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Research

Current Studies Continued...


Mesoblast Study

Protocol #MSB-DM003 – “A Randomized, Placebo-Controlled, Dose-Escalation Study to Assess the Safety and Tolerability of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients with Type 2 Diabetes Sub-optimally Controlled on Metformin”


PI: Vivian A. Fonseca, MD


PROTOCOL SUMMARY:

The purpose of this research study is to look at:

  • The safety of MPC therapy
  •                  
  • How safe and effective MPC therapy is compared to placebo (normal saline or simple
    salt water very much like the solution found normally in your body.  This solution
    contains no medication nor does it contain any stem cells)

  • How well MPC therapy works for the treatment of type 2 diabetes when given to
    patients already on metformin treatment

MPCs are special cells (sometimes referred to as stem cells) that were obtained from the bone marrow of adult human donors who donated cells for the purpose of this study.


Study Status: Study closed to enrollment



UAGT Study

Potential of Urinary AGT as a Novel Biomarker for Intrarenal RAS Activity in T1DM


PI: Vivian A. Fonseca, MD


PROTOCOL SUMMARY:

The purpose of this research study is to investigate a more sensitive and specific test for determining the early presence of diabetes nephropathy, a disease of the kidneys.  Because early detection presents the option of early treatment and prevention of progression of the disease, developing a simple test that can identify signs of this disease at an early point in the disease process can potentially both save lives and improve outcomes for patients with diabetes.


Study Status: Recruiting study subjects



UFLC Study


Effect of renin-angiotensin-system blockade on urinary free light chains in patients with type 2 diabetes mellitus


PI: Tina Thethi, MD


PROTOCOL SUMMARY:

The purpose of this research study is to see the effect of some of the medicines used for control of high blood pressure [Ace Inhibitors (Ace Inh) and angiotensin receptor blockers (ARB)] on urinary free light chains.


Diabetes mellitus is one of the main reasons for kidney disease.  The number of people with both, diabetes mellitus and kidney disease are increasing.  Currently, measuring protein in the urine, called microalbumin creatinine ratio is done to see if patients with diabetes mellitus and or high blood pressure have kidney disease.  We are trying to study if there are other proteins in the urine that are increased before the increase in urine microalbumin creatinine ratio.  We are interested in knowing this, to see if kidney disease can be seen and therefore treated earlier than it can currently be, so further worsening can be prevented.


There is another class of protein, called light chains that are found in the urine. There are two kinds of light chains – kappa and lambda light chains. The urinary free light chains have been found to be higher in people with diabetes mellitus.


Study Status: Study closed to enrollment



LEADER Study


Protocol #EX2211-3748 – “LEADER Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results A long-term, multi-centre, international, randomised double-blind, placebo-controlled trial to determine liraglutide effects on cardiovascular events”


PI: Vivian A. Fonseca, MD


PROTOCOL SUMMARY:

The purpose of this research study is determine the effect of liraglutide on heart or blood vessels in subjects with type 2 diabetes.


Study website: www.leadertrial.com


Study Status: Study closed to enrollment



Variation in A1c Study


“Impact of Biological Variation in A1c on Mortality, Cardiovascular Events, and Hypoglycemia in the ACCORD Study”


PI: Vivian A. Fonseca, MD


PROTOCOL SUMMARY:

The purpose of this research study is to evaluate data from the Action top control cardiovascular risk in diabetes (ACCORD) study to determine if biological variation in hemoglobin A1c is associated with clinical outcomes of intensive glycemic control in type 2 diabetes. We will use a novel hemoglobin glycation index (HGI) to assess variation in A1c caused by factors other than mean blood glucose and determine if HGI is associated with individual risk for mortality, cardiovascular events, microvascular disease or hypoglycemia. The results could help explain excess mortality in the ACCORD intensive treatment group and may also validate the clinical use of HGI for assessment of both acute and chronic complications risk in type 2 diabetes.



Diabetic Kidney Disease Study

Novel Serum and Urinary Biomarkers of Diabetic Kidney Disease


PI: Vivian A. Fonseca, MD


PROTOCOL SUMMARY:

The overall design of this research is to utilize banked samples from the Action to Control Cardiovascular Disease (ACCORD) trial - a randomized, 2 x 2 factorial design trial of intensive glycemic control (target HbA1C < 6.0%) vs. standard therapy (target HbA1C 7.0 to 7.9%) in 10,251 type 2 diabetics. The intervention lasted for 3.7 years, and total follow-up of patients averaged over 5 years. Predefined secondary microvascular outcomes were measures of kidney function, diabetic eye complications, and peripheral neuropathy. Intensive glycemic control reduced the incidence of microalbuminuria and macroalbuminuria by 21% and 32%, respectively. In addition, the progression of retinopathy, another microvascular outcome, was reduced from 10.4% to 7.3% with intensive glycemic control. However, neither the rate of development of incident CKD (doubling of creatinine and 20 ml/min decrease in eGFR) (5.8% vs. 5.1% in the intensive and standard arms, respectively) nor end-stage renal disease (2.1% vs. 2.2%) differed between the two glycemia-treatment arms. The reasons for these outcomes need to be explored.



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