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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



DUAVEE


Pilot study of DUAVEE in preventing metabolic dysfunction in
postmenopausal women


PI: Franck Mauvais-Jarvis, MD, PhD


PROTOCOL SUMMARY:

The purpose of this research study is to determine if DUAVEE (Conjugated Estrogens/Bazedoxifene, a new prescription medicine that contains a mixture of estrogen and bazedoxifene) can reduce obesity and associated pre-diabetes in obese postmenopausal women during a short study of 3 months.


Study Status: Recruiting study subjects




GS-US-225-1015 Box Cover


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: ENDOPAT.  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.


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



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