Research

U-M MEND Division, Dr. Rodica Pop-Busui

Dr. Pop-Busui has concentrated her scholarship and research efforts on translational and clinical research focused on understanding the mechanisms underlying the development of diabetes and prediabetes complications. The design and execution of her clinical trials are used to test novel therapies that target mechanisms for preventing chronic complications in patients with type 1 and type 2 diabetes. As a result of her efforts, Dr. Pop-Busui's research has been funded by divisions of the U.S. National Institutes of Health (NIH), such as the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), as well as the Juvenile Diabetes Research Foundation (JDRF), Centers for Disease Control and Prevention (CDC), private foundations, and industries.

Current Clinical Trials

U-M MEND Division, Dr. Rodica Pop-Busui

The Pop-Busui research team is actively involved in many studies of diabetes and its complications, in various stages of completion. Below are the clinical trials for which we are still recruiting patients. If you, or someone you know, would like to see if they are eligible to participate, please select the study title below to get more information.

Type 1 Diabetes Trials

Multi-center Trial in Adult and Pediatric Patients with Type 1 Diabetes Using Hybrid Closed Loop System at Home
The purpose of this study is to demonstrate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting for 12 months. The study will enroll patients from a wide range of ages, from 2-80 years old. INFORMATION: Cynthia Plunkett, RNC CCRC, cplunket@umich.edu or 734-936-8065.

Bydureon in Type 1 Diabetes
This Phase II trial examines the effect on glucose control of the drug exenatide (Bydureon) when injected under the skin of patients with type 1 diabetes. INFORMATION: Cynthia Plunkett, RNC CCRC, cplunket@umich.edu or 734-936-8065 or Ginny Leone, vleone@umich.edu or (734) 936-8656. View study on the UM Health Research Website.

Tissue-Specific Metabolic Reprogramming in Diabetic Complications
The purpose of this study is to assess changes in metabolic profiles associated with high blood sugar and diabetes. It also evaluates if sudden changes in blood sugars at very high and low levels promotes a "glycemic stress" that contributes to the damage of heart nerves, known as cardiovascular autonomic neuropathy, and ultimately to increased cardiovascular risk and arrhythmia in type 1 diabetes. INFORMATION: Cynthia Plunkett, RNC CCRC, cplunket@umich.edu or 734-936-8065 or Ginny Leone, vleone@umich.edu or (734) 936-8656.

TINSAL - Targeting Inflammation with Salsalate in Type 1 Diabetes Neuropathy
This phase III, single center, randomized, double-blind, placebo-controlled clinical trial examines whether a 12-month course of the drug salsalate will prevent the progression of diabetic neuropathy in subjects with type 1 diabetes and mild diabetic neuropathy. INFORMATION: Ginny Leone, vleone@umich.edu or (734) 936-8656. View study on the UM Health Research Website.

Type 2 Diabetes Trials

DAPA-CAN - Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients with Type 2 Diabetes (T2D)
The purpose of this study is to evaluate the effect of dapagliflozin, a FDA approved diabetes medication, on measures of nervous system function of the heart. INFORMATION: Ginny Leone, vleone@umich.edu or (734) 936-8656.

GRADE - Glycemia Reduction Approaches for Diabetes: A Comparative Effectiveness Study
This is the nation's first long-term review of how four widely used diabetes drugs work in combination with metformin, the most common first-line medication for treating type 2 diabetes. Patients with recent-onset diabetes are being recruited. The University of Michigan also serves as the economic analysis center for the nationwide study. INFORMATION: Andrea Waltje, RN, MS, waltjea@umich.edu or toll-free (855) 455-6559 or (734) 936-5037. View study on the UM Health Research Website.

Additional Ongoing Research Trials

There are many steps to doing research: writing the proposal; applying for funding; getting approval for the study methods, recruiting, screening, and treating groups of patients, collecting the lab results; analyzing the data; and writing the findings for publication. The studies below are in various stages of this process but are not recruiting new participants at this time.

Antipsychotic and Folate Pharmacogenomics -The purpose of this study is to evaluate the therapeutic effectiveness of folic acid supplementation in schizophrenia subjects and measure sustainability of this effect 8 weeks after supplementation withdrawal, as well as determining the role of MTHFR and COMT variants on endothelial functioning and metabolic improvements seen with folate supplementation.

CACTI - Complications and Comorbidities of Type 1 Diabetes - This study will examines the role of novel factors in vascular complications of type 1 diabetes that are not directly addressed by current preventive guidelines: insulin resistance, AGEs, oxidative stress, and endothelial dysfunction.

CAN - Cardiac Autonomic Neuropathy and Myocardial Dysfunction in Type 1 Diabetes (NIH) - This study tests if wide blood glucose fluctuations lead to the injury to heart nerves and impaired heart contractile (pumping) function and heart failure in patients with type 1 diabetes. Dr. Pop-Busui is the R01 grant holder and Principal Investigator of this study, which is only being done at the University of Michigan.

DEVOTE - Degludec Cardiovascular Outcomes Trial- This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.

EDIC - The Epidemiology of Diabetes Interventions and Complications - This observational study examines the risk factors associated with the long-term complications of type 1 diabetes. The study began in 1994 and follows the 1441 participants previously enrolled in the Diabetes Control and Complications Trial (DCCT).

Evaluation of Exenatide in Patients with Diabetic Neuropathy - Investigator-initiated research

Multinational Collaborative Evaluation of Corneal Confocal Microscopy as a Surrogate Endpoint for the Identification and Prediction of Diabetic Neuropathy in Type 1 Diabetes - This trial aims to derive and validate specific in vivo Corneal Confocal Microscopy (CCM) parameter thresholds for the identification of diabetic polyneuropathy, and - more importantly - the identification of individuals at future risk.

PERL - Preventing Early Renal Loss in Type 1 Diabetics (NIH/NIDDK) - The PERL Study tests whether a known drug for gout - allopurinol - slows or prevents kidney disease in patients with type 1 diabetes.

Post Approval Study of the TS (Threshold Suspend) Feature with a Sensor-Augmented Pump System - The Post Approval Study is a longitudinal, multi-center trial that aims to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin pump in patients 16 and older with insulin requiring diabetes. The study will measure the change in A1C from baseline over a period of one year while subjects are wearing the Medtronic MiniMed® 530G insulin pump.

SEARCH - Surveillance, Natural History, Quality of Care and Outcomes of Diabetes Mellitus with Onset in Childhood and Adolescence (NIH/NIDDK) -The goals of this project are to monitor the onset of diabetic autonomic and peripheral neuropathy in children. This is a collaboration with the Centers for Disease Control and Prevention (CDC). 

 

Past Major Trials

U-M MEND Division, Dr. Pop-Busui and Cynthia Plunkett

Dr. Pop-Busui has participated in some of the most important diabetes studies to date, the results of which have changed the ways in which diabetes is managed around the world. Many of the studies were funded by the U.S. National Institutes of Health (NIH), as well as other top diabetes research organizations such as the Juvenile Diabetes Research Foundation (JDRF).

The following is a selection of the closed research trials in which Dr. Pop-Busui has participated: