message will be sent to their phones twice a week for three months and they will be called once a month. Three months after the end of the training, the control will be called for examination.

Start: January 2021

Educational Interventions on Diabetic Foot Care

Diabetes mellitus currently affects 463 million people worldwide. One of the most serious complications of diabetes is the diabetic foot. Adequate foot care behaviours reduce the risk of ulcers, infections, and amputations, and improve the quality of life, in these patients. This Pragmatic Randomized Controlled Trial aims to analyse the impact of different educational strategies - an instructive video (Video Watching Group - Experimental Group 1) compared with a leaflet on foot care with real-time guided reading (Real-Time Leaflet Reading Group - Experimental Group 2) and with standard teaching on diabetic foot care (Standard Care - Control Group) - on adherence and knowledge regarding diabetic foot care, as well as on patient's perception of their foot health. Participants will be assessed at the first consultation of the diabetic foot (T0), about two weeks after the first assessment (T1), and three months after the T0 in a follow-up assessment (T2), with T1 and T2 being performed through telephone calls, after obtaining the patients' consent. The results of the present study will inform educational interventions regarding foot care adherence in patients with diabetic foot, in order to decrease the likelihood of developing diabetic foot ulcers and, consequently, to reduce amputation rates and the several associated costs, contributing to improving patients' quality of life.

Start: March 2021

Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes

This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis.

Start: July 2021

NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals

Black individuals are more likely to have decreased insulin sensitivity which results in a high risk for the development of cardiometabolic disease. The reasons for this are incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart that play a role in regulating the metabolic health of an individual. Low circulating level of NPs is an important contributor to increased risk for diabetes. The NP levels are relatively lower among Black individuals thus affecting their metabolic health and putting them at a higher risk for diabetes. This study aims to test the hypothesis that by augmenting NP levels using sacubitril/valsartan, among Black Individuals one can improve their metabolic health (as measured by insulin sensitivity & energy expenditure) and help establish the role of NPs in the underlying mechanism behind increased risk for cardiometabolic disease in these population.

Start: August 2020

Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD)

The purpose of this study is to test the hypothesis that allogeneic Mesenchymal Stem Cells (MSCs) promote systemic and coronary endothelial repair through rescue of bone marrow progenitors in type 2 diabetic patients with symptomatic IHD compared to placebo.

Start: October 2021

IDegLira HIGH Trial

Basal-bolus insulin therapy is recommended for patients with poorly controlled type 2 diabetes (T2D) and HbA1c >9%. However, basal-bolus insulin is labor intensive and associated with increased risk of hypoglycemia, glycemic variability, weight gain and poor compliance. Thus, there is a critical need for a simpler treatment regimen that could overcome these limitations. IDegLira, a fixed-ratio combination (FRC) therapy consisting of insulin degludec and liraglutide, is an attractive option for this population given its proven benefits on glycemic control, weight and compliance. This study aims to show that a simpler regimen using a novel FRC agent (IDegLira) can improve glycemic control, decrease hypoglycemia, reduce the burden of diabetes care, and improve satisfaction/adherence in patients with poorly controlled T2D with HbA1c between ? 9-12%. This open-label, treat-to- target, two-arm parallel, controlled trial will randomize participants with T2D and HbA1c ? 9%, treated with oral anti-diabetic agents and/or basal insulin therapy to lDegLira or basal-bolus insulin for 26 weeks.

Start: January 2019

Effects of a Patient Portal Intervention to Address Diabetes Care Gaps

The purpose of this study is to evaluate the effect of a novel patient portal intervention on the number of patients with diabetes care gaps (e.g., no diabetes eye exam i the last 12 months). The intervention is designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring & preventative care (e.g., annual urine microalbumin) are due and (b) allow patients to initiate orders for the care.

Start: October 2021

A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

This study is conducted to select the THR-149 dose level (Part A of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (Part B of the study).

Start: July 2020

Cardiac Arrhythmia in Patients With End-Stage Renal Disease

The study will examine the presence of cardiac arrhythmias in patients receiving hemodialysis and the role of diabetes, hypoglycemia and parameters related to uremia and the dialysis procedure. The study is designed as a prospective cohort study with 18 months follow-up. 70 patients receiving chronic hemodialysis will be recruited and equipped with implantable loop recorders (ILR): 35 patients with insulin-treated diabetes and 35 patients without diabetes. Data collection during the follow-up includes continuous monitoring of the heart rhythm by the ILR for the entire follow-up period, continuous glucose monitoring for 10 days every second month, and monthly collection of blood samples and dialytic parameters.

Start: May 2021

Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia

Researchers are trying to understand why people with indigestion and diabetes mellitus have gastrointestinal symptoms and in particular to understand whether symptoms are related to increased sensitivity to nutrients in the small intestine. As part of this investigation, a medication called ondansetron will also be studied to determine its effects on gastrointestinal function and associated symptoms.

Start: April 2019

Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases

There is limited knowledge about the extent of the impact of maternal metabolic diseases (MD) and/or alterations in maternal serum lipid content upon neonatal lipid distribution and phenotypes. This observational feasibility study aims to investigate the effect of maternal MD on fat distribution, lipid content and metabolic phenotype of different neonatal tissues. We will explore whether differences in tissue fat distribution and lipid content are observed in the neonates of women with MD during pregnancy, compared to those who have a healthy, uncomplicated pregnancy and if there are changes in how the different tissues work (e.g. cardiac function). If there is evidence to show that there are alterations during pregnancy in children of women with MD, this will help inform potential interventions to ensure optimal child health.

Start: June 2021

Evaluation a of Patient Portal Intervention to Address Diabetes Care Gaps

The purpose of this study is to evaluate the usability of a novel patient portal intervention designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring & preventative care (e.g., annual diabetes eye exam) become due and (b) allow patients to initiate orders for the care. In addition, the investigators will assess pre-post change on secondary psychosocial outcomes (e.g., self-efficacy).

Start: May 2021

American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)

Despite many advances in our understanding of the natural history and progression of chronic kidney disease (CKD) and cardio vascular disease (CVD) in the parent CRIC study over the past 15 years, important questions about key risk factors for these diseases remain unanswered in the AI population. To address this burden of CKD in AI communities Investigators formed a consortium of investigators with extensive experience in conducting research of chronic diseases including diabetes, cardiovascular and kidney disease in AIs of Southwestern US. The proposed CRIC ancillary cohort study of 500 AIs (AI-CRIC) will rapidly improve our understanding of both potential risk factors for CKD progression, as well as the scope of this disease among AIs. This study leverages the current CRIC study and incorporates the planned activities of the next phase of the study - "CRIC 2018" - by implementing contemporary CRIC protocols for kidney and cardiovascular measurement and outcomes.

Start: August 2020