Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: cerebrovascular
- Who it enrolls
- age 40 Years to 65 Years; no BMI minimum stated; conditions: Diabetes Mellitus, Type 2; Stroke (CVA) or Transient Ischemic Attack
- Interventions
- Semaglutide Auto-Injector; Placebo
- Conditions
- Diabetes Mellitus, Type 2; Stroke (CVA) or Transient Ischemic Attack
- Phase and size
- Phase 4 · 50 participants
- Dates
- Start 2024-01-11
Primary completion 2026-03-31 - Sponsor
- University of Washington (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Intracranial blood flow (IBF)Approximately 12 Months
- bloodbrain barrier KtransApproximately 12 Months
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.