Dr. Rodica Pop-Busui, MD
Claim this profileUniversity of Michigan
Studies Diabetes
Studies Type 1 Diabetes
8 reported clinical trials
11 drugs studied
Affiliated Hospitals
Clinical Trials Rodica Pop-Busui, MD is currently running
Sotagliflozin
for Diabetic Kidney Disease
Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.
Recruiting1 award Phase 3
Fish Oil + Salsalate
for Diabetic Neuropathy
Diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes, affecting about 50% of patients with diabetes and leading to severe morbidity, poor quality of life, high mortality, and high health care costs. Due to the complex structure and anatomy of the peripheral nervous system, DPN presents with a very broad spectrum of clinical symptoms and deficits, including severe pain, sensory deficits, foot ulcers and amputations. Presently there is no treatment for DPN and even with good blood glucose control DPN develops especially in patients with type 2 diabetes. There is a need to identify effective interventions for DPN. Preclinical studies have provided evidence that the combination of fish oil and salsalate is an effective treatment of DPN. The human subject study to be performed will examine the effect of fish oil with and without salsalate on the blood lipid profile and circulating metabolites of omega-3 polyunsaturated fatty acids (PUFA). Fish oil is an excellent source for the nutrition dependent omega-3 PUFA, primarily eicosapentaenoic acid (EPA; 20:5) and docosahexaenoic acid (DHA; 22:6). These fatty acids are the source of anti-inflammatory metabolites known as resolvin, neuroprotectin and maresin. Preclinical studies have also demonstrated that the metabolites of EPA and DHA are neuroprotective. Furthermore, when fish oil is combined with salsalate the production of these metabolites is increased in vivo. Thus, the investigators hypothesize that fish oil and salsalate will be an effective therapy of DPN. However, prior to doing a formal study of the effect of fish oil + salsalate on DPN there is a need to learn more about what concentration combination will provide the most efficacious effect on the omega-3 index (defined as the sum of EPA and DHA, as a percentage of total fatty acids in red blood cells) and that will safely increase the production of the anti-inflammatory metabolites. These studies will be performed at two sites the University of Iowa (Dr. Yorek) and University of Michigan (Dr. Pop-Busui) by treating human subjects with type 2 diabetes and DPN with either 2g or 4g of fish oil per day (capsules) for 4 months and then adding salsalate 1.5 g or 3g per day (tablets) to the fish oil treatments for an additional 2 months. At baseline and after treatment with fish oil alone and after treatment with the combination of fish oil and salsalate the omega-3 index and levels of circulating omega-3 PUFA metabolites will be determined as primary endpoints. Secondary endpoints will include determination of circulatory inflammatory markers and non-invasive measurements for DPN. The risks to subjects are minimal and are very reasonable in relation to the importance of the knowledge to be gained.
Recruiting1 award Phase 1 & 26 criteria
More about Rodica Pop-Busui, MD
Clinical Trial Related1 year of experience running clinical trials · Led 8 trials as a Principal Investigator · 3 Active Clinical TrialsTreatments Rodica Pop-Busui, MD has experience with
- Fish Oil Concentrate
- Salsalate Oral Tablet
- 670G And 770G Insulin Pump
- Subject's Current Diabetes Therapy
- Observational
- C-myc Biomarker Study
Breakdown of trials Rodica Pop-Busui, MD has run
Diabetes
Type 1 Diabetes
Diabetic Foot Ulcer
Plantar Ulcers
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Frequently asked questions
Do I need insurance to participate in a trial?
Almost all clinical trials will cover the cost of the ‘trial drug’ — so no insurance is required for this. For trials where this trial drug is given alongside an already-approved medication, there may be a cost (which your insurance would normally cover).
What does Rodica Pop-Busui, MD specialize in?
Rodica Pop-Busui, MD focuses on Diabetes and Type 1 Diabetes. In particular, much of their work with Diabetes has involved treating patients, or patients who are undergoing treatment.
Is Rodica Pop-Busui, MD currently recruiting for clinical trials?
Yes, Rodica Pop-Busui, MD is currently recruiting for 2 clinical trials in Ann Arbor Michigan. If you're interested in participating, you should apply.
Are there any treatments that Rodica Pop-Busui, MD has studied deeply?
Yes, Rodica Pop-Busui, MD has studied treatments such as Fish Oil Concentrate, Salsalate Oral Tablet, 670G and 770G Insulin Pump.
What is the best way to schedule an appointment with Rodica Pop-Busui, MD?
Apply for one of the trials that Rodica Pop-Busui, MD is conducting.
What is the office address of Rodica Pop-Busui, MD?
The office of Rodica Pop-Busui, MD is located at: University of Michigan, Ann Arbor, Michigan 48109 United States. This is the address for their practice at the University of Michigan.
Is there any support for travel costs?
The coverage of travel expenses can vary greatly between different clinical trials. Please see more financial detail in the trials you’re interested to apply.
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