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Research

Tulane Diabetes Research Program


Franck Mauvais-Jarvais, MD, PhD

The mission of the Tulane Diabetes Research Program is to provide a collaborative research community and infrastructure to Tulane research investigators studying the molecular bases and therapeutic avenues for diabetes mellitus, obesity and their complications.  

Franck Mauvais-Jarvis, MD, PhD, Director of the Tulane Diabetes Research Program, Price-Goldsmith Professor of Nutrition


lab

A variety of research resources are available in the Section of Endocrinology. A list of current studies is found below. These research projects and others through the Clinical Trials Cooperative provide numerous opportunities for research and scholarly publication, and are an integral part of the Endocrinology department. Publications relating to this research are found on our publications page. For more publications, please reference specific faculty or fellow pages.


Current Studies



GS4997 Study


Protocol #GS-US-223-1015 – “A Phase 2 Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy, Safety and Tolerability of GS 4997 in Subjects with Diabetic Kidney Disease”


PI: Vivian A. Fonseca, MD


PROTOCOL SUMMARY:

The purpose of this research study is to explore whether GS-4997 slows or stops progression of kidney disease in patients with DKD.


Study Status: Recruiting study subjects




CARMELINA


Protocol #1218.22 – “A multicenter, international, randomized, parallel group, double blind, placebo-controlled CArdiovascular Safety & Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk” – CARMELINA


PI: Tina Thethi, MD


PROTOCOL SUMMARY:

The purpose of this research study is to investigate the impact of treatment with a drug called linagliptin on the long–term occurrence of selected complications of cardiovascular disease (for example  stroke or heart attack), as compared to the placebo, in patients with type 2 diabetes mellitus already receiving the standard of care treatment. In addition, the study will investigate the impact of treatment with linagliptin on kidney disease in patients with type 2 diabetes mellitus.


Study Status: Recruiting study subjects




ABPM


To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure:  A Pilot Study


PI: Tina Thethi, MD


PROTOCOL SUMMARY:

A research study evaluating the effects of a drug: liraglutide (Victoza) on blood pressure. Liraglutide is a drug approved by FDA (Food and Drug Administration) to treat Type 2 Diabetes Mellitus. It is given under the skin daily.


Blood pressure will be monitored using the 24 hour Ambulatory Blood Pressure monitor: a device that monitors  blood pressure while continuing normal activity.  We will also measure the endothelial function using a machine: ENDO PAT.  This is a non-invasive diagnostic test which is done in the doctor’s office. The test usually takes about 15 minutes. It is not painful. It generates an EndoScore which indicates the current state of the endothelial health.


Study Status: Recruiting study subjects




ITCA 107


Protocol #ITCA 650-CLP-107 – “A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 Diabetes”


PI: Tina Thethi, MD


PROTOCOL SUMMARY:

The purpose of this research study is to evaluate the number and type of events associated with body systems related to the heart and blood vessels (cardiovascular system) and to test the safety and effectiveness of long-term treatment with ITCA 650 with diet and exercise and Standard of Care medication(s) in people with diabetes.


Study Status: Recruiting study subjects




SUSTAIN


Protocol #NN9535-3744 – SUSTAIN™ 6 – Long-term Outcomes - “A long-term, randomized, double-blind, placebo-controlled, multinational, multi-centre trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes”


PI: Tina Thethi, MD


PROTOCOL SUMMARY:

The purpose of this research study is to investigate whether subjects with type 2 diabetes with increased risk of cardiovascular events can safely and effectively add semaglutide to their current treatment. In addition, the trial will also test the long-term effects of semaglutide on heart and blood vessels, as well as on regulation of blood sugar, body weight, quality of life, and other specific parameters.


Study Status: Recruiting study subjects




EndoBarrier


Protocol #09-1 – “A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier® Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents”


PI: Vivian A. Fonseca, MD


PROTOCOL SUMMARY:

The purpose of this research study is to evaluate the safety and initial efficacy (the effectiveness) of the EndoBarrier Gastrointestinal Liner System in uncontrolled Type 2 diabetic subjects who are also obese.


Study website: www.endobarriertrial.com


Study Status: Recruiting study subjects




Mesoblast


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


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


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, which are proteins found in the urine also known as markers. 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: Recruiting study subjects




LEADER


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




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