A PHASE III, MULTICENTER, RANDOMIZED, VISUAL ASSESSOR-MASKED, ACTIVE-COMPARATOR STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINIETICS OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA

Date Added
January 17th, 2020
PRO Number
Pro00091469
Researcher
W. Lloyd Clark

List of Studies

Keywords
Diabetes
Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of the PDS in patients with DME when treated every 24 weeks compared with intravitreal ranibizumab 0.5 mg every 4 weeks.

Institution
Palmetto
Recruitment Contact
Tiffany Swinford
8034045037
tswinford@palmettoretina.com

Characterization of patient-, provider-, and clinic-level factors associated with implementation, clinical outcomes, and sustainability of diabetes remote patient monitoring

Date Added
January 3rd, 2020
PRO Number
Pro00094517
Researcher
Elizabeth Kirkland

List of Studies

Keywords
Diabetes, Hypertension/ High Blood Pressure, Minorities
Summary

The purpose of this formative research is to explore and understand patient-, provider-, and systems-level characteristics that affect the sustainability and success of remote patient monitoring technology applied to diabetes chronic care. This will be completed through evaluation and analysis of the Technology Assisted Case Management in Low Income Adults with Type 2 Diabetes (TACM-2) implementation program. TACM-2 utilizes remote patient monitoring (RPM) of diabetes and hypertension to augment regular clinical care, with the ultimate goal of improving health outcomes particularly for low-income patients regardless of geographic location.

This exploratory study's broad goal is to characterize key barriers and facilitators to RPM use over time through a mixed methods design. We will utilize data gathered as part of an ongoing quality improvement program, TACM-2, to provide quantitative data on RPM uptake and effectiveness. We will also obtain qualitative and quantitative data from participating patients and healthcare teams. Our objectives are to assess:
1) patient-level variables that are associated with sustained device use and clinical outcomes over time,
2) patterns of device uptake and data transmission across South Carolina as markers of scalability and sustainability, and
3) patient-, clinic- and system-level barriers and facilitators of RPM implementation.

Institution
MUSC
Recruitment Contact
Ryan Kruis
843-792-4703
kruis@musc.edu

Reducing Disparities in Living Donation Among African Americans

Date Added
January 2nd, 2020
PRO Number
Pro00092908
Researcher
Derek DuBay

List of Studies

Keywords
Diabetes, Hypertension/ High Blood Pressure, Kidney, Transplant
Summary

Kidney donation from a living donor provides the kidney recipient with the best chance of a longterm survival of the transplanted kidney. White End Stage Renal Disease (ESRD) patients are 4 times more likely to recieve a living donor kidney than are African American (AA) ESRD patients. There are many reasons for this disparity in obtaining the benefits of living donation for AAs, including lack of knowledge regarding the living donation process. This study will provide a web-based educational intervention to overcome this knowledge deficiency with the hope that there will be an increase in patient interest in living donation which will result in more living donation kidney transplant inquiries by patients' family or friends.

Institution
MUSC
Recruitment Contact
Thomas Morinelli
843-792-5405
morinelt@musc.edu

Cellular Therapy for Type 1 Diabetes using Mesenchymal Stem Cells

Date Added
May 21st, 2019
PRO Number
Pro00085542
Researcher
Hongjun Wang

List of Studies

Keywords
Diabetes
Summary

The goal of this study is to determine the safety and efficacy of fresh metabolically active allogeneic umbilical cord-derived mesenchymal stromal cells (UC-MSCs) for the treatment of new-onset type 1 diabetes (T1D) and to understand the mechanisms of protection. If proven effective, such a strategy can be used as a therapeutic option for T1D patients and potentially other autoimmune disorders.

Institution
MUSC
Recruitment Contact
Danielle Woodford
843-792-6280
woodfordd@musc.edu

An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients with Heart Failure with Preserved Ejection Fraction (HFpEF) DELIVER - Dapagliflozin Evaluation to Improve the LIVEs of Patients with PReserved Ejection Fraction Heart Failure

Date Added
November 13th, 2018
PRO Number
Pro00083036
Researcher
Sheldon Litwin

List of Studies

Keywords
Diabetes, Heart, Hypertension/ High Blood Pressure
Summary

Volunteers are being asked to participate in a clinical research study to find out if the drug dapagliflozin is safe and effective compared to placebo (an inactive substance) in the treatment of people with heart failure with preserved ejection fraction (ability of the heart to relax and squeeze to pump out blood). AstraZeneca is doing this research to find out if the new medication called dapagliflozin will work and be safe for the treatment of heart failure in addition to standard therapy used for treatment of heart failure. The study is planned to go on for about 33 months and include 4700 patients from about 21 countries.

This research study is carried out to see if dapagliflozin is effective in preventing worsening of heart failure and improving survival in patients with heart failure and preserved systolic function. The placebo tablet will look identical with the dapagliflozin tablet. During the study participants will either receive dapagliflozin 10 mg once a day or an identical-looking placebo once a day. Which study drug subjects will receive throughout the study is decided at random by a computer (purely by chance, like the tossing of a coin). Subjects have a 50% chance of receiving dapagliflozin and a 50% chance of receiving placebo. Subjects and the study doctor will not know which study drug the participants receive.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu

Fenofibrate in Type 2 Diabetes- Novel Biomarkers and Mechanisms

Date Added
August 21st, 2018
PRO Number
Pro00079289
Researcher
Timothy Lyons

List of Studies

Keywords
Diabetes
Summary

People with diabetes develop irreversible eye, kidney, and nerve damage that is difficult to treat. Recent studies show that fenofibrate, a safe drug that has been used to lower cholesterol in the past, is effective in eye and kidney disease in patients with diabetes; but it is unclear how the drug actually works. We will do a ‘proteomic' analysis, a technology that measures hundreds of proteins in the blood, in 40 patients with diabetes before and after they take fenofibrate for six weeks. This work will help us understand how exactly the drug works, so that better treatment and preventive methods can be developed for the complications of diabetes.

Institution
MUSC
Recruitment Contact
Misti Leyva
8437921933
leyva@musc.edu

Impact of Disparities in Food Security on Glycemic Control and Health Care Utilization Among Youth and Young Adults with Diabetes

Date Added
March 19th, 2018
PRO Number
Pro00075894
Researcher
Angela Liese

List of Studies

Keywords
Adolescents, Diabetes, Environmental Factors, Ethnicity and Disease, Nutrition
Summary

Many youth and young adults (YYAs) with type 1 diabetes (T1D) and type 2 diabetes (T2D), particularly those of minority race/ethnicity, do not achieve optimal glycemic control and household food insecurity (HFI) may be a key barrier. HFI is the limited or uncertain availability of nutritionally adequate and safe foods. The SEARCH Food Security (SFS) cohort study is designed as an ancillary study to the ongoing NIH/NIDDK-funded SEARCH for Diabetes in Youth 4 Cohort study. The aims of the SFS study are to (1) Initiate a food insecurity cohort study of 1,187 YYAs aged 15-35 years (53% minority) with T1D and T2D by adding two data collection time points to the ongoing SEARCH 4 study in three of the five SEARCH sites, including South Carolina, Colorado and Washington; (2) Evaluate how HFI influences changes in glycemic control in YYAs with T1D and T2D; (3) Identify the pathways through which food insecurity may act; and (4) Evaluate the influence of HFI on changes in health care utilization and medical and non-medical health care costs in YYAs with T1D and T2D.

Institution
Greenville
Recruitment Contact
Jessica Stucker
803-777-1961
jstucker@mailbox.sc.edu

VAMC Non-Alcoholic Fatty Liver Disease (NAFLD) Research Database

Date Added
December 27th, 2017
PRO Number
Pro00056211
Researcher
Wing-Kin Syn

List of Studies

Keywords
Diabetes, Digestive System, Liver, Obesity
Summary

Non-Alcoholic fatty liver disease is the most common liver disease, and involves fat deposition in the liver. The fat in the liver can lead to inflammation, scarring, end stage liver disease and potential liver cancer. Some patients with fat in their liver do not see these changes, and our current understanding of why some people are not affected while others see progression of their disease is poor. We are currently in process of initiating studies to learn more about fatty liver disease, and having a database of patients at the VA medical center who are willing to participate in these studies and future studies would help both the patients learn about the new and upcoming therapies, and help the clinical investigators to quickly screen their patients and invite them to participate in their studies.

Institution
MUSC
Recruitment Contact
Margaret Morrison
843-408-6080
morrmarg@musc.edu

The Role of Deoxysphingolipids in Peripheral Neuropathy

Date Added
October 19th, 2017
PRO Number
Pro00070819
Researcher
Richard Klein

List of Studies

Keywords
Diabetes
Summary

Lipoproteins are particles in the blood which transport not only cholesterol and fats but also other lipids like sphingolipids. The purpose of this study is to investigate a type of sphingolipid, called deoxysphingolipid, in patients with diabetes who have nerve pain or neuropathy. These lipids can play a role in the development of diabetes complications, like neuropathy. We will investigate the role of this sphingolipid in the VLDL (Very Low Density Lipoprotein), LDL (Low Density Lipoprotein) and HDL (High Density Lipoprotein) in the development of nephropathy in diabetes. We will recruit patients with type 2 diabetes with or without neuropathy. Patients who volunteer for the study will be asked to donate a single blood sample to be used for isolation of lipoproteins. The sphingolipid composition of each lipoprotein class will be determined and the effect of the lipoproteins on the metabolism of cells in culture also determined.

Institution
MUSC
Recruitment Contact
Andrea Semler
843-789-6802
semleraj@musc.edu

Impact of Integrated HIV/NCD Screening on HIV Testing Update and Engagement in HIV Care: an RCT in Kisarawe, Tanzania

Date Added
July 5th, 2017
PRO Number
Pro00064733
Researcher
Michael Sweat

List of Studies

Keywords
Diabetes, HIV / AIDS, Hypertension/ High Blood Pressure
Summary

HIV testing is often shunned in community settings due to the stigma of HIV-centric services. Our recent pilot study strongly suggest that integration of a package of screening that include HIV, diabetes, and hypertension hold promise of substantially increasing the uptake of HIV testing while simultaneously providing direly needed community screening for non-communicable disease (NCDs) like diabetes and hypertension, which themselves are at epidemic levels in Sub-Saharan Africa. This study will examine whether integrating HIV screening with NCD screening will improve uptake of HIV testing and whether integrating HIV and NCD care will improve retention.

Institution
MUSC
Recruitment Contact
Michael Sweat
843-876-1082
sweatm@musc.edu



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