Cellular Therapy for Type 1 Diabetes using Mesenchymal Stem Cells Save

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

List of Studies


Profiles_link
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

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of SOtagLiflozin on Clinical Outcomes in HemOdynamIcally STable Patients with Type 2 Diabetes POST Worsening Heart Failure Save

Date Added
May 14th, 2019
PRO Number
Pro00082460
Researcher
Bhavadharini Ramu

List of Studies

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Keywords
Cardiovascular, Diabetes
Summary

Sotagliflozin (SAR439954) is a medicine you take by mouth that is being developed by Sanofi for the potential treatment of type 2 diabetes (T2DM). Sotagliflozin is an "investigational drug". The purpose of the study is to show that sotagliflozin can decrease the risk of cardiovascular death, or decreases the risk of being hospitalized for heart failure. Furthermore, the study will observe whether sotagliflozin reduces the risk of kidney disease, or if sotagliflozin could lead to changes in the way you use other medications. The study will last about 3 years and involve about 4000 participants. The Study has 3 main periods, as follows: Screening, a Double-Blind Treatment period, and a Follow-Up period.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@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 Save

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

List of Studies

Silhouette
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

Using Portable Telemedicine to Connect homebound patients to medical and social resources (Connected Home) Save

Date Added
September 19th, 2018
PRO Number
Pro00078976
Researcher
Gayenell Magwood

List of Studies


Profiles_link
Keywords
Diabetes, Hypertension/ High Blood Pressure
Summary

This is a research study to find out how acceptable and how to deliver a Home Care Tele-Visits with adults diagnosed with Diabetes Mellitus (Diabetes) and/or Hypertension (high blood pressure). This study will consist of three at home visits with a Medical Tele-Assistant. Each visit will be scheduled to accommodate the participant's schedule and will be about 2-3 weeks apart. During the 2nd and 3rd visit the participant will able to use mobile technology to visit with their doctor and community/social resources (family member or friend). Participants will not be expected to pay for these in-home visits, and will be compensated for their time and participation.

This study is a pilot project, meaning that the goal is to gather data about how easily technology can be used in the home to provide access to health care providers, and social/community resources. Participants may benefit from participating in this study, but that cannot be guaranteed. There are minimal risks associated with participating in this study, such as a loss of privacy while using the Telemedicine System.

Institution
MUSC
Recruitment Contact
Stephanie Slan
843-792-5032
slans@musc.edu

Fenofibrate in Type 2 Diabetes- Novel Biomarkers and Mechanisms Save

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

List of Studies

Silhouette
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

Immune response to pneumococcal vaccination in aging renal transplant recipients Save

Date Added
June 19th, 2018
PRO Number
Pro00077548
Researcher
Maria anna Westerink

List of Studies

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Keywords
Aging, Diabetes, Geriatrics, Healthy Volunteer Studies, Hypertension/ High Blood Pressure, Immune System, Kidney, Transplant, Vaccine
Summary

We will study how well the relatively new FDA approved pneumonia vaccine can protect older renal transplant recipients against pneumococcal illness. We will specifically study the group of renal transplants in whom the cause of renal failure was either diabetes mellitus II and/or hyoertension. We will compare the findings against those we find in younger renal transplant recipients, older healthy individuals and older persons with diabetes but normal kidney function. Healthy younger individuals will serve as controls for optimal vaccine response.

Institution
MUSC
Recruitment Contact
Myroslawa Happe
843-792-2218
soloshch@musc.edu

Improving Healthy Outcomes through Fresh Food Access Save

Date Added
April 18th, 2018
PRO Number
Pro00073034
Researcher
Mark Humphrey

List of Studies

Keywords
Diabetes, Hypertension/ High Blood Pressure, Nutrition, Obesity
Summary

The proposed project recognizes the relationship between food insecurity and social determinants of health. By developing a strong clinic/organization linkage between specific Palmetto Health clinics and FoodShare, we will be able to determine if increasing access to fresh produce through an every other week produce box, participation in cooking classes, and clinician reinforcement improves health outcomes for patients who are identified as food insecure.

Institution
Palmetto
Recruitment Contact
Beverly Wilson
803-665-7800
beverly.wilson@uscmed.sc.edu

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

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

Diabetes, modified lipoproteins, and preeclampsia Save

Date Added
January 10th, 2018
PRO Number
Pro00070368
Researcher
Timothy Lyons

List of Studies

Silhouette
Keywords
Cardiovascular, Diabetes, Hypertension/ High Blood Pressure, Pregnancy
Summary

Pre-eclampsia (PE) happens in pregnancy. It features new onset high blood pressure. It is a major cause of problems to the mother and unborn child. It can lead to health problems in mother and child in the future, which causes a public health problem. We do not know everything about it, but we think it starts in the placenta (the organ that nourishes the unborn child). At this time, we do not know who will get PE. We want to study the placenta, to learn more about the disease.

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

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

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

List of Studies

Silhouette
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
Akshay Shetty
404-941-6717
shetty@musc.edu

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