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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05780905
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Auto-Injector — DRUG
    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.
  • Placebo — OTHER
    Placebo

Study Details

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.

Key Dates

Start date
Jan 11, 2024
Status verified
May 2024
Primary completion
Mar 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Placebo Comparator: Placebo
    Subjects randomized to placebo for 1 year.
  • Active Comparator: Active
    Subjects randomized to semaglutide for 1 year.

Primary Outcome Measure

Intracranial blood flow (IBF) [ Time Frame: Approximately 12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington - Harborview Medical CenterSeattleWashington98104
Francis Kim, MD
[email protected]
206-744-8305
Francis Kim, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Washington - Harborview Medical Center· Seattle, WA

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