Strelitz Diabetes Center Clinical Trials

Reducing diabetes distress in Adults with newly diagnosed Type 2 Diabetes:
A Pilot Study

Primary Investigator: Dr. Chinelo, Okigbo, MD

Sponsor: EVMS

Summary: To study the efficacy of a virtual health coaching intervention VS. standard of care on reducing diabetes distress in newly Dx diabetics.

Point of contact: 

• Abby McMillan | McMillAM@EVMS.edu (or odu.edu) | 757-446-5161

Start date: N/A. Currently recruiting and enrolling participants.

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

• Have Type 2 Diabetes diagnosis within the last 12 months.
• Have access to a mobile device, tablet, desktop for virtual education and/or health coaching.
• Registered patient of EVMS.

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 analyze 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 through June 2024.

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

• Have hypertension.
• Are currently 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.

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: 

• Taneisha Sears | SearsTL@EVMS.edu (or SearsTL@odu.edu) | 757-446-5285

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 a history CVD/CKD
• 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: 

• Anna Stoiber, MPH, BSN, RN | StoibeAM@EVMS.edu (or odu.edu) | 757-446-8477

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: 

• Jordan Pettaway, MS | PettawJL@EVMS.edu (or odu.edu) | 757-446-7445

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. 

Primary Investigator:  Dr. Elias Siraj

Summary: To study the efficacy and safety of the current hard gelatin capsule formulation of NRD135S.E1 in the treatment of PDPN.

Sponsor: Harvard University and the NIH

Points of contact:

• Jordan Pettaway, MS | PettawJL@evms.edu (or odu.edu) | 757-446-7445

Start date: N/A. Currently recruiting and enrolling participants.

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

• Have a body mass index (BMI)  40 kg/m^2.
• Have Type 2 Diabetes.
• Have chronic DPNP.

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:

• Jan Patel | PatelJ1@evms.edu (or odu.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.

Primary Investigator:  Dr. Elias Siraj

Summary: To study the efficacy and safety of LX9211 Phosphate (an AAK1) in reducing pain related to painful diabetic peripheral neuropathy (PDPN).

Sponsor: Lexicon Pharmaceuticals, Inc.

Points of contact:

• Anna Stoiber, MPH, BSN, RN | StoibeAM@EVMS.edu (or odu.edu) | 757-446-8477

Start date: N/A. Currently recruiting and enrolling participants.

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

• Be 18 years or older.
• Have Type 1 OR Type 2 Diabetes.
• Have chronic DPNP.
• Have an HbA1c level no higher than 11%.
• Currently not taking more than one medication for DPNP.