Effects of Semaglutide on Blood Flow and Brain Barrier in Type 2 Diabetes

Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes

This study is testing if the diabetes medication semaglutide can improve blood flow in the brain and protect against strokes in people aged 40-65 with type 2 diabetes.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 40 Years to 65 Years
• Sex: All
• Sponsor: University of Washington (other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT05780905 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates how semaglutide, a medication for type 2 diabetes, affects intracranial blood flow and blood-brain barrier permeability. Participants aged 40-65 with type 2 diabetes will be randomly assigned to receive either semaglutide or a placebo. The study will utilize magnetic resonance imaging to measure changes in blood flow and barrier permeability over one year. The goal is to understand the neuroprotective effects of semaglutide and its potential role in reducing stroke risk in patients with diabetes.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 40-65 with type 2 diabetes for at least three years and controlled HbA1C levels between 7% and 10%.

Not a fit: Patients with contraindications to MRI, severe kidney dysfunction, or those currently on similar medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with type 2 diabetes, potentially reducing their risk of stroke.

How similar studies have performed: Previous studies have indicated that semaglutide may reduce stroke incidence in type 2 diabetes, suggesting a promising avenue for further investigation.

Eligibility criteria

Inclusion Criteria:

1. Men and women 40-65 years of age
2. Subjects with type-2 diabetes \>= 3 years and HbA1C 7%-10% with blood sugar control medications including insulin, metformin, sulfonylureas, or SGLT2 inhibitors
3. Medically stable
4. Has not received any investigational drug in the past 6 months
5. Willing to participate and sign informed consent.

Exclusion Criteria:

1. Contraindication to MRI or contrast agent
2. eGFR\<45 mL/min/1.73m2 (eGFR is a measurement of kidney function)
3. Currently treated with glucagon-like peptide-1 receptor antagonist (same drug class as study intervention)
4. Unable to perform home-glucose monitoring
5. Currently need more than 100 units of insulin daily
6. Uncontrolled hypertension with systolic blood pressure (SBP)\>180 mmHg or diastolic blood pressure (DBP)\>100 mmHg
7. LDL-C\>130 mg/dL or not on stable statin therapy in the past 6 months
8. Treatment with pioglitazone in the past 3 months
9. History of pancreatitis
10. History of myocardial infarction, stroke or transient ischemic attack
11. History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
12. Hypersensitivity to semaglutide or any of the product components
13. Participating in other clinical trial
14. Women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who have a positive pregnancy test at enrollment or who are breastfeeding or who plan to become pregnant in the next 15 months.

Where this trial is running

Seattle, Washington

• University of Washington - Harborview Medical Center — Seattle, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Francis Kim, MD — University of Washington
• Study coordinator: Francis Kim, MD

Conditions: Diabetes Mellitus, Type 2, Stroke or Transient Ischemic Attack