Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-65
SponsorUniversity of Washington
About this trial
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 criteria
Qualifiers
Men and women 40-65 years of age
Subjects with type-2 diabetes >= 3 years and HbA1C 7%-10% with blood sugar control medications including insulin, metformin, sulfonylureas, or SGLT2 inhibitors
Medically stable
Has not received any investigational drug in the past 6 months
Disqualifiers
Contraindication to MRI or contrast agent
eGFR<45 mL/min/1.73m2 (eGFR is a measurement of kidney function)
Currently treated with glucagon-like peptide-1 receptor antagonist (same drug class as study intervention)
Unable to perform home-glucose monitoring
Trial design
Treatments tested in this trial
- Semaglutide Auto-Injector
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Washington
Lead sponsor
Novo Nordisk A/S
Collaborator
Source ClinicalTrials.gov