Strelitz Diabetes Center Clinical Trials

ACHIEVE - 4: A Phase 3, Open-Label Study of a Once Daily Oral GLP-1 Compared with Insulin Glargine in Adult Participants with Type 2 Diabetes Mellitus and Obesity or Overweight at Increase Cardiovascular Risk

Primary Investigator: Dr. Elias Siraj, MD

Sponsor: Eli Lilly and Company

Summary: The study will test how safe and well the investigational medicine works for blood glucose and weight management compared with insulin therapy.

Point of contact: 

• Amber Ingram, MS, CRCC | IngramAM@EVMS.edu | 757-446-8485

Start date: N/A. Currently recruiting participants.

Eligibility: You may be eligible to participate in this study if you:

• Are 18 years or older.
• Have diabetes Type 2 and take at least one medication for diabetes management.
• Have or at risk for heart disease, stroke, or other blood vessel diseases, or have kidney disease.

Nevro HFX™: A Post-Market, Multicenter, Prospective, Randomized Controlled Study to Evaluate Pain and
Neurological Function with 10 kHz Spinal Cord Stimulation Treatment of Chronic Intractable
Pain Associated with Diabetic Peripheral Neuropathy

Primary Investigator: Dr. Elias Siraj, MD

Sponsor: Nevro Corporation

Summary: The purpose of this study is to evaluate Nevro HFX™ as a treatment for painful diabetic neuropathy. The goal of this study is to use spinal cord stimulation (SCS) therapy for pain and neurological function improvement in patients with chronic lower limb (LL) pain associated with diabetic peripheral neuropathy, AKA painful diabetic neuropathy (PDN).

Point of contact: 

• Taneisha Sears, MPH | SearsTL@EVMS.edu | 757-446-5285

Start date: N/A. Currently recruiting participants.

Eligibility: You may be eligible to participate in this study if you:

• Are 22 years or older
• Have diabetes AND diabetic peripheral neuopathy (AKA painful diabetic europathy, PDN).
• Have PDN symptoms for at least 12 months.
• Have a HbA1c level less than or equal to 10% based on measurement at enrollment.

Advance-HTN: A Randomized, Double-Blind, Placebo Controlled, Parallel ARm, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension

Primary Investigator: Dr. Elias Siraj, MD

Sponsor: Mineralys Therapeutics

Summary: The purpose of this study is to anlayze the efficacy of Lorundrostat (the study drug) for the treatment of hypertension in participants with uncontrolled high blood pressure (hypertension). This study is a clinical trial aimed to help contribute to research that may lead to more effective treatment options for uncontrolled blood pressure. The information obtained from the ADVANCE-HTN may help advance the treatment of future patients with uncontrolled blood pressure and will provide important information about how well people respond to the study drug being investigated. 

Point of contact: 

• Taneisha Sears, MPH | SearsTL@EVMS.edu | 757-446-5285

Start date: N/A. Currently recruiting participants thorugh June 2024.

Eligibility: You may be eligible to participate in this study if you:

• Have hypertension.
• Are currenlty taking TWO or more medications for uncontrolled hypertension.
• Are currently not working night shifts.

A Study to Test the Efficacy and Cardiovascular Safety of BI-Dual GLP1-GCGR Agonist Compared with a Placebo in People who are Overweight/Obese with CVD or CKD and/or at Least 2 Weight-Related Complications or Risks Factors for CVD.

Primary Investigator: Dr. Elias Siraj, MD

Study Sponsor: Boehringer Ingelheim

Summary: The purpose of this study is to analyze the effects of an investigational drug on the cardiovascular safety in people who are overweight/obese. 

Point of contact: 

• Amber Ingram, MS, CRCC | IngramAM@EVMS.edu | 757-446-8485

Start date: N/A. Currently recruiting participants.

Eligibility: You may be eligible to participate in this study if you:

• Have a body mass index (BMI) of at least 27 kg/m^2
• Have CVD and/or at least 2 obesity related CV risk factors or comorbidities.
• Are not taking a GLP-1 medication.

FINE-One: A Parallel-Group, Randomized, Prospective, Interventional, Double-Blind, Multicenter Global Phase 3 Study To Investigate The Efficacy And Safety Of Finerenone Versus Placebo, In Addition To Standard Of Care, In Participants With Chronic Kidney Disease And Type 1 Diabetes

Primary Investigator: Dr. Elias Siraj, MD

Sponsor: Bayer

Summary: The purpose of this study is to look at the efficacy and safety of the investigational drug, Finerenone versus a placebo (in addition to standard of care) in participants with chronic kidney disease and type 1 diabetes. 

Point of contact: 

• Taneisha Sears, MPH | SearsTL@EVMS.edu | 757-446-5285

Start date: N/A. Currently recruiting participants.

Eligibility: You may be eligible to participate in this study if you:

• Are 18 years or older.
• Have TYPE 1 diabetes.
• Have chronic kidney disease (CKD).
• Have a HbA1c less than 10%.

MAP: Metformin in Alzheimer’s Dementia Prevention

Primary Investigator: Dr. Hamid Okhravi, MD

Sponsor: National Institute on Aging

Summary: The purpose of this study is to test the efficacy of Metformin in the prevention of cognitive decline associated with Alzheimer’s dementia.

Point of contact: 

• Amber Ingram, MS, CRCC | IngramAM@EVMS.edu | 757-446-8485

Start date: N/A. Currently recruiting participants.

Eligibility: You may be eligible to participate in this study if you:

• Are diagnosed with a mild cognitive impairment (MCI).
• Are 55-90 years old.
• Have no known history of diabetes.
• Have no diagnosis of dementia based no the DSM-V criteria.
• Have sufficient vision and hearing capabilities. 

Pathfinder 2: Evaluating the Safety and Performance of the GRAIL Multi- Cancer Early Detection Test (MCED) in an Eligible Screening Population

Primary Investigator:  Dr. Sami Tahhan, MD

Summary: The purpose of this study is to analyze the performance, impact, and efficacy of a multi-cancer early detection (MCED) test called Galleri. The test can detect up to 50 biomarkers for cancer through a simple blood draw.

Sponsor: GRAIL

Points of contact:

• Jordan Pettaway | PettawJL@evms.edu | 757-446-7445
• Abby McMillan, MS, EP-C | McMillAM@evms.edu | 757-446-5161
• Jan Patel | PatelJ1@evms.edu | 757-446-0577

Start date: 2023, currently recruiting participants.

Eligibility: You may be eligible to participate in this study if you:

• Are 50-80 years old.
• Have not been diagnosed with cancer within the last 3 years.
• Are a registered EVMS patient.

Nutritional Lifestyle-based Study: Impact Of A Culturally Tailored, Personalized, Mobile Health-Based Lifestyle Intervention In Improving Metabolic Outcomes Of Overweight And Obese African Americans With Prediabetes In Underserved Communities Of Southeastern Virginia

Primary Investigator: Dr. Henri Parson, PhD

Sponsor: American Diabetes Association (ADA)

Summary: The purpose of this study is to identify effective and sustainable dietary lifestyle interventions for African American communities in Southeastern Virginia and to assess the efficacy of a culturally tailored mobile Health-based lifestyle intervention. The goal is to determine if a personal nutrition program can help you eat healthier without giving up your favorite flavors and your cultures' cuisines/cooking.

Point of contacts:

• Jordan Pettaway | PettawJL@evms.edu | 757-446-7445
• Abby McMillan, MS, EP-C | McMillAM@evms.edu | 757-446-5161
• Jan Patel | PatelJ1@evms.edu | 757-446-0577

Start date: 2024. Currently recruiting participants.

Eligibility: You may be eligible to participate in this study if you:

• Self identify as an African American
• Are 25-55 years old.
• Are diagnosed with Pre-diabetes and/or at risk for type 2 diabetes.
• Have a body mass index (BMI) between 25-40kg/m^2.