RecruitingPhase 4NCT05780905

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

Sponsor

University of Washington

Enrollment

50 participants

Start Date

Jan 11, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Stroke (CVA) or Transient Ischemic Attack

Summary

A human subjects research study, the primary purpose of which is to assess the EFFECTS OF SEMAGLUTIDE ON INTRACRANIAL BLOOD FLOW AND BLOOD-BRAIN BARRIER PERMEABILITY IN TYPE-2 DIABETES (T2D) through testing of the intervention on patients in a clinical setting. The study will randomize subjects with diabetes to either semaglutide or matching placebo. Magnetic resonance images will be primary endpoint measured at baseline and at one year to assess effect of this FDA approved medication. Given the available evidence supporting the neuroprotective effect of this drug class and stroke reduction with semaglutide, and the investigators preliminary data showing that T2D had significantly reduced total number of distal arterial branches in the brain than non-T2D, the investigators expect treatment with semaglutide will be associated with improved intracranial blood flow condition.

Eligibility

Min Age: 40 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether semaglutide — a medication widely used for type 2 diabetes and weight loss (brand names include Ozempic and Wegovy) — affects blood flow to the brain and the integrity of the brain's protective barrier in people with type 2 diabetes. Understanding these effects could reveal new benefits or risks of this increasingly popular drug. **You may be eligible if:** - You are between 40 and 65 years old - You have had type 2 diabetes for at least 3 years with moderately elevated blood sugar (HbA1c 7%–10%) - You are currently on blood sugar medication (insulin, metformin, sulfonylureas, or SGLT2 inhibitors) - You are medically stable and have not taken any experimental drug in the past 6 months **You may NOT be eligible if:** - You have contraindications to MRI or contrast agents - Your kidney function is significantly reduced (eGFR below 45) - You are already taking a GLP-1 receptor agonist (the same class as semaglutide, e.g., Ozempic, Trulicity) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSemaglutide Auto-Injector

Subjects have an equal chance of receiving semaglutide or placebo. Which treatment subjects receive is decided at random by a computer (purely by chance, like the tossing of a coin). Neither subjects, Study Site personnel nor image reviewers will know which treatment subjects are assigned to. The study drug must be taken weekly. The subject's other medications may be changed by the study's un-blinded Endocrinologist. At baseline subject will receive and take home 0.25mg injector for use 3 more times. They will be given a 0.5mg injector and a 1mg injector for use beginning 5 and 9 weeks from baseline respectively. The target dose for subjects is 1mg per week up to the 52 week treatment duration.

OTHERPlacebo

Placebo

Locations(1)

University of Washington - Harborview Medical Center

Seattle, Washington, United States

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NCT05780905

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