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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

• Willing to participate and sign informed consent.

Locations
United States
Washington
University of Washington - Harborview Medical Center
RECRUITING
Seattle
Contact Information
Primary
Francis Kim, MD
fkim@u.washington.edu
206-744-8305
Time Frame
Start Date: 2024-01-11
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Placebo_comparator: Placebo
Subjects randomized to placebo for 1 year.
Active_comparator: Active
Subjects randomized to semaglutide for 1 year.
Sponsors
Collaborators: Novo Nordisk A/S
Leads: University of Washington

This content was sourced from clinicaltrials.gov