Immune response to pneumococcal vaccination in aging renal transplant recipients Save

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

Silhouette
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
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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects with Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH) Save

Date Added
April 10th, 2018
PRO Number
Pro00076641
Researcher
Don Rockey

Silhouette
Keywords
Diabetes, Digestive System, Drug Studies, Exercise, Hypertension/ High Blood Pressure, Liver, Men's Health, Metabolism, Nutrition, Obesity
Summary

This is a Phase 2, randomized, double-blind, placebo-controlled study
evaluating the safety and efficacy of SEL, GS-0976, GS-9674, and
combinations in subjects with bridging fibrosis or compensated
cirrhosis due to NASH.
Subjects meeting the study's entry criteria will be randomly assigned in
a 2:2:1:1:1:1:2 ratio to 1 of 7 treatment groups, with approximately
70 subjects in each combination treatment group and approximately 35
subjects in each single agent or placebo group.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-8439
liverstudies@musc.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
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

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

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

The Role of Deoxysphingolipids in Peripheral Neuropathy Save

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

Silhouette
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

A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event driven Phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease Save

Date Added
October 10th, 2017
PRO Number
Pro00069773
Researcher
Roberto Pisoni

Silhouette
Keywords
Diabetes, Kidney
Summary

If you are an adult with type 2 diabetes mellitus and diabetic kidney disease, you may be eligible to take part in a clinical research study.
The purpose of this study is to find out if an investigational drug called finerenone slows the progression of diabetic kidney disease. Qualified participants will be randomly assigned to take either finerenone by mouth or placebo (inactive pill). Study medication, study visits, blood work and study procedures will be provided free of charge.

Institution
MUSC
Recruitment Contact
Lori Spillers
843-792-8166
spillerl@musc.edu

A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone on the reduction of cardiovascular morbidity and mortality in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease in addition to standard of care. Save

Date Added
October 10th, 2017
PRO Number
Pro00070030
Researcher
Roberto Pisoni

Silhouette
Keywords
Diabetes, Kidney
Summary

If you are an adult with type 2 diabetes mellitus and diabetic kidney disease, you may be eligible to take part in a clinical research study.
The purpose of this study is to find out if an investigational drug called finerenone slows the progression of diabetic kidney disease. Qualified participants will be randomly assigned to take either finerenone by mouth or placebo (inactive pill). Study medication, study visits, blood work and study procedures will be provided free of charge

Institution
MUSC
Recruitment Contact
Lori Spillers
843-792-8166
spillerl@musc.edu

Evaluation of ACCU-CHEK® Inform II System for Testing Arterial, Venous and Neonatal Heel Stick Samples in Critically Ill Patients Save

Date Added
September 26th, 2017
PRO Number
Pro00068789
Researcher
Gary Headden

Silhouette
Keywords
Diabetes, Infant, Non-interventional
Summary

The ACCU-CHEK Inform II is an FDA Food and Drug Administration) approved meter for checking blood glucose levels. This study is to gain FDA approval for use in critical care settings such as Intensive Care Units and Emergency Departments.

Institution
MUSC
Recruitment Contact
Robert Houck
843-792-3576
houckr@musc.edu

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